• Research article
  • Open access
  • Published: 05 February 2021

The STS case study: an analysis method for longitudinal qualitative research for implementation science

  • Jennifer M. Van Tiem 1 , 2 ,
  • Heather Schacht Reisinger 1 , 2 , 3 , 4 ,
  • Julia E. Friberg 1 , 2 ,
  • Jaime R. Wilson 1 , 2 ,
  • Lynn Fitzwater 5 ,
  • Ralph J. Panos 5 &
  • Jane Moeckli 1 , 2  

BMC Medical Research Methodology volume  21 , Article number:  27 ( 2021 ) Cite this article

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Ethnographic approaches offer a method and a way of thinking about implementation. This manuscript applies a specific case study method to describe the impact of the longitudinal interplay between implementation stakeholders. Growing out of science and technology studies (STS) and drawing on the latent archaeological sensibilities implied by ethnographic methods, the STS case-study is a tool for implementors to use when a piece of material culture is an essential component of an innovation.

We conducted an ethnographic process evaluation of the clinical implementation of tele-critical care (Tele-CC) services in the Department of Veterans Affairs. We collected fieldnotes and conducted participant observation at virtual and in-person education and planning events ( n  = 101 h). At Go-Live and 6-months post-implementation, we conducted site visits to the Tele-CC hub and 3 partnered ICUs. We led semi-structured interviews with ICU staff at Go-Live (43 interviews with 65 participants) and with ICU and Tele-CC staff 6-months post-implementation (44 interviews with 67 participants). We used verification strategies, including methodological coherence, appropriate sampling, collecting and analyzing data concurrently, and thinking theoretically, to ensure the reliability and validity of our data collection and analysis process.

The STS case-study helped us realize that we must think differently about how a Tele-CC clinician could be noticed moving from communal to intimate space. To understand how perceptions of surveillance impacted staff acceptance, we mapped the materials through which surveillance came to matter in the stories staff told about cameras, buttons, chimes, motors, curtains, and doorbells.

Conclusions

STS case-studies contribute to the literature on longitudinal qualitive research (LQR) in implementation science, including pen portraits and periodic reflections. Anchored by the material, the heterogeneity of an STS case-study generates questions and encourages exploring differences. Begun early enough, the STS case-study method, like periodic reflections, can serve to iteratively inform data collection for researchers and implementors. The next step is to determine systematically how material culture can reveal implementation barriers and direct attention to potential solutions that address tacit, deeply rooted challenges to innovations in practice and technology.

Peer Review reports

Ethnographic approaches offer both a method and a way of thinking about implementation science. As method, ethnography offers specific ways to document and track the implementation process in health services research. These include rapid cycle assessment [ 1 , 2 ], periodic reflections [ 3 ], and pen portraits [ 4 ], which are based upon the triangulation of multiple, diverse data sources (i.e., participant observation, in-depth interviews, document review) [ 5 , 6 ]. As a way of thinking, ethnography orients researchers and implementors to “everyday” contexts, which includes the local and the lived experience, as well as the tacit and implied [ 7 , 8 ]. Applied to process evaluations [ 9 , 10 , 11 ], adaptation and tailoring [ 3 ], and facilitation [ 5 ], the primary contribution of an ethnographic approach to implementation science [ 12 ] is its comparative and holistic examination of people’s social worlds in relationship to newly introduced interventions.

We seek to contribute to the literature on ethnography in implementation science by illustrating an approach of the case study method that we believe is well-suited to describe the impact of the longitudinal interplay between implementation stakeholders. Case studies are a familiar way to present ethnographic findings related to implementation processes [ 13 , 14 ]. In this article, we demonstrate a form of the case study method that grows out of science and technology studies (STS) and draws out the latent archaeological sensibilities implied by ethnographic methods [ 15 , 16 , 17 , 18 ]. Archeological insights are gleaned from attention to material culture, or the “stuff” with which people carry out the work of their everyday lives. Stories about how people carry out their lives with their stuff has been the work of ethnography since its inception as a method [ 19 ], but STS shifts the point of view of the narrator. Rather than stories told from the perspective of the human actors, STS starts with the material object and builds stories about the world based on how things and people share and shape each other through social practices [ 15 , 20 ].

This kind of storytelling is familiar to doctors and nurses, who “expect the patient to tell a story about daily life-events in which entities of all kinds (beans, blood, table companions, cars, needs, sugar) coexist and interfere with one another” [ 16 ]. Writing an STS case study challenges researchers to “tell stories about medicine” that read like “a good case history” [ 16 ]. To illustrate the potential of this method, in this article we “recover archaeologically and interrogate ethnographically” part of the process of implementing critical care telemedicine (Tele-CC) in the Department of Veterans Affairs (VA) [ 21 ]. By tracing the Tele-CC implementation process through people’s use and manipulation of elements of material culture, we will ground our interpretation of our observations and interviews in some of the actual objects people handled every day in their interactions with Tele-CC. We engaged with sites through repeated brief encounters over several years. As a result, we will be able to describe the contextual shaping of Tele-CC implementation through time, as well as across sites at specific points in time.

We argue that this form of case study (termed an “STS case study”) is a novel form of longitudinal qualitative research (LQR) that allows implementors to understand and impact the implementation process by distilling a lot of diverse data [ 22 , 23 ] into summaries and categories that make it possible to follow and understand change over time [ 23 ]. LQR is both a method for data collection and data analysis. Data collection based on LQR involves ethnographic engagement [ 24 ] and data analysis techniques requiring both cross-sectional and longitudinal examinations [ 22 , 25 ]. Taken together, these data collection and analysis strategies make complexity digestible. Qualitative researchers in implementation science have picked up and used LQR to track adaptations through periodic reflections [ 3 ] and pen portraits [ 4 ]. Periodic reflections are a format for guided discussions, conducted over time, that serve as a record of an implementation effort [ 3 ]. A pen portrait organizes data from different sources, at different time points, together in one document; it is like a collage describing one site where an innovation is being implemented [ 4 ]. Both periodic reflections [ 26 , 27 , 28 , 29 ] and pen portraits [ 30 , 31 ] have been used in the field to help develop study protocols; pen portraits have also been used as a method of data analysis [ 32 , 33 ]. As a novel form of LQR, the STS case study method introduces the opportunity to engage with material culture, and thus contributes a way to focus and re-focus, or calibrate, the analytic lens, or to look for how local use and understanding of the material elements of an intervention changes over time, and what that could mean for the normalization [ 34 , 35 , 36 ] of the implementation as a whole. The aims of this paper are twofold: 1) to contribute to the literature on the role of ethnography in implementation science; and to achieve that by providing a case study about 2) tracing how Tele-CC and ICU staff negotiate the implementation of surveillance technology.

The goal of the VA Tele-CC program is to expand and improve the quality of critical care delivery. In 2011–2012, two Tele-CC programs launched in VA utilizing Philips eCareManager. Currently, two hubs with attendant satellite-hubs, serve approximately 30% of VA ICUs. In 2016, one of the two Tele-CC hubs in VA partnered with eight ICUs that were primarily lower-resourced, smaller, and located in geographically isolated rural hospitals that have been especially affected by the national shortage of critical care-certified physicians and nurses [ 37 , 38 , 39 ]. The VA Office of Rural Health (ORH) funded the provision of Tele-CC in these ICUs. Tele-CC includes bedside physiologic monitor upgrades, continuous monitoring, night and weekend tele-intensivist support, and on-demand support for emergency departments. It is a technological innovation that requires both the unidirectional flow of data inputs (e.g., vital signs and labs) from the bedside to the Tele-CC, as well as teamwork between ICU and Tele-CC staff to make decisions based on these inputs and provide care. Proprietary Philips algorithms built into the Tele-CC system alert Tele-CC staff to acute physiologic concerns (e.g., sepsis alert), and the Tele-CC staff then investigate by reviewing the inputs and connecting with the ICU staff.

Prior research has shown mixed results related to staff acceptance of Tele-CC [ 40 ]. Knowing this, external facilitators [ 41 , 42 , 43 ] built a community of practice around Tele-CC through commitment work [ 35 , 44 ] characterized by a series of implementation strategies related to planning and education (i.e., building buy-in, developing relationships, developing materials, and educating) [ 45 ] that unfolded over time through virtual and in-person events. There were separate and coinciding technical, clinical, and interface implementation efforts. We followed the clinical implementation. Virtual “Clinical Information Calls” led by external facilitators and attended by internal facilitators pre-figured the in-person “Clinical Process Design Workshop (CPDW).” The Clinical Information Calls continued through an intensive 2-h Skype “Train the Trainer” that was followed by the culminating event, the in-person inauguration of Tele-CC services, or the “Go-Live.”

The Tele-CC nurses had all worked as bedside ICU nurses. They understood the protectiveness and emotional attachment characteristic of relationships between nurses, patients, and families in ICUs; they also understood that offering critical care virtually could disrupt relationships at the bedside. This manuscript will trace how Tele-CC and ICU staff negotiated mundane connections occurring within the daily flow of Tele-CC and ICU staff in and out of patients’ rooms. In the STS case study presented in this manuscript, we will model how to use STS and pay attention to aspects of material culture that may help implementors better understand and intervene upon Tele-CC implementation barriers.

Overall aim & Design

Elements of our ethnographic process evaluation [ 9 ] have been laid out in a previous manuscript [ 46 ]; the supporting research was approved by the University of Iowa Institutional Review Board (IRB # 201311734). The clinical leader of the implementation (RP) formally introduced the evaluation team (HSR, JM, JVT, JF) at the Clinical Process Design Workshop, which served as a kick-off meeting for each new round of sites. During subsequent site visits and in conversation with participants, the evaluation team introduced themselves as social scientists. We indicated that we would report our findings to the VA Office of Rural Health, which was funding the evaluation of the implementation of Tele-CC in rural sites across the United States (Award # 14385).

Over the course of 16 months, the evaluation team conducted participant observation, including producing fieldnotes [ 47 ], document review, and interviewing using qualitative techniques (e.g., root questions) [ 48 ]. We analyzed our data by first organizing segments of fieldnotes and interview transcripts according to categories [ 49 ] of implementation strategies and then according to complementarity of information across types of data (observations and fieldnotes, documents, and interviews) collected longitudinally [ 4 ], in order to build a case study in the tradition of STS. Across our data collection and analysis, we used verification strategies [ 50 ] in order to ensure the reliability and validity of our process and findings.

In this article, we will trace how external facilitators used planning and educating implementation strategies (e.g., building buy-in, developing relationships, developing materials, and educating) to normalize Tele-CC. Specifically, we will focus on the conversations around the doorbell (a chime that would ring over the speaker in the patient’s room), a feature of the Tele-CC that Tele-CC staff use to mark their impending presence in the ICU room. The focus on the material culture of the doorbell developed during the iterative analysis process (see analysis section below). We used ethnographic data collection techniques through time, as well as across sites at one point in time. As a result, we were able to produce stratigraphic observations and horizontal exposures of the tensions around the doorbell, and thus generate a partial ethnography of the uneven normalization of Tele-CC in VA.

Setting & characteristics of participants

Our continuous virtual ethnographic engagement with the implementation of Tele-CC was punctuated by in-person site visits and presence at training events. The evaluation team was included on the list of attendees at virtual events and meetings, alongside internal and external facilitators. Prior to site visits, internal facilitators and ICU staff were approached via email regarding interviews with the evaluation team. A convenience sample of external and internal facilitators, as well as ICU staff, was selected based on their presence and involvement in the implementation of Tele-CC. Participation in interviews with the evaluation team was not mandatory; however, no one outright refused to participate. External and internal facilitators from the Tele-CC and ICUs included intensivists, advanced practice nurses, and nurse managers. ICU staff included intensivists, hospitalists, nurse managers, nurses, telemetry techs, and nursing assistants across all shifts. This article reports on fieldnotes from virtual events, including the Clinical Implementation Calls and Train the Trainer event, as well as our fieldnotes and interviews at in-person events, including the Clinical Process Design Workshops (CPDW) and sites visits at three ICUs that adopted Tele-CC.

Data collection

Three ethnographers, with post-graduate degrees in geography, public health, and anthropology (JM, JF, and JVT, respectively) led the data collection efforts. We collected fieldnotes throughout the implementation process. During the virtual events (Clinical Information Calls, Train the Trainer), we called into the meetings and were largely silent; our presence was registered on the attendee list. At in-person events (CPDW, Go-Live), we embedded ourselves within small groups and participated with them in whatever activities were taking place. At 6-months post-implementation, we returned to the sites and conducted semi-structured interviews with ICU staff and internal facilitators.

Observations and Fieldnotes

During virtual events, JF and JVT observed conversations between external facilitators and internal facilitators. Conversations revolved around technical readiness, information about dates and times of upcoming events (CPDW, TTT, Go-Live), questions from the internal facilitators, and, post-CPDW, an in-depth review of each workflow layering Tele-CC into ICU practice. During the CPDW, we took notes on the lecture accompanying the PowerPoint Presentation, questions posed by internal facilitators, conversations among internal facilitators, the simulation demonstrating how the Tele-CC can assist ICUs, and the process of developing workflows. During Go-Live events, we took notes on small-group training sessions and simulations. In total, we conducted 101 h of observation (42 h during the Clinical Information Calls, 4 h during the Train the Trainer sessions, 35 h at the CPDWs, and 20 h at the Go-Live events).

Document retrieval

JF and JVT collected copies of distributed materials, including PowerPoint presentations, workflow diagrams, training templates, brochures for doctor orientation and patient and family guides, as well as copies of the scripts for training simulations. In this article, we focus specifically on the elements of the documents that focused on the doorbell, including several PowerPoint slides, and the workflow diagrams around “Camera Etiquette” (see Additional file 1 ).

Semi-structured interviews

During Go-Live, and then at 6-months post implementation, JM and JVT conducted semi-structured qualitative interviews using qualitative techniques, including linguistic intentionality, root questions, and grounded probes, in order to solicit multiple perspectives and make space to question assumptions [ 48 ] (Additional file 2 ). To promote conversation and reflexivity [ 51 ], two researchers co-led each interview. At the initiation of Tele-CC services at the site, we asked questions about the structure and function of the ICU and the patient population, preparations they had made for the implementation of the Tele-CC, as well as their knowledge about the Tele-CC. At 6-months post-implementation, we asked questions about staff expectations and perceptions of the Tele-CC, as well as how they had used it. Interview duration was based on participant availability; however, no interview lasted longer than 60 min. Interviews were audio recorded, transcribed by trained transcriptionists, and uploaded into MAXQDA for analysis [ 52 ]. Transcripts were not returned to participants for comment or correction, however we did do some member-checking [ 53 ] during repeat interviews either with the same individual, or individuals who occupied the same role, as we visited the same three ICUs at Go-Live and then 6 months post-implementation. Details about these interviews are reported in an earlier manuscript [ 46 ]; additional information is included in Table  1 (below).

Data analysis

The analysis described here was conducted for the specific objectives noted above and reflects a small part of the larger evaluation of Tele-CC implementation in VA conducted by our team [ 46 , 54 , 55 ]. Throughout our evaluation, JM, JF, and JVT used qualitative data verification strategies, to ensure the reliability and validity of our data collection and analysis process [ 50 ]. We have also been guided by Normalization Process Theory [ 34 , 35 , 36 ]; for this analysis JVT, JM, and JF categorized each implementation process by the normalization work involved: enrolment, initiation, legitimation, or activation. These details are laid out in Table 1 .

