Implementation of a Complex Health Services Intervention in Long-term Care Homes: A Process Evaluation Using Focus Groups

With increasing numbers of the elderly living in nursing homes in Germany, the need for on-site primary care increases. A lack of primary care in nursing homes can lead to unnecessary hospitalization, higher mortality, and morbidity in the elderly. Therefore, project CoCare (“coordinated medical care”) implements a complex health intervention in nursing homes, using among others regular medical rounds, a shared patient medical record and medication checks, aiming to improve the coordination of medical care. This study reports the results of a process evaluation assessing the perceived acceptance and barriers of the project by stakeholders.


Abstract Background
With increasing numbers of the elderly living in nursing homes in Germany, the need for on-site primary care increases. A lack of primary care in nursing homes can lead to unnecessary hospitalization, higher mortality, and morbidity in the elderly. Therefore, project CoCare ("coordinated medical care") implements a complex health intervention in nursing homes, using among others regular medical rounds, a shared patient medical record and medication checks, aiming to improve the coordination of medical care. This study reports the results of a process evaluation assessing the perceived acceptance and barriers of the project by stakeholders.

Methods
Focus group interviews were held between the fall of 2018 and the fall of 2019 with nursing staff, general practitioners and medical assistants working in or consulting a participating nursing home. A halfstructured modular guideline was used to ask participants about their opinion on different aspects of CoCare. Focus groups were analyzed using qualitative content analysis.

Results
In total, N=11 focus group interviews with N= 74 participants were conducted. Ten main themes with seven subthemes were identi ed, encompassing all aspects of CoCare. The overall acceptance of the project was good. Participants elected to talk most often about the project modules "communication and collaboration" and "medical rounds", with participants concluding CoCare had prevented unnecessary hospitalizations. Main barriers were understa ng and complexity of the program.

Conclusion
Implementation of CoCare in nursing homes is complex and holds some barriers. However, the overall acceptance was good and rst positive results were reported by participants. Furthermore, the project provides a good structure to overcome potential barriers.
Trial Registration: German Clinical Trial Register (DRKS00012703) Background Demographic transition is in full swing in Germany, with every fth person being over 66 years old (1).
About two million people in Germany are in need of long-term care (2) and care provided in nursing homes (NHs) is seen as appropriate (3). Thus, in 2018, approximately 700.000 people were already living in NHs in Germany (2). Overall, higher age was shown to be associated with higher health care utilization compared to the general population (4,5). Yet, the level of care needed was negatively associated with the probability of utilizing medical specialists, showing inequality in health care system (6). Other reports show a lack of primary care in NHs (7), leading to unnecessary hospitalizations for the elderly (8)(9)(10). Unnecessary hospital admissions were not only shown to be costly (9,11), but also increased the risk of complications and mortality in NH residents (12,13). The insu cient availability of general practitioners (GPs) and acute care were determined to be the main reasons for unnecessary admissions to the hospital in several studies (9,14). However, the implementation of primary care in NHs is hindered by the lack of infrastructure or insu cient compensation of physicians. Project CoCare ("coordinated medical care") aims to bridge the gap by implementing a complex health care intervention to improve primary care in NHs (15). The study takes place in the federal state of Baden-Wuerttemberg, Germany, with 31 NHs implementing the new intervention, providing it to approximately 1,150 residents. Furthermore, 25 NHs providing survey data will be used as control group and additionally claims data of N=8,000 of NH residents in Baden-Wurttemberg will be randomly drawn for comparison. Among others, the intervention provides a shared patient medical record called CoCare Cockpit (CCC) and standard courses of treatment for NH staff and consulting GPs. Furthermore, it compensates weekly on-site medical rounds, regular medication checks, case conferences and extended availability of GPs. CoCare also aims at improving communication and collaboration between GPs and nurses by forming teams of physicians sharing care duties and by appointing a CoCare contact person in every NH. As results, an increase in quality of care, care e ciency as well as a reduction in costs are expected. See Figure 1 for an overview of all modules of the project. Further information on the project and its study design has been published elsewhere: Brühmann, Reese (15).
In accordance with the guidelines for complex services interventions by Moore, Audrey (16), a formative process evaluation is conducted for this project. Acquiring speci c information on the implementation process is crucial for decision makers before implementing the intervention on a larger scale. A process evaluation will therefore investigate how a complex health intervention is delivered and how the delity for the intervention is (17,18). This paper describes the results of the qualitative process evaluation for project CoCare that were obtained using focus group interviews investigating the acceptance of the intervention by stakeholders and the barriers for implementation.

Study Design
Participants were GPs, nursing staff and medical assistants working in or consulting a NH enrolled in CoCare. Focus groups were conducted between fall of 2018 and 2019. Participation was voluntary and no disadvantages arose from non-participation. Participants were supplied with information on the aim of the focus group interviews and written informed consent was obtained from all participants. As the project team used various methods for the process evaluation (15), some of the participants and researchers knew each other from previous contacts.
Focus groups were conducted using a half-structured modular guideline, assessing the opinion of participants towards the different aspects of the project (see Brühmann,Reese (15) for a description of the project). A modular guideline was chosen as CoCare comprises many modules and using a modular guideline, participants were able to pick which of the many aspects within the intervention were particularly important to discuss. The interview guideline was developed for this study by the authors based on the study design of CoCare (15) and the expertise of the scientists (see Additional File 1). The interview guideline was also previously published in Brühmann, Reese (15). Focus groups were conducted by CR and BB within the NHs. All focus groups were digitally recorded and transcribed verbatim