After organizing the data in this way, JVT deductively coded [ 49 ] fieldnotes according to the implementation strategies of planning and education (i.e., building buy-in, developing relationships, developing materials, and educating) [ 45 ]. While deductively coding, JVT found that one of the most intact examples of a workflow, the one for “Camera Etiquette,” was also an element of the implementation for which we had a diverse pool of data (fieldnotes, interviews, and documents). JVT conducted lexical searches across fieldnotes and interviews for “workflow” and “camera.” JVT organized the coded segments that included the terms “workflow” and “camera” chronologically, according to elements of commitment work, and noticed a particularly potent interaction between an external facilitator and an internal facilitator around the idea of the doorbell. To draw out the potential tension, and collect data from as many voices as possible, JVT conducted another lexical search for “doorbell” in interviews with all staff interviewed 6-months post-implementation at the sites. Throughout this analytic process, JVT was in conversation with JM about the application of Normalization Process Theory as an etic frame, as well the possibilities afforded by approaching the data from the perspective of science and technology studies (STS). As a result, JM and JVT wrote the article in an iterative process, in conversations shaped by effective qualitative interview techniques designed to encourage reflexivity [ 51 ] and thus draw out the richness of the connections highlighted by the different forms of data (fieldnotes, documents, interviews) collected over time [ 4 ]. We refined the discussion and conclusions through discussions and writing with the clinical leader of the implementation (who was also the Medical Director of the Tele-CC) (RP), the external educator who co-led the Go-Live trainings (who was also an APRN in the Tele-CC) (LF), and a subject matter expert who was a former ICU nurse and current VA Rural Health Scholar (JW).

Following the doorbell through the layers of the implementation process, and then across three sites at 6-months post-implementation, we exposed how different and divergent notions of surveillance grew up through the implementation of Tele-CC. We pieced together this narrative about surveillance based on our ethnographic method of data collection. Concerns about surveillance are a barrier to staff acceptance of Tele-CC, and to understand how surveillance is a barrier, we can map the materials through which surveillance comes to matter. To tell stories about surveillance, ICU and Tele-CC staff implicated brochures, cameras, buttons, chimes, motors, baths, curtains, courtesy, nighttime, spying, post-operative confusion, and voices.

Tele-CC staff used the doorbell to signal their entrance into the patient’s room. Following the chime, the camera would turn on and swivel around to face the patient’s bed and the face of the Tele-CC clinician would appear on the computer monitor. In contrast, ICU staff used a combination of slower, protracted signals, including knocking on the door, or tentatively moving the curtain, in combination with verbal cues to enter a patient’s room. The chime of the doorbell and the inevitable whir of the camera’s motor as it rotated toward the patient were new sounds for ICU staff. In talking about these sounds, ICU staff found a way to express their concerns about surveillance and privacy, for their patients, for their relationship with their patients, and for themselves.

Stratigraphic (longitudinal) observations (site 3 through the implementation process)

During Clinical Information Calls, in working through the “Camera Etiquette” workflow, internal facilitators and external facilitators spent time addressing questions about standardizing times when Tele-CC staff planned to round on ICU patients, obtaining verbal agreement from the patient for the Tele-CC to camera in to their room, potential equipment malfunctions and, specifically, the doorbell. Over the course of several calls, the external facilitators and internal facilitators worked to refine the workflows to best reflect how the Tele-CC could be “layered in” to the existing practices of the ICU. During the Clinical Implementation Call on July 11, 2017, during the discussion of the workflow entitled, “Camera Etiquette,” Patricia, one of the internal facilitators from Site 3 queried Morris, one of the external facilitators about the doorbell. The exchange is transcribed from fieldnotes below:

Patricia (Site 3): Is there a bell you ring prior in case the patient is being bathed? Morris: Yes. You’ll hear the motor of the camera move. We’ll click and show our picture. Somewhere in there, they will press a button and it will ring a doorbell. Patricia: Perfect Morris: At night, we don’t do that. We surveyed our customer clinicians. Patricia: Did you have to put up a disclaimer or any notification that cameras are being used? Morris: We give a brochure to the staff. It is a VA Telehealth rule that all patients have to consent to the video. Our nurses have a script of what they say and they’ll get consent for the audio portion of the ICU. Less than 1% of all patients refuse the [Tele-CC]. No reason to refuse, they are getting additional physicians looking over them. Does not preclude your nurses from connecting with us, just we can’t camera into the room. (Fieldnote, Clinical Implementation Call, July 11, 2017; all names are pseudonyms)

The import of Patricia’s question, “ Is there a bell you ring prior in case the patient is being bathed ,” and Morris’s response, “ You’ll hear the motor … we’ll click and show our picture … they will press a button and it will ring a doorbell ,” is not clear until the Clinical Process Design Workshop (CPDW) event 3 months later, when we participated in a conversation with Patricia and her colleague to create workflows. Our fieldnotes read,

after [an external facilitator] explained that the doorbell would sound after the [Tele-CC] nurse was in the process of camera-ing in, and that bedside staff wouldn’t have direct decision making about whether or not to permit this access … the major concern she [Patricia] mentioned was privacy for patients. [Her colleague from Site 3] replied that it would probably be similar to how people walk in and out of rooms at the hospital when rounding on patients, potentially walking in on them in moments when privacy would have been preferred. Patricia responded to this by saying in a flat tone, “Not in my ICU.” (Fieldnote CPDW, September 2017)

Similarly, the significance of Morris’s clarification that “ at night, we don’t [ring the doorbell ],” was not obvious until the Go-Live event at Site 3 (4 months after the CPDW). In an interview, Patricia spoke with us about how,

“they [the Tele-CC staff] don’t like to ring the doorbell, middle of the night to check on the patient. I want them to and they went back and forth about this … it’s like I kept saying to them, when I go into a patient’s room, I knock on the door. So that’s why I want you to ring the doorbell … you know, if I’m going into a patient’s room just with the curtains drawn, I’m gonna knock, I’m gonna say, ‘This is the nurse … [okay] if I stick my head in?’ You know? And they’ll say yes or no … but that’s the same thing I want the courtesy of the, of the doorbell.” (Site 3 T1, RN ICU)

During Go-Live, Morris oriented staff to Tele-CC through training sessions with small groups. After a brief lecture about the history of Tele-CC, Morris encouraged bedside staff to practice engaging with the Tele-CC by hitting the green button newly installed in each ICU room. In encouraging engagement with the Tele-CC, Morris specifically mentioned the doorbell. A fieldnote from one of these small groups describes his characterization of the doorbell:

Morris explains that … the hub staff can call in to the room from their end but will not do so without using a “doorbell” to buzz in to let staff and patients know that they are doing so. The camera will also rotate into the room to alert patients and on-site staff when hub staff call in. Morris has both [trainees] practice answering potential questions from patients and visitors about the cameras and the Tele-CC program along the lines of: “What is that thing? Why is it in here?” Morris also asks them to respond to a patient saying, “I don’t want it spying on me,” to which [the trainees] reply that it won’t do that. (Site 1 T1, Fieldnote)

Morris’ admonition to the trainees presages the implication of Patricia’s question about “ putting up a disclaimer or any notification about cameras,” which became visible 6 months post implementation (June 2018). Patricia had left her position, but another internal facilitator from Site 3, Forrest, who had attended the Clinical Process Design Workshop with Patricia, relayed how,

“[if] there’s no nurse in the room and there’s the [Tele-CC] nurse practitioner, you know, and the patient’s like, ‘What? I can’t hear you,’ … [and] we [the ICU nurses] didn’t hear the doorbell and then we didn’t answer it … I think that those are the kinds of opportunities we have to ensure that it’s a good patient experience … Many of our patients come post-operatively where they’re not able to be oriented [to the Tele-CC] and they could be very confused … that all of a sudden somewhere out of space a voice is coming from this thing on the wall” (Site 3 T2, MD ICU)

Retrospectively piecing together the arc of the implementation process by threading a narrative through mentions of a material object (e.g., a doorbell) was a way to re-situate ourselves in the flow of the original timeline of implementation. We developed a sense of what the doorbell was connected to (i.e., concerns about surveillance). As a result, we anticipated that looking for when people talked about the doorbell during our interviews 6-months post implementation might help us understand how conversations about surveillance changed, and also how these conversations differed across sites. Our “good case history” helped us contextualize and better understand discussions at 6-months. Looking retrospectively was a way to understand prospectively.

Horizontal (Cross-Sectional) Exposure (6-months post implementation at Site 1, Site 2, and Site 3)

Each of these threads of Patricia’s concerns were borne out amongst the ICU staff at six-months post implementation with bedside staff at Site 3. Nurses at Site 3 relayed how,

“They’re supposed to ring the doorbell. I don’t know if we don’t hear the doorbell? But we certainly don’t know when they’re gonna just pop in, usually. (Site 3 T2, RN2)
“We were under the impression … when it first got initiated, there was going to be a doorbell before any camera turning, any monitor pop … and they were supposed to talk, for instance, “Is it okay if we come in?” and that is not the case.” (Site 3 T2 RN5)
“There’s been at least three instances where they have just come in while I’ve had a patient either on the commode or standing there urinating, and I was under the impression that we could deny them entry—[P2: (overlapping) That they’re supposed to … ring a doorbell.] … Well, the doorbell rings, but then it just turns off. [P2: Oh, I don’t even hear it, yeah] … Y-you got the green button, but there should also be a red button, so if you hear the chime, you can push the red button and they WON’T come in.” (Site 3 T2 RN6 & RN 7)

Not all ICU nurses shared the perspective of the nurses at Site 3. At Site 1, we engaged two bedside nurses, who had not been internal facilitators during the implementation, in the following conversation about the doorbell at 6-months post implementation:

“[I1: We’ve heard from several different folks we’ve talked to across sites that there’s anxiety about [Tele-CC] just camera-ing into the room without calling first or ringing the doorbell. Because you had that previous set of interactions with them, has that anxiety waned?] P1: It does still surprise us sometimes when we hear a voice in there and we’ll think, “Oh, I didn’t hear the doorbell,” [I1: Yeah.] you know, so [P2: (Overlapping) Hmm yeah] sometimes the doorbell … doesn’t ring … and so they’ve [P2: Yeah.] caught us off-guard. Sometimes we’ll be in there moving a patient or something and they’ll [P2: Oh!] uh (chuckles) … We know that they will um pop in between, say, eight o’clock and nine or ten [P2: Mm-hmm.] and do an assessment on the patient, so when we hear that we’re used to hearing ‘em, but we just don’t, a lotta times don’t hear the doorbell
[I1: I see so when you hear ‘em, what do you hear?] P1: Just voices talking … They talk to the patients … [and we wonder to each other] Is that your patient? Who are they talking to? (chuckles) And then we realize it’s probably [Tele-CC] that they’re talking to
[I1: Okay so walk me through that.] P1: (Laughs) Well just sometimes it, you know, it’s eight, nine o’clock and you’ll hear someone that you-- and you’re wonderin’, is their family member in with that patient or, you know, something like that and then we kinda listen to the conversation a little bit because the [Tele-CC] has a sound, you know, [P2: Hmm.] it’s uh-- doesn’t it? Doesn’t it? It’s different than just some-- just us— [ P2: (Overlapping) Yeah, tell it’s on a speaker.] P1: Yes … Kind of an echo. [P2: Like, now if you’re listening to a radio or something, you can tell they’re-- --not right beside you. It’s--] P1: It’s a different kind of sound [P2: Mm-hmm.]. P1: It’s a different conversation than us just talking... we don’t hear it all the time, you know, and so we-we haven’t learned to assimilate it into our-our book of sounds
[I1: What does that feel like to know that there’s another presence kind of like paying attention to all of the … ] P1: (Pause) At first, it was a little uh anxious, or a little irritating just because someone else is coming in and havin’ eyes on your patient, but their-- they don’t, they don’t butt in [I1: Okay.] is what I have found. They don’t butt into the care that I’m giving.” (Site 1 T2 RN Night Shift)

At Site 2, nurses we spoke with did not mention the doorbell when they reflected on how Tele-CC staff entered patient rooms and initiated conversations. One nurse remembered how,

“I mean uh you know [they have] popped in and you know ‘how’s he doing and how’s this and how’s that.’ And converse with the people who are there. I mean I, like I said I’m fine with it. Some people I think, were very apprehensive about it. But even the people that were very apprehensive, I think that after they got used to it, they didn’t care. I mean [the Tele-CC staff] would go on ahead and they were popping in on the patients. And you know when someone’s got their door closed like over here, and the family member’s in there and that shade is pulled. Guess what? You know [Tele-CC] pops in and of course they’re gonna flag us if there’s a problem. So that’s a good thing to have.” (Site 2 T2 RN3)

Ultimately, staff at Site 3 wanted to be able to limit Tele-CC virtual entry into their ICU rooms. Staff at Site 1 and Site 2, despite having some similar misgivings about the shifting dynamic of relationships between the Tele-CC, ICU, and patient, did not feel the same way. At Site 3, the conversation hardened around hearing or not hearing the doorbell, and wanting the opportunity to hear the doorbell. At Site 1, the staff also missed the sound of the doorbell, but focused instead on how the “different kind of sound” produced by the Tele-CC signaled “a different conversation” at the bedside. Staff at Site 2 did not mention the doorbell when they recollected interactions with the Tele-CC, but they also noticed the sound of the conversation between the Tele-CC and patient; what is more, they perceived how the Tele-CC could help them circumvent barriers to entering the room (e.g., closed doors, pulled shades) that the patient and family sometimes imposed.

The ICU is a place full to bursting with sounds. Patients risk developing “ICU delirium” as a result, in part, of the sounds associated with continuous monitoring of vital signs [ 56 ] and some nurses we spoke to talked about having a “book of sounds.” We witnessed nurses respond strategically to different sounds; turning off some “alarms,” but noticing immediately and acting decisively when a sound indicated a patient was in trouble. The sound of the doorbell was new. As a noise in the ICU, the chime was an unfamiliar aural presence [ 57 , 58 ] that inadvertently encouraged nurses to notice other foreign presences accompanying the implementation of the Tele-CC.

By “recovering [the doorbell] archaeologically and interrogating [the doorbell] ethnographically” [ 21 ], we have demonstrated the utility of the STS case study as a contribution of ethnography to implementation science. While ethnography exposes the mundane particularities of an implementation, science and technology studies (STS) helps us think about how those things come to matter. Specifically, STS case-studies contribute to the literature on longitudinal qualitive research (LQR) in implementation science, including pen portraits [ 4 ] and periodic reflections [ 3 ]. Like periodic reflections and pen portraits, the STS case-study provides a way to engage with the complexity of an implementation process by tracing changes over time through interviews and observations. However, the form of an STS case-study is unique. Rather than a clean case summary, it is more like a complex case history full of the mundane bits and pieces like those pointed out by Mol and Law; here, rather than “beans, blood, [and] table companions,” we followed brochures, cameras, buttons, chimes, motors, curtains, and voices [ 16 ].

Both ICU and Tele-CC staff enter patient rooms, but they do with different tools, with different “stuff.” Bedside nurses have a curtain or a door; Tele-CC nurses have a camera that turns around and a chime they call a “doorbell.” Entering patients’ rooms implicates cameras, chimes, motors, curtains, and voices, and negotiations about how to use this stuff, sparks concerns about how ICU and Tele-CC nurses differently acknowledge movement from the communal space in the ICU to the intimate space of the patient’s room. The material stuff associated with the presence of the Tele-CC (e.g., the camera, speaker, and monitor) are already located in the patient’s room, and so we must think differently about how a Tele-CC nurse could be noticed moving from communal to private.

Though labor intensive, the components of ethnography (e.g., participant observation, fieldnotes, archival research, and interviews) generate a field of data that can be analyzed archaeologically (e.g., across and within sites, at one moment in time and over time) and as a consequence allow us to notice tacit and implied beliefs that impact an implementation process. As researchers, we did not initially know to ask about the doorbell, and it was only after combing through our fieldnotes and collected documents that we were able to trace conversations about the doorbell to planning and educating materials pre-implementation, and then forward to conversations among ICU staff 6-months post-implementation. Anchored by the material, the heterogeneity of an STS case-study generates questions (e.g., why did Patricia demand the doorbell be rung at night? Is she concerned about privacy for her staff, or the patients, or both?) and encourages exploring differences (e.g., how did nurses at Site 1 let go of wanting the sound of the doorbell and embrace the different sounds of the Tele-CC? When did the nurses at Site 2 begin to see the Tele-CC as a way for them to see into the room?). Begun early enough, the STS case-study method, like periodic reflections, can serve to iteratively inform data collection for researchers and implementors.

Tele-CC staff need a metaphor that positions the Tele-CC differently vis à vis the ICU (e.g., not a doorbell, but maybe an “arrival chime”). Terming the sound a “doorbell” implies that ICU staff may not permit Tele-CC to enter the room, much like when someone rings a doorbell at a house and the owner chooses whether to invite entry. In our context, the Tele-CC are part of the standard of care (i.e., Tele-CC cannot be denied entry into a patient’s room). Tele-CC staff recognize that ICU staff have a strong sense of autonomy in their practice and they wonder if using the term “doorbell,” and thus (incorrectly) implying that ICU staff can deny Tele-CC staff entry in to the room, creates uncertainty among ICU staff related to their own autonomy and the authority of the Tele-CC. The goal is to initiate contact with a sound that signals collaboration and partnership. Future research should explore how one negotiates virtual entry to an intimate, private space in a way that fosters teamwork.

Limitations

Our study has several limitations. First, teamwork between ICU and Tele-CC staff is so complex that 6-months is not enough time for Tele-CC and bedside staff to become familiar or comfortable with each other; in fact, it could take longer than 6 years to build trustful relationships [ 59 ]. Our data collection plan ended at 6-months post-implementation, so we did not have the opportunity to observe and learn about how staff interacted with the doorbell in the context of more trusting relationships between the ICU and Tele-CC staff. Secondly, we have no information about how patients perceive the sound of the doorbell. Finally, we do not have data gleaned from interview guides informed directly by our new understanding of the import of the doorbell. If we had the opportunity to go back to these sites, we could ask them questions that might draw out this information. However, using the STS-case study method, we were able to denote a pattern that may indicate that staff who are normalizing the sounds associated with Tele-CC may be exhibiting higher levels of acceptance of Tele-CC a part of their practice.

The STS case-study is a tool for implementors to use when a piece of material culture is an essential component of implementation. In the context of an ethnographic process evaluation of the implementation of Tele-CC services in Department of Veterans Affairs Medical Centers, the STS case-study helped us realize that we must think differently about how a Tele-CC nurse could be noticed moving from public to private space. The next step in the development of the STS case-study research method is to develop tools that will guide implementers through the STS case-study method to determine systematically how material culture can reveal implementation barriers and direct attention to potential solutions that address tacit, deeply rooted challenges to innovations in practice and technology.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Clinical Process Design Workshop

Intensive Care Unit

Longitudinal Qualitative Research

Science and Technology Studies

Tele-Intensive Care Unit (previously abbreviated as Tele-ICU)

Train the Trainer

Veterans Affairs

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Acknowledgments

The authors acknowledge technical support for transcription and qualitative data processing from Monica Paez, Vu-Thuy Nguyen, Elizabeth Newbury, and Chelsea Hicks. We also wish to express our appreciation for the VA staff who participated in this study to inform the implementation of tele-critical care. Finally, we would like to acknowledge the VA Office of Rural Health for funding the tele-critical care evaluation.

Funding provided by the U.S. Department of Veterans Affairs (VA) Office of Rural Health, Veterans Rural Health Resource Center- Iowa City (Award 14385). Visit www.ruralhealth.va.gov to learn more. Support is also provided by the Health Services Research and Development (HSR&D) Service through the Center for Access and Delivery Research and Evaluation (CADRE) (CIN 13–412). The Department of Veterans Affairs had no role in the analysis or interpretation of data or the decision to report these data in a peer-reviewed journal. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government.

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Contributions

We have 7 authors. We worked as a research team. The PI for this project was HSR. As such, she provided substantial contributions to the conception and design for data collection; she also revised the paper for important intellectual content. The research team for this project consisted of JVT, JF, and JM. As such, they provided substantial contributions to the design of data collection and acquisition of data, as well as providing revisions to early drafts of the article. JM and JVT contributed to the interpretation of the data through conceptual framing and theoretical expertise during the analysis. JW, LF, and RP served as subject matter experts in the field of critical care and Tele-CC. All authors contributed to the analysis and interpretation of data at various stages, though the analysis for this paper was led by JVT. Every author participated in the revising and drafting of this final manuscript and approved this version for submission for publication. Every author agrees to be accountable for all aspects of the work. All authors have read and approved the manuscript.

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Van Tiem, J.M., Schacht Reisinger, H., Friberg, J.E. et al. The STS case study: an analysis method for longitudinal qualitative research for implementation science. BMC Med Res Methodol 21 , 27 (2021). https://doi.org/10.1186/s12874-021-01215-y

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  • Longitudinal qualitative research
  • Science and technology studies
  • Implementation
  • Telemedicine
  • Critical care
  • Ethnography

BMC Medical Research Methodology

ISSN: 1471-2288

longitudinal case study qualitative research

How to … do longitudinal qualitative research

Affiliations.

  • 1 Medical Education Unit, University College Cork, Cork, Ireland.
  • 2 Faculty of Educational Sciences, University of Helsinki, Helsinki, Finland.
  • 3 Centre for Medical Education, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, Northern Ireland, UK.
  • PMID: 32588545
  • DOI: 10.1111/tct.13203

In health professions education, we are often interested in researching change over time, for example the development of professional identity or the adoption of new practices. Taking a longitudinal qualitative approach to such research can provide valuable insights. In this article, we present some longitudinal qualitative methods to support researchers interested in getting started with this type of research. We discuss what longitudinal qualitative approaches offer, consider the challenges and suggest how to go about it. We also highlight some specific ethical considerations that may arise in longitudinal studies.

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Common Methodologies found in Graduate Psych Research

Welcome, 

This guide aims to provide an overview of various research methodologies most frequently encountered in graduate psychology research studies.

Methodologies

1. Experimental Methodology:

The experimental method involves manipulating one variable (independent variable) to observe the effect it has on another variable (dependent variable), while controlling for extraneous variables. It is used to establish cause-and-effect relationships between variables in controlled laboratory settings.

Key Concepts: Randomization, Control Group, Experimental Group, Internal Validity.

2. Survey Methodology:

Description: Surveys involve collecting data from a sample of individuals through questionnaires or interviews, with the aim of generalizing the findings to a larger population. It is commonly used in psychology to gather information on attitudes, behaviors, and opinions from diverse populations.

Key Concepts: Sampling Techniques, Questionnaire Design, Reliability, Validity.

3. Observational Methodology:

Description: Observational studies involve systematically observing and recording behavior in naturalistic settings without intervening or manipulating variables. This method is used to study behavior in real-world contexts, offering insights into naturally occurring phenomena.

Key Concepts: Participant Observation, Non-Participant Observation, Ethnography, Observer Bias.

4. Case Study Methodology:

Description: Case studies involve in-depth examination of a single individual, group, or phenomenon, utilizing various data sources such as interviews, observations, and archival records. Case studies are valuable for exploring complex or rare phenomena in-depth, providing detailed insights into specific cases.

Key Concepts: Rich Description, Longitudinal Analysis, Generalization.

5. Correlational Methodology:

Description: Correlational studies examine the relationship between two or more variables without manipulating them, focusing on the extent and direction of their association. This method identifies patterns and associations between variables, informing predictions and further research directions.

Key Concepts: Correlation Coefficient, Directionality, Third Variable Problem.

6. Qualitative Methodology:

Description: Qualitative research focuses on understanding and interpreting subjective experiences, meanings, and social processes through methods such as interviews, focus groups, and textual analysis. The qualitative method provides nuanced insights into individuals' perspectives, cultural contexts, and social phenomena, often used in exploratory or theory-building research.

Key Concepts: Thematic Analysis, Grounded Theory, Reflexivity, Saturation.

7. Mixed Methods:

Description: Mixed methods research combines qualitative and quantitative approaches within a single study, allowing researchers to triangulate findings, enhance validity, and gain comprehensive understanding. Mixed methods offer the flexibility to address complex research questions by leveraging the strengths of both qualitative and quantitative methodologies.

Key Concepts: Integration, Sequential Design, Convergence, Expansion.

8. Quantitative Methodology:

Description: Quantitative research involves collecting and analyzing numerical data to test hypotheses, identify patterns, and quantify relationships between variables using statistical techniques. This method is widely used in psychology to investigate relationships, trends, and causal effects through numerical data analysis.

Key Concepts: Hypothesis Testing, Descriptive Statistics, Inferential Statistics, Measurement Scales.

9. Longitudinal Methodology:

Description: Longitudinal studies involve collecting data from the same participants over an extended period, allowing researchers to observe changes and trajectories of variables over time. Longitudinal studies are used to investigate developmental processes, life transitions, and long-term effects of interventions or treatments in psychology.

Key Concepts: Panel Designs, Cohort Studies, Attrition, Retention Strategies. 

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Hagen S, Bugge C, Dean SG, et al. Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT. Southampton (UK): NIHR Journals Library; 2020 Dec. (Health Technology Assessment, No. 24.70.)

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Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

Chapter 6 longitudinal qualitative case study.

  • Introduction

This chapter reports the methods and findings from the longitudinal qualitative case study. In line with contemporary process evaluation guidance, this is an in-depth, pre-planned and theoretically driven longitudinal, comparative, qualitative case study to support understanding of two complex interventions that aim to reduce UI in women. 53 In this chapter, we refer to the interview participants as women, in recognition of the fact that this chapter is based on women’s interview accounts (rather than using the term ‘participants’ as elsewhere in the report).

In this chapter, the longitudinal qualitative comparative case study will be referred to as the case study. Given the link between this study and the main OPAL trial, the same conventions in terms of referral to group allocation will be adhered to: specifically, when referring to the basic PFMT group we are referring to women allocated to basic PFMT group (ITT), whether or not the women adhered to treatment or crossed over treatment group; similarly, when referring to the biofeedback PFMT group, we are referring to women allocated to the biofeedback PFMT group.

When quotations are presented, they are followed by the case number of the woman, the interview (0M for baseline, 6M for 6 months, 12M for 12 months and 24M for 24 months) and the woman’s group allocation.

This chapter addresses one aim from the OPAL trial, namely to:

  • investigate women’s experiences of the interventions, identify the barriers and facilitators that affect adherence in the short and long term, to explain the process through which they influence adherence and to identify whether or not these differ between randomised groups.

A longitudinal, qualitative, two-tailed case study design 60 was employed, in which the tails were the biofeedback PFMT and basic PFMT trial groups. A detailed protocol has been published. 21 A sample of women from both groups took part in semistructured interviews. The two-tailed case study design complemented the trial design in its comparative focus, with the analysis set up to explore group differences. In this chapter, we will hereafter refer to groups rather than tails, in line with the terminology used in the trial. Case study design supports robust group comparison in a qualitative way; 61 therefore, conclusions of similarity and difference should be read as qualitative comparison as opposed to quantitative (statistical) comparison.

Sampling and recruitment

Forty randomised women (20 in each group) were purposively sampled for variance in centre type, women’s type of UI and therapist type. Each recruited woman was one case. Women were asked to consent to the case study specifically (having already consented to take part in the trial). The women were given an additional invitation letter [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/ (accessed 29 July 2019)] and patient information leaflet [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/ (accessed 29 July 2019)]. Women who remained interested were contacted by telephone approximately 1 week later to ask if they would like to participate. Written consent was obtained at the time of the first interview [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/ (accessed 29 July 2019)].

Case study data collection

Data were collected by a series of semistructured interviews [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/ (accessed 29 July 2019)]. Each interview had a specific focus:

  • Baseline pre-treatment interviews (face to face) explored the woman’s experience of UI, the social contexts within which she experienced UI and her expectations of treatment.
  • A 6-month post-treatment interview (face to face) explored the woman’s experience of the trial intervention, her adherence to therapy appointments and the prescribed programme, factors that affected that adherence and her perceptions of treatment outcome.
  • 12- and 24-month interviews (telephone) explored, at each time point, the woman’s experience of UI post intervention, the intervention, factors that influence ongoing PFMT adherence and treatment outcome.

Interview data were, with consent, collected using a password-protected audio digital recorder. Interview audio-recordings were anonymised, transcribed verbatim and entered into NVivo software to support analysis.

Case study data analysis

Analysis was guided by the OPAL trial protocol [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/ (accessed 29 July 2019)] and the OPAL qualitative study and process evaluation analysis plan [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/ (accessed 29 July 2019)]. Three different researchers have worked on the OPAL case study (Anne Taylor, Aileen Grant and Marija Kovandzic), alongside the responsible grant holders (Carol Bugge, Jean Hay-Smith and Sarah Dean). By the nature of qualitative analysis, each analyst had a different approach to data analysis. This was encouraged by the grant holders, within the confines of the protocol, to maximise the insights into the data. Sources that were drawn on to support that analysis included Yin, 60 , 61 Alvesson and Sköldberg, 62 Grant et al ., 63 Kovandžić et al ., 64 Stake 65 and Ritchie et al . 66

Overall, analysis was iterative with data collection. Analysis occurred on four interacting levels to facilitate within- and cross-case comparisons.

At the level of the individual interview

An initial a priori coding scheme was developed and initially applied, focusing on core areas of interest: UI experience, PFMT ± biofeedback experience, factors that influenced adherence in the short and long term and perceptions of treatment outcome. The coding was developed through team discussions, iterative coding and multiple analysts’ perceptions. The analytic purpose was to identify barriers and facilitators that influenced adherence and patient-reported UI outcomes.

At the level of the case (woman)

Case summaries in narrative and tabular form were written with a focus on understanding a woman’s experience of UI, the treatment, adherence, treatment outcome and how these factors interacted. Analysis focused on identifying issues relating to changes over time and in developing rival explanations (additional theoretical propositions) that guided subsequent analysis. 60 Theoretical propositions and rival explanations are analytic strategies drawn from case study design. 61 The theoretical propositions used in the OPAL trial were drawn from the original research questions and the rival explanations arose from working with the data.

At the level of the trial group

Using case summaries and matrices from the framework approach, 66 the cases for one trial group were arranged together and consistencies and inconsistencies searched for. The aim of analysis was to identify the core barriers and facilitators within the trial group, the detailed explanations for them and interactions between them.

At the group comparison level

The biofeedback PFMT and basic PFMT groups were compared using the theoretical propositions in order to identify similarities and differences in barriers and facilitators between the trial groups.

After the trial result was known, an additional analysis was undertaken that aimed to explore who biofeedback works for and why. This analysis is not presented in this report, but may be helpful in understanding subgroups of women for whom biofeedback is more useful.

Management and governance

Ethics approval for the case study was gained within the main trial approvals (see Chapter 2 ).

The case study and process evaluation team had a management group with the required mix of clinical, qualitative, quantitative and theoretical skills and experience. The group met regularly to discuss the research management and emerging findings. The case study was carried out at a separate academic institution to the main trial. The case study team participated in trial meetings to understand how the trial was progressing, but the case study and process evaluation team meetings were closed. Data were not shared from the case study and process evaluation group with the main trial group until the final PMG meeting in September 2018.

Forty women, 20 per group, were recruited to the case study, as planned. Twenty-five women completed all four interviews, but, owing to the technical problems with the audio-recorder, a full data set was available for only 24 women (10 biofeedback PFMT and 14 basic PFMT). The total data set consisted of 125 interviews, including 24 complete cases (96 interviews). The total number of minutes of recorded interviews per case ranged from 15 minutes to 126 minutes, with a total of 2856 minutes of recorded interview data. There were 40 baseline interviews (20 biofeedback PFMT and 20 basic PFMT), 32 interviews at 6 months (16 biofeedback PFMT and 16 basic PFMT), 28 interviews at 12 months (13 biofeedback PFMT and 15 basic PFMT) and 25 interviews at 24 months (11 biofeedback PFMT and 14 basic PFMT).

The age of women in the case study ranged from 20 to 76 years, with both the biofeedback PFMT and the basic PFMT groups including women with a wide age range ( Table 31 ). In the main trial, women ranged in age from 20 to 83 years (22–83 years in the biofeedback PFMT group and 20–78 years in the basic PFMT group); thus, the women in the case study were comparable in age to the main trial sample. From the total case study sample, 11 women had SUI and 29 MUI; the proportions were similar within groups. Six women in the sample were treated in community clinics, 16 in university hospitals and 18 in district general hospitals; again, there were similar proportions in the groups. The vast majority of women were treated by physiotherapists ( n  = 36) and four women were treated by nurses.

TABLE 31

Characteristics of women in the case study by group allocation

Women’s adherence to the interventions

Women’s adherence to the interventions was analysed in two phases: active treatment and maintenance. ‘Active treatment’ refers to the time when women were attending appointments and receiving the OPAL trial interventions delivered by a trained therapist. It is the proxy for shorter-term adherence – the uptake and adoption phase of PFMT – including women’s attendance at appointments, receiving biofeedback-mediated PFMT or basic PFMT in the clinic and then undertaking their prescribed programme (biofeedback PFMT or basic PFMT) at home between appointments. The ‘maintenance’ phase is when long-term adherence is demonstrated and is the period of time after the active treatment has ended when women were asked to continue PFMT themselves at home without therapist supervision, including relapse management, up to their final follow-up at 24 months.

Table 32 shows examples of the variation in women’s adherence to PFMT. These examples illustrate that there are no obvious group differences in adherence in the case study sample in terms of the frequency with which they undertook biofeedback PFMT or basic PFMT.

TABLE 32

Case study examples of variation in adherence to treatment by allocated treatment group and across time

Facilitators of adherence during the active treatment phase

There was greater similarity than difference in facilitators of adherence in the active treatment phase when the trial groups were compared. Two key themes, among the many that were identified, focused on UI symptoms and factors related to the OPAL trial therapist.

Urinary incontinence symptoms acted as a facilitator in several ways. One way was through the mechanism of women wanting to eliminate or reduce their UI, so that they could get on with their lives and improve their quality of life:

Case 27, 0M, biofeedback: Well I’m hoping that it’ll help the leaking and it’ll, it might never stop, but it won’t be as bad as it’s been . . . that’s what I’m hoping.
Researcher: Yeah. Is there a goal; do you have, like, a personal goal that you would like?
Case 27, 0M, biofeedback: Just that really, just . . . to stop the leaking, maybe be able to go back to yoga and not feel like I’m worrying about leaking or whatever.
I’m not that old that I, I’m ready to kind of hang up my dancing shoes. Case 26, 0M, basic

Women also wanted to prevent a deterioration in their UI symptoms and to avoid surgery. Seeing an improvement in UI during the active treatment phase motivated women to adhere because they felt that their treatment, and their skill to undertake the exercise, was working:

Doing the exercises [was most helpful about treatment] and noticing that there was a change, do you know what I mean? And then realising myself that that was, there had been a change . . . Case 24, 6M, basic

For women from both groups who had a break in their regular biofeedback PFMT or basic PFMT practice, a deterioration in symptoms (after a period of improvement) provided proof of PFMT effectiveness and acted as a facilitator to use the skills that they had learned to overcome the symptomatic deterioration.

Many women from both groups talked at length about the positive impact of the therapist. Women talked about their therapist as an important and credible source of information, as a motivator and as someone who taught them the exercise, lifestyle and behavioural skills needed to undertake biofeedback PFMT or basic PFMT (in line with theoretical model underlying the interventions). 17 All of these factors influenced adherence in the active treatment phase in both groups. However, possibly the most important element of the interventions in each trial group was the instruction on how to perform PFMEs, given by the therapist during the vaginal examination (digital assessment). Given the sensitivity of the topic, vaginal examination was not easy to talk about during the research interviews and, consequently, not an easy finding to capture in the analysis. Yet there was a consistent observation of the importance of the therapist-mediated vaginal feedback as being one of two distinctive and valuable forms of vaginal feedback in PFMT (therapist mediated and EMG mediated). The findings from the case study point to the therapist-mediated feedback as being the priority and as one of the most important therapist-related facilitators in gaining confidence in PFMT skills and adhering to treatment.

The quotation below provides an illustration of the difficulties of articulating experience of PFME instructions during the vaginal examination, as well as the importance of these instructions, which included feedback (as exemplified in the quotation, a part of the feedback loop was the act of the therapist feeling the difference in muscular activity during the examination):

That was quite good actually, having somebody there, and I think when you’re doing exercises and then being able tae feel that it was working, do you know that way when you would get your assessment . . . and you did have to do them, the exercises, and she could feel the, the difference [ . . . ] I felt [ . . . ] that was good, u-uuh, just to know that you were doing it properly [ . . . ] ’cause you do those exercises and you really don’t know one way or another if you are doing it right. Case 30, 6M, biofeedback

Another important therapist-related factor that had an impact on adherence was the rapport created between the therapist and the woman. The conditions for creating rapport require further analysis. It is possible that the above-mentioned therapist-mediated vaginal feedback plays a role, but at this point of analysis it is certain that having dedicated space and time (secured by OPAL trial intervention design) to build understanding and trust through repeated appointments with the same therapist acted as a motivator to adhere to the treatment, if not being a therapeutic agent on its own:

And it’s very motivating . . . you know, seeing someone who’s interested in you, who wants to help you is terribly motivating . . . ‘cause otherwise you’re just on your own, ‘cause you don’t chat to your friends about it . . . the only person I’ve ever really spoken to about this [UI] is [OPAL therapist] and the nurse specialist. Case 32, 6M, biofeedback
[ . . . ] it was good having a one to one with someone who kind of constantly, you were able to talk to about your symptoms and how to improve it and I think just knowing that em that they were there and they were able to tell you, you know, ‘if you work on this, it will improve’ and I think that was a big help, even right at the end there, it was a really good for her to tell me, the physio[therapist] to tell me, like, what exercises it’s best for you to do, what’s not good for you to do and if you keep going wi’ this it’s going to continue to improve, I think that will help me. [ . . . ] you know, psychologically, even if it wasn’t physically, you know, I mean it eventually will be physically, but em, you know, even psychologically I think that was good. Case 15, 6M, basic

Other therapist-related facilitators included education provided by the therapist, being treated by an accommodating and skilful therapist, being treated by a therapist who adjusted the treatment protocol based on individual needs and feeling accountable to the therapist:

I think it was the, the, eh what’s the, what’s the best way to describe it, the actual having to report back to [therapist], because then you knew, you know, you can’t, well you can’t just sort of, you know, sit there and say ‘right, OK I didn’t do it,’ and she would know herself when we did the sort of, the few, even, you know, not the internal examination, when we did the actual work, you know, when she was there and she could tell from my posture, you know, if I was doing it right or not, she was like ‘right, you’re slacking’ . . . Case 3, 24M, basic

Beyond the symptom- and therapist-related facilitators summarised above, women identified other facilitators of adherence that included the following:

  • Service structure, framing and physical environment. Having regular appointments; ease and flexibility of making appointments; feeling positive about the physical environment of the treatment facilities; feeling that the intervention was within the framework of womanhood; or the woman finding the treatment as a whole a novelty were all facilitators of adherence.
I was so determined though, I mean the thing is you’ve got to want to, to help yourself I think [ . . . ] you know, it’s just not going to, just taking a note of what somebody says to do, you’ve got to want to do it as well [ . . . ] you’ve got to want to, you’ve got to need to do it as well, you know. Case 20, 24M, basic
  • Support from relevant others. Their partner, participation in the trial and a sense of accountability to the trial team were all facilitators of adherence.
. . . so the education was eh the principal thing, when you learn how to do and why it’s wrong, what is wrong . . . and then you can do your, do good for your body. Case 13, 6M, biofeedback
. . . it’s probably the easiest form o’ exercise you could do, I mean you don’t even need tae go tae a gym, it’s so easy. Case 34, 12M, basic

There were facilitators that were specific to biofeedback. Some women reported liking the biofeedback device and having confidence that, by using biofeedback PFMT, they were more likely to achieve symptomatic improvement than if they were doing PFMT alone. In developing the OPAL trial intervention, the research team hypothesised that visualisation of the pelvic floor muscle contraction via biofeedback PFMT would support self-efficacy for performing the correct contraction, leading to improved adherence and better outcomes. Some women in the biofeedback PFMT group did report that visualisation was important for them for two main reasons: (1) they could see if they were doing the pelvic floor muscle contraction correctly and (2) they could see improvement in their pelvic floor muscle contraction ability over time. Women valued the opportunity to be able to discuss the visualised contraction with their therapist.

Other features of biofeedback PFMT that women valued were biofeedback supporting women being competitive with themselves; having a new ‘toy’ to play with; the physical presence of the unit acting as a reminder; getting instruction from the biofeedback device in terms of counting of repetitions and pace of PFMT; and an awareness that the data on the biofeedback device would be looked at by and discussed with the therapist:

I thought it was quite positive that when you were actually using it you could see, and I think it did make you try, it definitely made me try harder, and also I felt that I was doing it for longer, like it, you know, a 10-second hold I think when you haven’t got the biofeedback is probably, in reality, an 8-second hold, because you count quite quickly . . . whereas with the biofeedback I felt that you were doing it properly and I was definitely trying harder because I was seeing it and I was thinking ‘right, I want’ it’s that sort of slightly competitive side to human nature, you’re thinking ‘right, I want to get, I want to get it higher’. Case 8, 6M, biofeedback

In summary, although some group differences were noted, there were more similarities in facilitators of adherence than differences. There were many facilitators of adherence in the active treatment phase, with being motivated to improve symptoms and the effect of the therapist being clear facilitators in both groups.

Barriers to intervention adherence during active treatment phase

There were more similarities across barriers than there were differences between the groups. Time and contextual factors in a woman’s life (such as daily routines) were two of the themes that could be seen to act as barriers to adherence.

Women talked about having a lack of time for themselves; hence, finding time for appointments and to exercise was difficult. Women reported a lack of time to attend appointments in general and frequent appointments in particular, to focus on practising PFMT, either with or without biofeedback; biofeedback was even more time-demanding and, as such, a potentially greater barrier in the biofeedback group:

I don’t know who supplied the physio[therapist] with the dates, but she kinda had a calendar, at the end o’ my appointment she could tell me the time frame when I was due back . . . and I would look at my diary and was like ‘oh, that’s only like 2 weeks’ time’, so I don’t know, maybe even once every 5, 6 weeks or something, em but that, again, that’s just because I’m a working mum and I don’t always have the child care, so em it wasn’t always easy for me to, to get the kids watched, . . . Case 16, 6M, biofeedback

Lack of time was compounded by having a generally busy life that included being a working mother, having unpredictable work patterns and going on holiday. For several women, their UI, and its treatment, was not a priority given the array of other things that were competing for their time. Illness – theirs, or in family members – was a particular barrier to adherence:

Em . . . most of the time I’m OK now, as I say I still do my pelvic floor exercise at the moment, eh it’s not always OK, but [most of them are?], em [sighs] that’s nothing to do wi’ the machine [?] that I dropped out [of treatment], I took, mum took no’ well and I took really bad depression and I would’nae get out the bed. Case 17, 6M, biofeedback

Other contextual factors that acted to diminish adherence included not having a routine (or hook) for doing PFMT, lack of privacy at home, lack of support from their partner and simply forgetting (in the array of other things to do).

Several other barriers could also be identified, these included the following:

  • A lack of sufficient, or sufficiently quick, improvement in the UI symptoms. This led to a drop in motivation to adhere. Despite this drop in motivation, many women were still inclined to continue treatment.
Yeah, there seemed to be quite a lot, you know, I seemed to have a lot of appointments, em . . . my husband’s going ‘oh you’re not going there again, what are you going for, what on earth are you going for this time?’ . . . Em maybe the odd time I did feel a bit like that ‘cause I felt, u-uuh, at times I thought ‘oh God here, we’re just going to talk about exercises’ [ . . . ] the odd time I did feel ‘gosh, maybe that was a bit of a waste of time’ [slight laugh] . . . Case 15, 6M, basic
I thought there would be, I thought there would maybe be more em involved in helping support you doing the actual . . . exercises; not that they were difficult or anything like that, I just, I, I think I just felt, you know, you get told what to do, you’re advised about what, how to do them, they don’t, [sighs] I’ve only once been checked to make sure I was doing them right, em so my feeling kinda was am I doing these right? Are they really effective?, and it was a bit hit and miss I felt . . . to how well I was doing; . . . Case 26, 6M, basic

There were some barriers that were specific to the biofeedback PFMT group. Some women found the biofeedback device intrusive or painful to use and others found it inconvenient (e.g. having to set it up, or to clean it):

I found it intrusive and painful to be honest [ . . . ] if I had of [sic] found it less uncomfortable it possibly would have made me notice what I was doing more, but I, I just couldn’t put up [with] the, the pain of it, so I couldn’t be bothered with it. Case 5, 24M, biofeedback

Women reported that they needed to find even more time to undertake PFMT supported by biofeedback. Some women also reported embarrassment and a lack of privacy about using biofeedback:

I think it was quite a good idea, but I don’t think it worked for me, for my personal circumstances, I found it too footery [fiddly] to do, and I just found it quite difficult to have that kind of privacy . . . just to do it, because I found it easier if I was lying down in the bedroom but then, you know, the kids were always like in and out, running around and obviously I didn’t want them to see it, and I just felt it took quite a lot of time and I just felt I didn’t really have the privacy to do it properly, em, so I don’t think it really worked for me, I felt it was too footery; but on the other hand I think it had lots of advantages, ‘cause I think it was quite useful to see, to see what was actually happening. Case 8, 24M, biofeedback

Other issues with the biofeedback included one woman reporting that she got thrush from using the biofeedback unit; the biofeedback unit could be framed as externalising the movement of the pelvic floor muscles and a distraction to embodiment of PFMT; and practical problems with the biofeedback unit that hampered ability to use it:

I thought I was doing super, then one day it died and it, I knew it had a brand new battery so that shouldn’t have happened . . . it died, so I rang them up and I took it in and we got a new battery, then I came back and it happened again, it kept doing weird things, and then I bought batteries up the road in the end, so, . . . And then I realised that by looking at the machine I was distracted from doing the exercises. Case 32, 6M, biofeedback

In summary, there were more similarities than differences in barriers to adherence in the active treatment phase; there were also additional barriers in the biofeedback PFMT group. A lack of time and many contextual factors were the key barriers to adherence to biofeedback PFMT and basic PFMT.

Facilitators of women’s adherence in the maintenance phase

None of the women in the biofeedback PFMT group reported using biofeedback after the end of treatment in the trial. None of the interviewed women reported buying biofeedback equipment; some therapists did give women the probe to keep and use, yet none of the women reported using it, even though some reported intention to use it. Thus, the data below relate to women, from both groups, undertaking basic PFMT in the maintenance phase.

Women in both groups reported a change in their adherence from the active treatment phase. PFMT maintenance was not consistent over time in either group and there were no differences (from qualitative comparison) between the groups in their adherence. The inconsistency in adherence between women can be seen in Table 32 , in which, at the extremes, some women undertook PFMT in a regular and daily manner, whereas others did not do PFMT at all. In between these extremes were women who undertook PFMT with varying degrees of regularity. As well as the inconsistency between different women, there were fluctuations in adherence for individual women over the time period with, for example, other health concerns taking over and diminishing adherence at some points in time.

Many of the facilitators that applied when women were in the active phase of treatment also applied in the maintenance phase.

Similar to the active treatment phase, women’s desire to lessen UI symptoms supported adherence to PFMT in the maintenance phase. If women perceived symptom deterioration or recurrence and associated this with PFMT as a mechanism to improve symptoms, adherence was facilitated. The interpretation of the data would suggest that symptoms may only act as a prompt to undertake PFMT in the maintenance phase if the woman perceived that there was an improvement in symptoms as a consequence of doing PFMT during the active treatment:

Not really no [been doing PFMT], but quite often in the last week, ‘cause I’ve noticed a difference that’s why I’ve sort of started to try and do it again, ‘cause I have noticed a difference in not doing it . . . Case 8, 6M, biofeedback
Oh yes, I always will [exercise] now, that’s it . . . that’s it, because I know it, I know it’s, you know how much it’s helped. Case 20, 24M, basic

There were multiple factors that seemed to influence women’s confidence (self-efficacy) to continue, or feel able to restart, PFMT in the maintenance phase. Many women reported feeling that they had good levels of knowledge and skill to undertake PFMT correctly. Beliefs in their skills and knowledge could be attributed to women feeling they had mastery of PFMT; having memories of the support they received from the therapist during active treatment; recalling information imparted by the therapist; using the resources given by the therapist (such as information leaflets); keeping a record of PFMT like an exercise diary; and recalling the sense of hope given during treatment and the control they gained:

I don’t feel like I need to go back and see a doctor or, you know, see a nurse or anything, I feel like if it got bad again I could, you know, I’ve got these exercises to fall back on. Case 27, 24M, biofeedback
I remember the girl who, or the nurse that, the lady, you know the . . . pelvic floor . . . in [location], and I remember her, she was very good, gave me a lot of confidence in myself, you know and . . . it was really good, she was very, very helpful, and I can remember, I can remember the improvement, . . . Case 20, 24M, basic

In the biofeedback PFMT group some women related having good skills and knowledge of PFMT directly to biofeedback during active treatment. Women in the basic group also felt that they had good skills and knowledge of PFMT acquired from teaching by, and feedback from, therapists. Therefore, biofeedback was not a necessary prerequisite for having skills and knowledge for PFMT maintenance:

[I remember] learning to use the machine properly . . . knowing I was doing it right and . . . yeah, and just generally being made more aware of the muscles that you need to squeeze and . . . when you’re, and you know you do one at a time and then you hold them all . . . so yeah . . . being taught how to do pelvic floor . . . muscle training . . . yeah, being taught that properly, yeah, . . . made a big difference. Case 23, 24M, biofeedback

Other factors that facilitated adherence in the maintenance phase included the following:

  • A supportive home environment.
  • Establishing the intervention as part of life: being able to find time for themselves; helpful work patterns (e.g. working from home or time spent commuting); making use of available time to do exercises (e.g. sitting and waiting time such as while commuting, or watching television).
I don’t think so, I mean I know what to do, I mean it’s . . . I, I, aye, I know what tae dae and I know what I should be doing but it’s just the getting intae it, so . . . maybe I should start up a wee book kinda thing again, I done that the last time and I was dain’ wee [unclear word] like when, how many I had done, do you know, how many kinda exercises I’d done that day, and eh, do you know what I mean, I think I should start that, when it’s doon in black and white sometimes that kinda, kinda motivates you oan . . . Case 24, 12M, basic
Oh probably [doing PFMT] daily, ‘cause I do sort o’ try to keep it going . . . ‘cause I’ve got to keep control o’ something, I can’nae control everything else [that I’ve got?] . . . [I was more?] conscious of it then, but, as I said, it’s one thing I’m sort of trying to keep control of . . . so I’ll try and keep that bit going. Case 17, 24M, biofeedback
  • Trial-specific factors – research interviews acting as a trigger to undertake PFMT, interviews providing a space for reflection on a woman’s own PFMT practice, attending the 6-month pelvic floor assessment and wanting to demonstrate that the therapist had done an excellent job. These factors occurred in both groups.
I [got] the squeeze App on my phone and that was really good . . . you know, it helps you, you obviously train yourself to hold for longer [kind of thing], that was good. Case 19, 24M, basic

In summary, adherence did change in the maintenance phase from the active treatment phase. There was considerable variance, in individual women and between women, in adherence in the longer term. Many of the facilitators that supported women in adhering in the active treatment phase continued to facilitate adherence in the maintenance phase.

Barriers to women’s adherence in the maintenance phase

One barrier to adherence that was unique to the maintenance phase was the loss of therapist support, and accountability to the therapist, when the active treatment phase ended. Some women felt ‘alone’ in their efforts to improve their UI. Others expressed the view that, because they were no longer accountable to the therapist, there was no longer that prompt to exercise. Other women said that they got out of the habit of writing their exercises down (as they would have done in the exercise diary during active treatment):

I thought, you know when the nurse did it with me, you know, did it, that helped me a lot, really it did, if I could keep going to the physiotherapist and if she kept checking me, because I think, you think you’re doing it right and then I could be doing it wrong and that, you know what I mean, I mightn’t be feeling . . . Yeah, I mean I would have liked then to be able to phone up, you know, the physio[therapist] and say ‘look, can I have another appointment?’, rather than the length of time between each, and then of course it stopped for so many months . . . Case 6, 12M, basic

Otherwise, the main barriers for women in maintaining PFMT, whether allocated to the biofeedback PFMT or basic PFMT group, were similar to those found in the active treatment phase. First, some women’s UI had improved to such an extent that they had no symptoms to act as a reminder to exercise:

. . . as I said my symptoms have reduced so there’s not so much of a physical reminder that ‘oh, I need to do them’ [PFMT]. Case 28, 12M, biofeedback

The second key barrier was the loss of motivation or loss of the habit of doing PFMT due to life events taking over, even if this was contrary to the intent they had at the end of active treatment. Women spoke of various contextual factors in their lives that prevented them from maintaining a PFMT regime, such as having too many other things to do, work commitments or work changes getting in the way, or more generally feeling that they lacked support. Commonly, women talked of having other non-UI health problems that overshadowed their focus on UI and/or on their attention being more on the needs of others (commonly immediate family). In keeping with the active treatment phase, the findings suggest an interaction between a lack of time (e.g. as shown below, women not having time for themselves) and the multiple other contextual factors that get in the way of life:

Well I’ve had a lot o’ other health issues so it’s kinda been, that’s [PFMT] been the least o’ my worries [UI] tae be honest wi’ yae [slight laugh]. Case 10, 24M, basic
Case 32, 12M, biofeedback: . . . it really is down to me . . . I expect you hear that from a lot of women . . . And it’s very hard to put yourself at the top of your own time agenda . . .
Researcher: As women . . .
Case 32, 12M, biofeedback: Yeah, yeah [talks about her husband exercising every day no matter what] . . . So, but with me something seems to come up, [then it’s?] all my stuff goes to pot on my own agenda . . ., I suppose it’s just, [he’s] not easily distracted but there are more pressures on me . . . and I think it’s probably the same for women generally.

Other factors that acted as barriers to adherence in the maintenance phase were as follows:

  • Not establishing PFMT as part of life. Some women found maintaining a PFMT exercise programme to be difficult because they had no routine in life generally, or for PFMT specifically, or that routine changed (e.g. going on holiday).
  • Not feeling confident in their PFMT technique and when to use it after treatment had stopped. This seemed to manifest as a lack of confidence in (1) their ability to undertake PFMT generally or (2) how to get restarted after a break in PFMT. Various reasons can be identified for this lack of confidence in the maintenance phase: forgetting what they were taught, not feeling that PFMT was going to work, not perceiving that their UI was caused by pelvic floor weakness (it was caused by something else) or because they had not seen symptomatic improvement during active treatment. However, there was a stronger pattern for women to feel confident about continuing PFMT than not having the confidence to continue.
  • Ownership and agency in PFMT. Some women talked about a lack of motivation and willpower, they talked about forgetting to exercise (sometimes or always), and PFMT lost the novelty factor and priority over time.

In summary, large-scale systematic differences between the biofeedback PFMT and basic PFMT groups in barriers to PFMT maintenance were not evident from the data set. Key barriers to maintaining PFMT lay in loss of support following the active treatment phase and busy lives.

Women’s urinary incontinence outcomes in the short and long term

The case study did not set out to explore outcome, but women discussed outcome as part of their experience. Given the longitudinal case study design, and the core aim of the trial, it was useful to consider women’s views of outcome in this chapter in relation to UI symptoms. However, interviewed women reported outcomes that were considerably broader than UI symptoms alone. For example, the women talked about changes they made to their lifestyle, changes to their feelings about UI and about a myriad of things they had learned from being part of the trial. These additional outcomes will be documented in more detail in future publications.

At 24 months (when the primary outcome was measured in the trial) there was no obvious difference between the groups in UI severity from qualitative comparison; rather, there were women in both groups with varying outcomes ( Table 33 ).

TABLE 33

Case study examples of variance in UI outcomes at 24 months by allocated treatment group

In both the biofeedback PFMT and basic PFMT groups there were more women talking about positive outcomes in relation to their UI symptoms at 24 months than there were talking about poor outcomes (i.e. from baseline it seemed as if women tended to be better than they were before they entered the trial). This information, however, needs to be considered with caution, as qualitative studies do not aim to statistically generalise:

I was just going to say well no, thank you for the opportunity because I’ve seen a massive, you know, improvement and because I’ve got a prolapse and obviously, I’m quite young, I’m only 38, it was making me sort of anxious about [?] and you know, everything has improved, my bladder control and my prolapse symptoms have improved, I’m not getting as many em, I used to get sort of quite a lot of dragging sort of tummy ache [muscle, or little,?] and I don’t get that any more, so, you know, and I know that that is definitely all down to the trial, if I wouldn’t have been involved in that, then I know that I’d still be having the problems and still be anxious, you know, if I went out walking or if I went, went running, or to the gym or whatever, so, so I’d like to say thank you to you guys as well. Case 28, 24M, biofeedback

In terms of short-term outcomes, in both groups there was a pattern that suggested that women were likely to have better UI outcomes at 6 months (immediately post-active treatment phase) than at 24 months. For example, case 13 (biofeedback PFMT) reported symptomatic improvement at 6 and 12 months, but at 24 months reported that her symptoms were the same or a little worse than when she started the trial. There was, however, variance between individuals. For example, for case 32 (biofeedback PFMT), there was no improvement noted at 6 months and at 24 months her symptoms were worse than when she started the trial. There were other cases when improvements occurred beyond 6 months (i.e. 6 months was not the best outcome point). For example, case 36 (basic PFMT) reported good improvement at 6 months, further improvement at 12 months and yet further improvement at 24 months.

In summary, there were no obvious differences in UI outcome between the trial groups.

Theoretical propositions

Two theoretical propositions and one rival explanation were considered. The theoretical propositions were driven by the theory that supported the hypothesised mechanism of action (propositions 1 and 2) and one rival explanation that arose from analysis of the data (proposition 3).

Proposition 1: biofeedback PFMT will improve (1) women’s adherence and (2) women’s urinary incontinence outcomes more than basic PFMT in the short and long term

This proposition was the main hypothesis of the trial. There was no clear evidence that biofeedback PFMT improved adherence over basic PFMT in the short or long term, nor any clear evidence of greater improvement of outcomes in either the short or the long term. Therefore, the theoretical proposition was not supported.

Proposition 2: the factors that influence women’s adherence and women’s urinary incontinence outcomes change over time

This proposition arose from the long-term nature of the follow-up that was part of the commissioning brief and was based in our understanding of the influence of context (e.g. Wells et al. 67 ). This proposition was supported in that it was clear that the factors that influence adherence and outcome for an individual woman do change over time. For example, there were women who were diagnosed with other conditions during the trial that, for them, took precedence in their quest for good health. However, the hypothesis aimed to identify if there were factors that arose at specific time points for a group of women. It does not seem that there were factors that occurred at the same time point in specific groups of women (other than the removal of support when treatment finished); however, this will be the subject of further analysis.

Proposition 3: factors other than biofeedback PFMT or basic PFMT will influence adherence and urinary incontinence outcome in the short and long term

This proposition arose from rival explanations (to biofeedback PFMT or basic PFMT directly linking to adherence and outcome) being identified iteratively in data analysis. Although there were factors other than the interventions that influenced adherence and outcome, there were considerably more similarities in the factors than differences between the groups. The notion of life events taking over encapsulates this well. However, for some women with multiple other life events, there was still adherence and a symptomatic improvement (i.e. these factors did not always act to diminish adherence or outcome, but they often did).

Women reported positive experiences of both the biofeedback PFMT and basic PFMT interventions; in particular, women were clear about the benefit of therapist input. There were no major differences, based on qualitative comparison, in adherence to PFMT or UI outcome between the biofeedback PFMT and basic PFMT groups, with wide variation in adherence and outcome in both groups. Adherence in the short and long term was facilitated by women’s desire to improve or cure their UI symptoms and by factors related to the therapists, which included feedback given through vaginal examination and rapport. A lack of time and life taking over were key barriers to adherence in both the short and long term. Adherence did change over time, but there were no clear differences between the groups. Although UI outcome did not appear to differ between the groups, there was a trend towards improved outcomes at 2 years when compared with baseline. There were features of biofeedback PFMT that worked as anticipated (such as visualisation), but there were also drawbacks to biofeedback (such as it taking more time than PFMT alone).

Strengths and limitations of the case study

A key strength of the case study, and qualitative research linked to trials in general, is that it facilitated the voice of those whom the intervention aimed to help to be heard and represented. The longitudinal nature of the case study, with detailed follow-up at the same time points as the trial, and the purposeful searching for expansion on emerging ideas at subsequent interviews, allowed consideration of women’s expressions of adherence to PFMT over time. Studies of long-term adherence in UI are rare (only one other longitudinal study, 68 with women who have UI, has been identified), but are important as reduced adherence is a common explanation for why treatment effect is not sustained over time. 69 The two-tailed case study design offers a robust, qualitative means of comparison that supports the comparison in the trial.

The process evaluation and case study drew on a contemporary published framework in further developing the work and developing the analysis plan. 63 That framework proposes multiple candidate approaches to understanding various features of the trial and its effects. However, one weakness was that data were not gathered on all the candidate approaches. 63 However, data were gathered on several candidate approaches that were central to the research questions, such as maintenance. Another potential weakness of the case study in relation to the trial is that the interviews may have acted as a co-intervention to promote adherence, for example women reflected that they undertook PFMT because they knew that an interview was coming up. However, the case study recruited women from both the biofeedback PFMT and basic PFMT groups and any effect of the interviews on adherence potentially occurred equally in both groups.

Comparison of findings to existing literature

The evidence from the case study is consistent with the trial finding that biofeedback PFMT did not improve UI outcomes more than basic PFMT. Insights from the case study are helpful in explaining the main trial finding. The qualitative data demonstrated that biofeedback could work as anticipated, with women reporting the benefits of being able to visualise the contraction and know that they were doing the contraction correctly, alongside their learning in partnership with the therapist. However, women in the basic PFMT group also had confidence in their ability to undertake PFMT. For these women, this was based on learning in partnership with the therapist. A possible conclusion is, therefore, that biofeedback does not need to be added to a strong basic PFMT programme in order for women to achieve self-efficacy for and adherence to PFMT; good therapist input can also provide self-efficacy and adherence.

Aspects that are central to this conclusion are that the OPAL trial basic PFMT (and biofeedback PFMT) programmes allowed sufficient time with therapists to support a treatment effect; 70 both interventions were based on BCTs; 8 both demonstrated that some women achieved self-efficacy for PFMT; 71 both groups received therapist-mediated vaginal feedback; and one group also received biofeedback. 7 Although it is possible that if biofeedback PFMT had been compared with a less robust basic PFMT programme there would have be been a difference between groups, it would then have been difficult to reach conclusions about the effectiveness of adding biofeedback because of other confounding variables. 7 Our conclusions therefore support a finding that, if all other aspects of PFMT are kept equal, the addition of biofeedback may not lead to a greater improvement in continence outcomes.

Another possible explanation for why biofeedback PFMT was not more effective than the basic PFMT is that, although women in the biofeedback PFMT group did identify features of biofeedback as facilitators of adherence, they also identified features of biofeedback as barriers to adherence. One tentative hypothesis here is that the facilitators and barriers simply cancel one another out. However, this needs further analysis.

Case study findings demonstrated that women generally reported positive experiences of the OPAL trial interventions. Women were positive about learning to do PFMT (with or without biofeedback), which is consistent with a previous qualitative synthesis. 18 Women were also very positive about the therapists. Women talked about the therapist in ways that suggested that the therapist was seen as a credible source of information, a motivator and as someone who could support the learning of the necessary behavioural skills, all of which supports the theory underlying the development of the interventions (IMB 17 ). Furthermore, in keeping with previous suggestions, rapport between woman and therapist was seen as a factor in supporting adherence. 18

There was a trend identified in the case study data for women to perceive that their UI was better at 2 years than it was when they started the trial. This was not the case for all women. It was, however, an important finding in the context of the worldwide evidence that UI negatively affects women’s day-to-day lives (see, for example, Bradway, 72 Delarmelindo Rde et al. 73 and Hamid et al. 74 ). Although it is possible that the improvement described by women is not linked to the interventions, the evidence suggests that women did perceive a link between the intervention they received, their adherence to PFMT and their positive outcome. This link will be explored in more detail in further analysis.

Adherence to PFMT did change over time, but not differently between the allocated groups. A key reason for including the case study alongside the trial was the recognition of the influence of context on the effectiveness of complex interventions. 67 , 75 It is now widely recognised that context interacts, modifies, shapes and constrains the intervention and implementation. 76 This study chose to investigate the influence of context in-depth from the participants’ perspectives (rather than also exploring the problem, trial and organisational contexts), because it was believed these would be the most important factors to shape the interventions and influence their effectiveness. It is important to understand the dynamic relationship between context, implementation and intervention to define what was implemented and understand how works in certain contexts. It is now no longer enough to say what works, we need to explore what works, for whom and in what context. 53 It was clear that many varied personal contextual factors influenced adherence. The longitudinal nature of the study was important in highlighting that for all women, context and implementation were dynamic and life events got in the way. In addition, many women put the needs of others before themselves. We need to carry out a nuanced analysis to explore the characteristics of these women to understand the various ways women may overcome these events. Previous research supports the links between life taking over and inconsistent adherence in UI. 57 , 77 These findings suggest that when delivering a PFMT intervention, or in future research, consideration should be given to helping women balance the multiple contextual factors in ways that may support their engagement with PFMT and their re-engagement with PFMT after a break.

Urinary incontinence symptoms were an important factor in adherence at the outset, and continued to be so in the long term. Symptoms influenced adherence in a number of ways. Women adhered to rid themselves of symptoms, but, conversely, when symptoms were no longer present, the trigger to exercise was no longer there and some women then stopped exercising. Women had to perceive change and believe that it was linked to treatment to maintain adherence in the longer term. This finding is consistent with other studies. 18 It is an important feature of care delivery for therapists to keep the connection between PFMT and symptomatic improvement at the forefront of women’s minds.

  • Cite this Page Hagen S, Bugge C, Dean SG, et al. Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT. Southampton (UK): NIHR Journals Library; 2020 Dec. (Health Technology Assessment, No. 24.70.) Chapter 6, Longitudinal qualitative case study.
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Qualitative research on software development: a longitudinal case study methodology

  • Published: 05 January 2011
  • Volume 16 , pages 430–459, ( 2011 )

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longitudinal case study qualitative research

  • Laurie McLeod 1 ,
  • Stephen G. MacDonell 1 &
  • Bill Doolin 1  

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This paper reports the use of a qualitative methodology for conducting longitudinal case study research on software development. We provide a detailed description and explanation of appropriate methods of qualitative data collection and analysis that can be utilized by other researchers in the software engineering field. Our aim is to illustrate the utility of longitudinal case study research, as a complement to existing methodologies for studying software development, so as to enable the community to develop a fuller and richer understanding of this complex, multi-dimensional phenomenon. We discuss the insights gained and lessons learned from applying a longitudinal qualitative approach to an empirical case study of a software development project in a large multi-national organization. We evaluate the methodology used to emphasize its strengths and to address the criticisms traditionally made of qualitative research.

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Acknowledgments

This research was funded through a Top Achiever Doctoral Scholarship by the Tertiary Education Commission of New Zealand. We would like to acknowledge the support of AlphaCo and SoftCo.

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McLeod, L., MacDonell, S.G. & Doolin, B. Qualitative research on software development: a longitudinal case study methodology. Empir Software Eng 16 , 430–459 (2011). https://doi.org/10.1007/s10664-010-9153-5

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Barriers and enablers for externally and internally driven implementation processes in healthcare: a qualitative cross-case study

  • Hilda Bø Lyng 1 ,
  • Eline Ree 1 ,
  • Torunn Strømme 1 ,
  • Terese Johannessen 2 ,
  • Ingunn Aase 1 ,
  • Berit Ullebust 3 ,
  • Line Hurup Thomsen 4 ,
  • Elisabeth Holen-Rabbersvik 2 , 5 ,
  • Lene Schibevaag 1 ,
  • David W. Bates 6 &
  • Siri Wiig 1  

BMC Health Services Research volume  24 , Article number:  528 ( 2024 ) Cite this article

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Quality in healthcare is a subject in need of continuous attention. Quality improvement (QI) programmes with the purpose of increasing service quality are therefore of priority for healthcare leaders and governments. This study explores the implementation process of two different QI programmes, one externally driven implementation and one internally driven, in Norwegian nursing homes and home care services. The aim for the study was to identify enablers and barriers for externally and internally driven implementation processes in nursing homes and homecare services, and furthermore to explore if identified enablers and barriers are different or similar across the different implementation processes.

This study is based on an exploratory qualitative methodology. The empirical data was collected through the ‘Improving Quality and Safety in Primary Care – Implementing a Leadership Intervention in Nursing Homes and Homecare’ (SAFE-LEAD) project. The SAFE-LEAD project is a multiple case study of two different QI programmes in primary care in Norway. A large externally driven implementation process was supplemented with a tracer project involving an internally driven implementation process to identify differences and similarities. The empirical data was inductively analysed in accordance with grounded theory.

Enablers for both external and internal implementation processes were found to be technology and tools, dedication, and ownership. Other more implementation process specific enablers entailed continuous learning, simulation training, knowledge sharing, perceived relevance, dedication, ownership, technology and tools, a systematic approach and coordination. Only workload was identified as coincident barriers across both externally and internally implementation processes. Implementation process specific barriers included turnover, coping with given responsibilities, staff variety, challenges in coordination, technology and tools, standardizations not aligned with work, extensive documentation, lack of knowledge sharing.

This study provides understanding that some enablers and barriers are present in both externally and internally driven implementation processes, while other are more implementation process specific. Dedication, engagement, technology and tools are coinciding enablers which can be drawn upon in different implementation processes, while workload acted as the main barrier in both externally and internally driven implementation processes. This means that some enablers and barriers can be expected in implementation of QI programmes in nursing homes and home care services, while others require contextual understanding of their setting and work.

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Quality in healthcare services is a subject in need of continuous attention [ 1 ]. Quality improvement (QI) programmes with the purpose of increasing service quality are therefore of priority for healthcare leaders and governments [ 2 , 3 , 4 ]. Nevertheless, despite the number of initiatives and QI programmes aiming to increase quality of care, quality of healthcare has still not improved correspondingly [ 5 ].

Programmes for QI usually involve the translation of new knowledge into practice alongside the following implementation and adoption, which is not a straightforward process [ 6 ]. Cresswell et al. [ 7 ] found implementation processes to be associated with four different contextual factors: technical aspects, social aspects, organizational aspects, and wider socio-political aspects, all influential for the implementation efficiency. This means that to ensure successful implementation, understanding the context specificity, where enablers and barriers for one type of setting not necessarily provide the same type of impact in a different setting, is important [ 6 , 8 ]. This leads to a need for adapting implementation processes to the situational context [ 9 , 10 ].

Studies on implementation of QI programmes are still scarce in nursing homes and home care settings. Equally, there is a gap in research concerning similarities and differences of different types of implementation processes, like internally and externally initiated implementation processes. Calls have therefore been raised in literature for future studies to explore contextual aspects in terms of specific types of implementation processes [ 11 , 12 , 13 ].

Implementation science has gained increasing focus in health service research, due to the need for understanding the critical role of implementation processes for QI. However, overlapping theories of implementation as well as ambiguous definitions and terminology still challenge the implementation research field [ 14 ]. To integrate important contributions, Damschroder et al. [ 14 ] in a meta-analysis, proposed five key elements for implementation; Characteristics of the actual intervention/ QI programme, Outer context, Inner context, Individuals involved, and the Implementation process. In a systematic review of barriers and enablers for the implementation of interventions in primary care, Lau et al. [ 11 ] presented a conceptual framework displaying influencing key factors for different levels of the implementation process: Intervention/ QI programme factors, Professional factors, Organizational factors, and External context. The understandings provided by Damschroder et al. [ 14 ] and Lau et al. [ 11 ] display similarities between these frameworks, and their relatedness for this study will be further discussed in terms of the inductive findings of this study in the context of two different implementation processes taking place in nursing homes and homecare services in Norway.

Aim and research question

This study aims to contribute understanding of two different implementation processes in Norwegian nursing homes and home care services. The first implementation setting (external case) refers to an externally driven implementation process where a researcher group facilitated meetings, material, assignments, monitoring of the process, and follow up. The second implementation setting (internal case) refers to an internally driven implementation process, where the organization itself had decided to implement a specific QI programme, and where the organization was responsible for the full implementation process. The following research questions guided the study:

What type of enablers and barriers are found important for implementation processes in nursing homes and home care services?

And secondly, are identified enablers and barriers different or similar across externally and internally driven implementation processes?

Based on the exploratory nature of the aim and research questions, we opted for a qualitative methodology [ 15 ]. The empirical data were collected through the ‘Improving Quality and Safety in Primary Care – Implementing a Leadership Intervention in Nursing Homes and Homecare’ (SAFE-LEAD) project. The SAFE-LEAD project is a multiple case study of two different QI implementation processes in primary care in Norway [ 16 ].

Contextual setting

A large externally driven QI (leadership guide) implementation study was supplemented with a tracer project [ 17 ] involving an internally driven QI implementation to understand the differences and similarities of implementation processes in primary care. Primary care refers to nursing homes and home care services in this study. In Norway, primary care is the responsibility of municipalities. To frame this responsibility there is a regulation stating the requirement of continuously improving quality and patient safety in primary healthcare [ 18 , 19 ]. This regulation inserts a need for leaders to plan, implement, and evaluate output from QI implementation processes. Leaders are therefore key actors for quality and safety improvements. As such, this study used leaders as informants for developing understanding of QI implementations in a Norwegian primary care setting. Based on the consensus of the importance of context for implementation processes [ 8 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ] this project provides a way of understanding and comparing healthcare implementation processes through two different approaches. However, both implementation processes share similarities, as both are seeking to implement a QI programme, both are within primary care, informants in both cases are leaders, and both are within the Norwegian primary care context. The split of the cases into an externally driven approach and an internally driven approach are not totally binary but represents the main tendency of their approach. However, the external case had to arrange for the homework internally, and the internal case engaged in an externally facilitated day of formal training provided by someone outside their organisation.

Internal case

Implementation for the internal case took place as an internally driven process in home care. The chosen QI programme was a competence improvement program focusing on observational competence, and included formal teaching of new knowledge, skills training, simulation training of new procedures and measurements, and new practical equipment. Formal teaching involved a day of teaching organized by the county’s Centre for Development of Institutional and Home Care Services (USHT), while the remining was up to the organization to facilitate and organize for (training, simulation, equipment, monitoring, and follow-up) [ 28 ]. USHT set the researchers in contact with two different home care districts who had chosen to initiate this specific QI program.

Data collection

The data collection informing this study was based on individual interviews after the implementation of the competence improvement program, to explore how the implementation process was experienced and evaluated. Only interviews of leaders and professional development nurses (nurses responsible for the professional development within the organization and as such hold an informal leader role) ( n  = 8) were included in the dataset, to ensure credibility in the cross-case comparison, see Table  1 . Researcher TS performed all interviews, following a semi- structured interview guide (supplementary file). All interviews were recorded and transcribed verbatim.

External case

The external case concerned the implementation of a QI programme (SAFE-LEAD) developed by the researcher group aimed at leaders in primary care (nursing homes and home care services) [ 16 , 29 ]. The QI programme consisted of a leadership guide to support leaders in their QI work. The leadership guide was based on the QUASER hospital guide [ 6 ], which was translated and adapted to the Norwegian primary care context [ 29 ]. The QI programme included three steps with associated workshops, facilitated by the research group, and with following “homework” for the participants to perform between each workshop. The first workshop aimed at identifying challenges within the organization. “Homework” involved an evaluating and scoring system to formalise challenges of the organization to work on. The second workshop included the development of different objectives for improvement on identified challenges. “Homework” at the second step concerned the development of formalized objectives. At the third workshop, the focus was on the development of action plans in each organization. “Homework” after the third workshop was for leaders to translate action plans into practise. The “homework” sessions provided the participants time to work with the material introduced in the workshop. As such, “homework” was a way to provide ownership to the QI programme by translating the content of the leadership guide to their context specific understanding, setting strategies and objectives for their unit.

The researcher group facilitated the implementation process through workshops focusing on self-diagnosis of the organisation, goal settings, and action plans. The workshops included presentations and knowledge sharing of upcoming tasks, monitoring of progress, discussions, and homework review. The participants were leaders from eight units (4 nursing homes and 4 home care services) in five municipalities, within three Norwegian counties. The researcher group (ER, TJ, IA, BU, LHT, EHR, TS, LS and SW) responsible for the workshops were also performing the interviews. The empirical data used for this study totalled 13 interviews (10 focus group interviews and 3 individual interviews) ( n  = 26) with leaders in all 8 units during a one-year period (April 2018 – March 2019), see Table  1 . A semi-structured interview guide was used for the interviews and all interviews were recorded and transcribed verbatim (supplementary file).

Data analysis

Due to the explorative nature of the research questions, an inductive approach was found most appropriate to explore emerging themes from the empirical data, as existing frameworks describing differences and similarities between internally driven and externally driven implementation processes in older adult care were not identified. This gap in literature informed an inductive approach. The analytical process followed a grounded theory methodology [ 30 , 31 ] where empirical data from the two cases were first inductively analysed individually, followed by a second step of cross-comparison. Grounded theory is described as a valuable approach for theory development and as such a way to address the theoretical gap described in the above [ 30 ]. The NVivo 1.7 software was used to support the analysis and for documentation of findings. Figure  1 illustrates the inductive data structure from the analysis, following the grounded theory framework by Gioia et al. [ 30 ]. The data structure includes a first inductive step of identifying 1st order codes emerging directly from the data. These 1st order codes were aggregated into 2nd order themes, and later on into more abstract 3rd order dimensions [ 30 ]. As such, 1st order codes display manifest meanings from the dataset. The researcher (HBL) identifying the 1st order codes had not been part of the data collection, workshops, or the QI programme development and was therefore able to keep an inductive approach throughout the analysis. 2nd order themes and 3rd order dimensions were agreed upon by all authors. All authors have expert competence in qualitative inductive research. A summative analysis of the results from the matrix were used to identify enablers and barriers occurring in the dataset.

figure 1

Data structure model based on Gioia et al. [ 30 ]

The analysis revealed 1845 references which were coded over 284 different inductive 1st order codes emerging from the internal dataset and 3286 references coded at 190 different 1st order codes from the external dataset. A matrix where crosstabulations between successful and unsuccessful outcomes (1st order codes) in each case and the total number of codes provided the association of enablers and barriers displayed in Fig.  1 .

Successful outcomes referred to factors, resources, activities, and practices reported to have a positive impact on the implementation process. Unsuccessful outcomes referred to the opposite, where factors, resources, activities, and practices, were reported to have a negative impact on the implementation process. Successful outcomes for the internal case disclosed 122 occurrences and 115 occurrences for the external case. Unsuccessful outcomes for the internal case totalled 110 occurrences and 94 occurrences for the external case.

As displayed in Fig.  1 , some 1st order codes were coincident for both the internal and external case, while others were of a more situation specific nature. As 1st order codes emerged inductively and were analysed separately within the two different cases and furthermore at different points in time, 1st order codes might therefore be named differently, like e.g., dedication and ownership (internal case) and engagement (external case) but with similar underlying meaning. The identified barriers and enablers of the two cases were in a second step put in a Venn diagram to explore and illustrate cross-case similarities and differences (see Figs.  2 and 3 ).

figure 2

Enabler’s relatedness to externally and internally driven implementation processes. Learning includes both the continuous learning and knowledge transfer enablers

figure 3

Barrier’s relatedness to externally and internally driven implementation processes

Table  2 illustrates the findings, in terms of different codes and the number of occurrences, according to RQ 1. The data structure model and the following result section describe successful and unsuccessful outcomes, focusing on most present occurrences within the dataset for each case to align with the first research question of identifying enablers and barriers of the implementation (Fig.  1 ; Table  2 ).

In the following different enablers, illustrated in Table  2 ; Fig.  1 , will be described in more detail.

Continuous learning, simulation training and knowledge sharing

The importance of continuous learning was emphasized in the internally driven implementation process. A continuous focus of learning was needed to ensure ownership of the QI programme, and for making new practices and knowledge an integrated part of the culture and everyday work. Leaders, through their decision to engage and to coordinate training, were found important for facilitating this continuity of focus. As such, having weekly simulation training was perceived more favourable than having yearly seminars for the staff. Continuous learning was also of importance for the external case, yet in a lesser degree due to having visits from researchers that provided reflexive spaces and learning at predefined points in time.

“I’m so happy we engaged into this project, which gave us the results I expected. Yet, there is something that comes with this (the QI programme). We can’t stop with simulation training, as this needs to be of focus always.” (Internal implementation process).

As the quote above states, simulation training was not a one-off activity, but needed to be put in a system of repeated and continuous exposure to be beneficial. However, when simulation training firstly was introduced to the staff, it was met with high levels of resistance. Simulation training made the staff feeling exposed and evaluated, which again made them feel insecure. As time went by and the staff got more familiar with simulation training, they changed their opinion of simulation training as they discovered its value, relevance, and the inherent flexible ability to illustrate everyday issues.

Simulation training was found a pillar for the internal case but was not a part of the external implementation process, which explains this difference of occurrences across cases. However, aspects of knowledge and learning were similarly found to be of highly importance for the externally driven implementation process. Knowledge sharing for the externally driven implementation process was mainly organized in inter-organizational workshops facilitated by the researchers. As such, these workshops acted as means to develop relations between leaders across different parts of the organizations and furthermore a way to learn from each other’s successes and mistakes when organizing for QI.

“We know that A (home care department), which previously were a part of B (another home care department), has very good experience in initiating socio-professional evenings, which were very well attended. But, we (B) have struggled to make this happen. We are now planning to develop a culture for this (socio-professional evenings). We will therefore try to learn from their experiences. This is a way of using experiences from other organizations to make changes. Learning from the positive culture of other organizations” (External case).

Other dimensions of knowledge sharing highlighted in the external case were having access to meeting arenas, to facilitate knowledge sharing across organizations, providing a direction of focus for the implementation. Furthermore, receiving feedback from different actors, both vertical (different levels) and horizontal (different departments) provided a more holistic understanding and knowledge of the contextual situation for the leaders.

Perceived relevance

Willingness to put in necessary time and effort into the implementation process, relied on a perception of the outcomes to be relevant for their organization. The perceived relevance of the QI programme was found key for engagement and dedication in both cases. For the externally driven implementation it was not enough to just have motivated external researchers on visits to facilitate workshops, the motivation had to be present within the organization. Relevance in terms of quality further involved the development of a shared understanding of quality among healthcare professionals and their leaders. Hence, reflections over the meaning of quality were perceived as a valuable exercise.

“Often, they (front-line staff) say: “We need more people at work”. Based on front-line staff, this is kind of the solution for everything. However, this is not the case. I mean, we can provide quality in a good way, even though our time is limited, by providing good quality in what we do. And by having good procedures”. (External case).

Perceived relevance was also important for the internal implementation, even though this was raised in a lesser degree as the internal QI programme itself was specifically chosen by the leader for its relevance to their service.

Dedication, ownership, and engagement

Dedication, ownership, and engagement was found enabling in both cases. Engagement was crucial for the ownership of new procedures and perspectives. For the external case, the informants highlighted a need for leaders to develop a firm ownership of the implementation, as explained in the following quote:

“We had kind of decided this. We are a group that like to carry out things in clinical practice, not just making plans, but to actually realize them. I believe this is something we all are interested in. Therefore, it is important to make a plan, because it (the leader guide) needs to be anchored in management, and then we all have to work further to spread it (in practise). This is not something that can be done in 5 minutes, we must work with it (the leader guide) over time. And because this is something we have all agreed on, we will manage”. (External case).

For the internal implementation process, ownership was associated with the adoption of new procedures. Learning new procedures and measures, made especially individuals with a lower level of formal education feel safer when making decisions, resulting in a reduced need for contacting nurses, physicians, and emergency departments to get advice and supervision. Furthermore, in situations where there existed a need for contacting other healthcare professions (like physicians and emergency departments), the new knowledge allowed healthcare professionals to concretize their information, making it easier for physicians and emergency departments to target their advice. This can be exemplified by the following quote.

“They (health workers with lower formal education or no education) have evolved so much and have become so much more confident. They are the ones who have developed the most from this (the QI programme). And they have enjoyed it. And now they come back (to the home care central) and proudly stats: “I participated to a hospitalization”. This is so nice for us all to observe. (Internal case).

Technology and tools

Having access to appropriate tools, technology, and simulation equipment, were found enabling for implementation in both cases. It is important to notice, at this point, that technology and tools also were reported as a barrier. Meaning that technology and tools need to be accessible, easy to use, providing an overview, and easing information transfer to act as an enabler, if not, they may end up as a barrier. As such, the digital version of the leadership guide in the external case acted as an enabler providing accessibility to the learning resources, but also as a barrier if challenges in its use emerged.

One of the most important resources provided within the internal QI programme, was found to be the simulation equipment. Even though staff were reluctant to engage in simulations at first, they started to increasingly value this form of training as they got more familiar with simulation training. Findings showed that by only providing staff new tools (e.g., oximeters and blood pressure monitors) to not be sufficient to improve practises unless staff got properly trained in using them. Facilitating simulation training to ensure the correct use of new equipment was therefore enabling for internalization of new practices, as exemplified in the following quote.

“We found it necessary to include certain procedures in the simulation sessions. We then discovered that some people measured blood pressure incorrectly, and that some measured temperature incorrectly. Respiration was not always measured correctly, and not always the pulse. Therefore, even though we have been providing training, we still need to repeat the training over and over”. (Internal case).

Systematic approach and coordination

A systematic approach provided continuity of the implementation process and furthermore acted as a support structure for both cases. For the internal case a systematic approach was needed to coordinate training of all staff in new procedures and measures.

“Having a systematic plan for simulation training and lists of who is to be participating or not, has worked really well. And also, giving staff the responsibility for their own equipment, like the equipment bags, has also worked well”. (Internal case).

While the internal case had to coordinate the full implementation process themselves, participants in the external case were given “homework” by the external facilitators to perform between each pre-set meeting. Systematization in terms of coordination of the homework was found highly enabling for the external case. Systematization and coordination of the implementation approach are therefore highly related aspects in this study. To provide ownership for participants in the external case, self-organization in the coordination of homework, like in defining of goals and the initiation of action plans, was found enabling as a way to align the implementation process to their specific context.

In the following different barriers, illustrated in Table  2 ; Fig.  1 , are described in more detail.

Workload, turnover, coping with given responsibilities, staff variety and challenges in coordination

There was consensus across cases on the influence of workload as a barrier for implementation. The daily and already busy workload for health care professionals meant that the implementation of new QI programmes put on extra strains and responsibilities for the participants and the organization. Coping with these extra responsibilities was found challenging for the participants even if they perceived the implementation to be highly valuable for quality.

“They sent us to the course, which was nice. But suddenly I was responsible for all the simulation training, without being familiar with it. And I didn’t even want it….How was I to cope with this in daily practice, when I didn’t even have knowledge of it (simulation training)” (Internal implementation).

The same holds for the externally driven implementation process where they were given “homework” to perform between workshops. This was perceived as extra work to be performed on top of their already busy schedule.

“I remember well when it (the leader guide) was provided to us. And then I thought – how exiting. Really exciting. But then it (the leader guide) kind of got lost in everything else. The institutional leader quit her job at the same time, which also impacted us…However, to be able to have more focus on these things (quality improvement) would have been amazing” (External implementation).

The quote above further points to another emerging code, turnover, which was perceived as an important barrier. For the internal case, the training of new staff in the QI programme practices was experienced as time consuming and the overall implementation process therefore got negatively affected by turnover, as described in the quote below. For the external case, turnover of key personnel during the implementation process was found to be a barrier as it was difficult to find replacements to take over as implementation agents, as described in the quote above. This reflects the importance of continued engagement of the implementation process to facilitate for the development of ownership and internalisation.

“Barriers are typically turnover. And when training people in home care practices, there is a lot to teach them. It takes a really long time before you as a nurse or skilled health worker get hold of all the little things that we do here. So, this is difficult” (Internal case).

Healthcare workers in primary care are a diverse group, with variations in formal education, experiences, and contextual knowledge. This means that the implementation process needed to be aligned to the receiver, something leaders at times found challenging due to the staff variety (competence, perspectives, experience, education), reflected in the quote below.

“There are so many who should be seen and heard and all that. But I think this (QI programme) is important, especially for skilled health workers, it is important that they are lifted, and receive feedback on what they do well. Because there is a bit of rivalry between the professional nurses and the skilled health workers. Some professional nurses react when I praise them, because they feel this is only what should be expected. While others…It is difficult to applaud too much because you never know how it is received” (Internal case).

Technology and Tools

Technology and tools were found to possess a dual role as both enabler and barrier. When technology and tools were acting as a barrier it was caused by limited accessibility, compatibility, and output. The leadership guide in the externally driven implementation process was provided to the participants in both a paper version and as a digital website version. Most participants preferred the digital version due to accessibility. However, some elements of the digital version were perceived challenging by the participants, like the storing of the results, and as such a barrier for progress with the “homework”.

Lack of appropriate competence and knowledge sharing

The large variety in terms of formal education and contextual experiences meant that some employees felt that they were missing the appropriate competence to perform some specific practices. Like in the internal case where some of the simulation facilitators were unfamiliar with what they were expected to learn to their colleagues. As such, some facilitators needed more knowledge and training themselves before having to initiate training for others.

Some of the professional content has been very difficult, since I’ve not previously worked with this stuff. Among this, the use of the elevator. We have worked with a scenario of falls. I know falls very well, but I cannot use the elevator. And suddenly I’m supposed to teach the others in how to use the elevator”. (Internal case)

Knowledge sharing was also found to possess a dual role as both enabler and barrier, which reflects the importance of knowledge sharing for implementation. For the external case, lack of knowledge sharing was related to a lack of suitable arenas for knowledge sharing. Formalized meeting arenas were limited, which often resulted in a need to share knowledge, and to receive feedback, of more or less everything within the same meeting. As such, raised topics were only dealt with superficially.

“We have discussed this a bit between us. We want to have a forum. Yes, a forum for adverse events where we can air adverse events on a general basis” (External case ).

Standardizations not aligned with work and extensive documentation

Standardizations were perceived as counterproductive for quality improvement if the standardizations and routines were not properly aligned with daily work. The informants also reported that the number of standardizations, guidelines, and routines to be implemented made them less compliant to keep up with them all.

“I’m much less compliant to standardizations from the government, and the municipality, of what is of importance at the moment. This has nothing to do with quality, it is about logistics, so let us instead focus on quality.” (External case).

The same also holds for documentation. If standardizations, guidelines, and procedures required extensive documentation, then health care professionals were more reluctant to engage. A consistent problem in home care services was the use of computers. Healthcare professionals only had access to I Pads when visiting patients, meaning that they had to wait until they were back at the home care central to perform reporting and documentation. Another problem was the limited number of computers available at the home care central, meaning that they sometimes had to que up for reporting and documenting. The number of different software to enter for reporting and documenting, with corresponding passwords, was also perceived a barrier for compliance.

“The staff do not sit in front of a computer. It is very difficult to get them to use the computer, using their e-mail, and all this. It is a big challenge because they are not using the computer unless when they are writing up the report” (External case).

Cross-case analysis

In accordance with RQ2 the results described above were structured in terms of coinciding and context specific factors, for which the visual result provides us some new understanding, see Figs. 2 and 3 . It is important to notice that all factors influenced the implementation process, and each other, in rich and complex ways. For enablers, most factors were found coinciding across the cases. This means that the identified coinciding factors, were important for succeeding with healthcare implementation and should be of focus for leaders, facilitators, and implementation agents.

However, when identified barriers were structured across cases in a similar diagram, an opposite pattern surfaced. Workload was the only coincident factor across the cases, and the other factors were found more context specific. This pattern provides the understanding that workload is a common and important barrier, that needs to be of focus in all implementation processes. Yet, to circumvent barriers, contextual knowledge of the implementation setting, and furthermore characteristics of the QI programme, are necessary to understand contextual barriers for implementation. By having contextual knowledge, leaders, facilitators, and implementation agents can work to align the implementation process to the situational context, like available resources, level of competence, turnover, staff variety, technology, and the appropriate level of documentation and standardization.

We performed a qualitative study in nursing homes and home care services and identified enablers and barriers for externally and internally driven QI implementation processes. We found that technology and tools, ownership, and learning were coinciding enablers, while workload was a common barrier across the implementations processes. We also identified several barriers and enablers that differed between the externally and internally driven implementation processes. In the following we discuss these and relate them to previous research and especially the conceptual and layered framework of Lau et al. [ 11 ] focusing on intervention characteristics, external, organisational, and professional factors to understand success and failure in QI implementation processes. The frameworks by Lau et al. [ 32 ] and Damschroder et al. [ 33 ] have a different focus of study and the relatedness to these frameworks were therefore only identified after the indictive data analysis was completed.

Conceptual framework for enablers and barriers of healthcare implementations

The findings illustrate diverse enablers and barriers for externally driven and internally driven implementations. Exploring the results from this study in relation to the framework by Lau et al. [ 11 ], the following categorization depicted in Fig.  4 can be developed. Each level (external, organisational, professional, intervention) influences the others, meaning that the different levels are interdependent elements of implementation processes and need to be understood as a contextualized entirety. Each level will be described in more detail in the following.

figure 4

Enablers and barriers from both cases in relation to the intervention, and professional, organizational, and external factors. Green text refers to enablers and red text refers to barriers.

Adapted from Lau et al. (2015)

Factors concerning the intervention/QI programme

Factors associated with the nature of the intervention/ QI programme itself refer to the identified enabling factor of perceived relevance. Relevance aligns with what Lau et al. [ 11 ] identified in their review on the importance of relevance, clarity, and practicality, all pointing to a need for the QI programme to provide benefits for practice, economy, patient safety, and efficiency. Efforts to make the QI programme perceived as relevant, relied on a fit between the situational context and the QI programme, thereby highlighting a need for user involvement during QI programme development. This finding is echoed in Cresswell et al. [ 7 ] where an alignment to the organizational context is not perceived as satisfactory unless the QI programme is aligned with clinical needs as well. Lau et al. [ 11 ] furthermore points to a need for leaders and implementation agents to clearly state the relevance of the QI programme in early phases of the implementation process, to provide willingness of staff to engage. This was also present in the external case where the researchers had to highlight the relevance of the QI programme for the participants to raise engagement and ownership [ 34 , 35 ]. Damschroder et al. [ 14 ] and Ree et al. [ 35 ] reports adaptability of the QI programme as a key factor for ensuring fit to the situational context. This is also reflected in our study where outcomes of the QI programme, in terms of quality, needed to be adapted to their specific context to be classified as relevant. Granja et al. [ 3 ] in a literature review found perceived quality for healthcare to be the most mentioned category for success, relating quality to contributions for professional performance standards and clinical practice.

Technologies (digital version of the leadership guide in the external case) and tools (clinical equipment in the internal case) were also part of the QI programme itself and could introduce both positive (accessibility and improved practices) and negative impact (software challenges and lack of appropriate competence) to the implementation process, as described in the result section.

Professional factors

Moving to the next circle of professional factors, which refers to influence, competence, and self-efficacy [ 11 ]. Professional factors encompass several findings within this study; enabling factors include ownership and engagement, simulation training and knowledge sharing, and barriers refer to a lack of appropriate competence and knowledge sharing, coping with given responsibilities, and staff variety. The marked role of knowledge sharing is evident through its position, as both an enabler and, if missing, a barrier. Knowledge sharing is essential for the dissemination of information, knowledge, and experience in both formal and informal channels throughout the implementation process. Furthermore, a lack of appropriate knowledge was also found hindering. This is reflected in the internal case where the staff variety made knowledge transfer more difficult, as they held different levels of competence and experience and thus required different resources for learning and training. This corresponds with Lau et al. [ 11 ] stating that adequate competence act as a facilitator for implementation success. Furthermore, Cresswell et al. [ 7 ] describe actors in possession of appropriate knowledge to be more positive towards new technology and services, than actors without appropriate training. The authors also describe a need for tailoring the training and to make it close to practise, which provides understanding to the importance of simulation training for the internal case [ 7 ].

Ownership was found of influential in both the internal and external implementation process. This corresponds with Lau et al. [ 11 ] who emphasize motivation and attitudes as enabling for change. For the external case, having the opportunity to adapt the implementation process to their setting was key for developing motivation. This issue of self-organization was not raised in the internal case as they by definition were responsible for the organization of the implementation. Greenhalgh et al. [ 10 ] describe ownership and adoption as a process, needing time to develop. Facilitators for this process were described to be appropriate knowledge of the output of the innovation/ QI programme (perceived relevance and appropriate competence), continuous access to information (continuous learning), ability for contextual adaptation, and to receive adequate feedback (knowledge sharing). These findings from Greenhalgh et al. [ 10 ] illustrate interdependencies of their findings and furthermore the findings of our study, pointing to the need for keeping a holistic perspective of barriers and enablers.

Organizational factors

Continuity in learning enabled implementation, as in the internal case where continuous learning ensured ownership by repeated focus over time until new knowledge and procedures were internalized in form of routines and thought worlds. Other aspects of continuity, like in the external case where leadership turnover resulted in a disruption of the implementation process, also acted as a barrier for the implementation process. This echoes Damschroder et al. [ 14 ] who described continuity and stability of staff as facilitative for implementation success. Leadership is also highlighted in Lau et al. [ 11 ] study, as means to identify champions, drive change, and for the communicating of objectives for the implementation process. The authors further report that early engagement by leaders as valuable for the adoption of the QI programme. This understanding is echoed in this study in relation to leaders’ dedication and engagement to the implementation process.

Another factor that acted as both an enabler and a barrier was coordination. Well organized and structured plans for the implementation process were found facilitative. Allowing participants autonomy and room for self-organization were emphasized as a way of adapting the implementation process to front-line work in our study, similarly to Cresswell et al. [ 7 ]. This refers to what is described by Greenhalgh et al. [ 10 ] as fuzzy boundaries, where innovations in services organizations, like healthcare, includes a hard core of fundamental elements that need to be unaltered to maintain the purpose of the innovation, and a soft periphery providing adaptation to the context [ 8 , 12 , 27 ]. This is further echoed in this study where QI programmes involved a fundamental hard core (different measurements and procedures to perform/leadership guide with assignments) and a soft periphery (how, when, where, and with whom, learning and homework are performed).

However, coordination also acted as a barrier, put forward due to the complexity in care and the huge variety in training and education among staff. This understanding is also mirrored in the description by Lau et al. [ 11 ] on how skill mix issues may impede coordination of responsibilities and roles. Related to coordination, was also the enabler of having a systematic approach. Systematization of the implementation process was perceived as a support structure, as it eased the overview of the training process and furthermore provided an ability to monitor progress. This means that the flexibility to adapt and translate the QI programme, described facilitative in the above, needs to be accompanied with some support structures, like infrastructure and planning to ease the implementation process [ 7 ].

Workload was heavily reported as a barrier in this research, where limited time and effort to engage into the implementation resulted in a lack of ownership and engagement. Workload as a barrier for implementation is previously described in various research. Granja et al. [ 3 ] found workload to be overrepresented as a barrier within their systematic review, and Carlfjord et al. [ 2 ] describe workload to reduce the ability to engage into the implementation process. The implementation of new QI programmes therefore needs to align adoption efforts to workload, or else the implementation process may end up as a burden for healthcare workers already in a pressed and hectic work situation [ 36 ]. Bates and Singh [ 1 ] describe workarounds, for time saving purposes, as outcomes if the QI programme and implementation process are not aligned with workload.

External factors

Nursing homes and home care services are the responsibilities of Norwegian municipalities. However, even if this structure allows for local decisions and prioritizations concerning quality improvement, the municipalities still need to align to national regulations, guidelines, and external factors. External factors found to influence the implementation were technology and tools, standardizations not aligned with work, and extensive documentation. Technology and tools therefore acted as both an enabler and a barrier for the implementation cases in this study. This is in line with Greenhalgh et al. [ 10 ] arguing that when tools are perceived as easy to use, the potential for successful implementation increases. Furthermore, appropriate, and useful knowledge for how to use technology and tools need to be present, findings which are echoed in Cresswell et al. [ 7 ].

When not perceived as accessible and useful for daily practise, technology and tools introduced a lack of motivation and workflow, thereby reducing the perceived incentives of engagement. Disruption of workflow was a significant finding in Granja et al. [ 3 ] due to a gap between the technology and the context. As a barrier for implementation, technology and tools are related to extensive documentation, referring to a lack of compliance to demands of documentation due to insufficient compatibility in technological systems, increased workload, limited resources, and poor functionality. This is furthermore mirrored in Lau et al. [ 11 ], stating that infrastructure, technology advances, and a lack of clear incentives are important external factors of implementation. Standardization and documentation, not aligned with work, are factors mostly initiated and decided upon externally, like from the specific QI programme itself, and from regulations and guidelines from the national level. However, even if decided outside of the organization, it is to be performed by individuals and teams within the organization. This means that some room for adaptability to context need to be present, if not they may act as a bottleneck for efficiency.

The Norwegian government has initiated a regulation stating the need for healthcare leaders in nursing homes and homecare services to ensure continuous quality improvement within their respective organizations. As such, there are formalised requirements for primary care leaders to take on different quality improvement interventions. However, which type of interventions to implement will often be up to the primary care leaders to decide upon, except for national programs where all units are to engage. The guidelines for which type of approach to use for the implementation process are also formed with flexibility for leaders to decide, based on what is most appropriate for their organization. Awareness of enablers and barriers for different approaches can potentially be of support for leaders in their quality improvement work. Furthermore, our findings display the benefit of providing flexibility for local adjustment of the intervention and implementation process which can inform policy makers to provide a room for adjustments in national programs.

Strengths and limitations

This study has some limitations. First, as in all qualitative research the findings from this study are not transferable. Second, it may be considered a limitation that the internal and the external case implemented different QI programmes. However, a principle for the overall study was to allow the internal case to choose their own QI programme and furthermore to implement the QI programme on their own without any impact from the researchers. Third, it is relevant to mention that the internal case only included home care services, while the external case included both nursing homes and home care services. Forth, only interviews of leaders and professional nurses were included as empirical data for this study to explore the perspective of the implementation agents and to make the empirical foundation more similar across the cases. Other findings may therefore have emerged if the dataset also incorporated employee interviews and observation notes. New studies should therefore seek to perform similar studies informed by both leaders and employees. Fifth, the data collection in the external case included both individual and focus group interviews, while the internal case included only individual interviews. For the external case, the two individual interviews were chosen due to the geographical distance of this nursing home. Furthermore, the two leaders were not located in the same unit so individual interviews were found more convenient. The choice of using individual or focus group interviews have both pros and cons, where focus group interviews allow for more discussion and as such a way to generate more ideas, while individual interviews provide psychological safety as what is reported is only between the researcher and the informant [ 37 , 38 ]. An additional factor to balance was the use of the leader’s time to conduct the interview. The interviews were therefore performed at the leader’s location which made it necessary to allow for both focus group interviews and individual interviews [ 39 ].

The major strength for this study is the comprehensive dataset, including several municipalities and institutions. The data was collected over time, providing credibility to the study. Additionally, the focus of leaders in both cases provides the ability for cross-comparison of the different implementation processes.

The aim for this study was to explore enablers and barriers of two different implementation processes of QI programmes in nursing homes and home care services, where the implementation in one case entailed an externally driven process, while the second case entailed an internally driven implementation process. As such this study theoretically contributes to calls for research on different contextual settings of healthcare implementations and further to calls for implementation studies to take place in primary care settings.

This study shows that workload acted as the main barrier for implementation in both externally and internally driven implementation processes. Based on the current state of primary care with burnout, stress, and lack of qualified healthcare professionals causing a mismatch of demands and capacity in healthcare services, implementation of QI programmes needs to be aligned with their everyday work to not be perceived an extra burden [ 36 ].

Other barriers and enablers in need of extra focus in implementation processes are factors that acted as both barriers and enablers, like technology and tools, continuity in learning and staff (turnover), and coordination. Tightly monitoring these factors throughout the implementation process may provide a positive impact.

Dedication, engagement, and ownership are other factors which need to be emphasized. These enablers were raised in both cases. However, the influence of other enablers and barriers to facilitate or hamper the development of dedication, engagement and ownership leaves these factors of importance for implementation processes.

Future studies should seek to explore similar phenomena in different countries and at different parts of healthcare services, to develop an understanding of the findings in different contexts. Furthermore, future studies should also explore implementation of different QI programmes and compare different types of implementation processes in terms of timespan, level of change introduced by the QI programme, and alternative ways of facilitating the implementation process, like having mixed externally and internally processes, as well as front-line initiated and government-initiated QI programmes.

Data availability

The datasets used and analysed during this study are available from the corresponding author on reasonable request.

Abbreviations

  • Quality improvement

Improving Quality and Safety in Primary Care – Implementing a Leadership Intervention in Nursing Homes and Homecare

Centre for Resilience in Healthcare, Faculty of Health Sciences

Centre for Development of Institutional and Home Care Services

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Acknowledgements

The authors would like to thank all participants in the involved nursing homes and home care services for participating in the study.

Open access funding provided by University of Stavanger & Stavanger University Hospital. The work is part of the Improving Quality and Safety in Primary Care – Implementing a Leadership Intervention in Nursing Homes and Homecare’ (SAFE-LEAD) project, which has received funding from the Research Council of Norway’s program HELSEVEL (grant agreement no. 256681/H10), and the University of Stavanger. The funding body played no role in the design of the study, data collection, analysis, or in writing the paper.

Open access funding provided by University of Stavanger & Stavanger University Hospital

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Contributions

HBL and SW advanced the initial idea for the article. TS introduced and contributed to the discussion of data/results according to the framework of Lau et al. (2015). ER, TS, TJ, IA, BU, LHT, EHR, LS and SW performed the data collection. HBL led the analysis, and all authors contributed to the steps of the analysis and agreed on the final results. HBL drafted the manuscript with significant contributions from ER, TS, TJ, IA, BU, LHT, EHR, LS, DWB and SW. All authors have read and approved the final manuscript.

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The Norwegian Regional Committees for Research Ethics considered this study not to be governed by the Health Research Act. The Norwegian Agency for Shared Services in Education and Research approved ethical data management for the study in two phases (Phase 1: NSD, ID 52324; Phase 2: NSD, ID 54855). The study followed the Helsinki Declaration. All participants gave individual informed written consent to take part in the study and were informed that they at any point were free to redraw their participation.

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Lyng, H.B., Ree, E., Strømme, T. et al. Barriers and enablers for externally and internally driven implementation processes in healthcare: a qualitative cross-case study. BMC Health Serv Res 24 , 528 (2024). https://doi.org/10.1186/s12913-024-10985-2

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  • Implementation
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longitudinal case study qualitative research

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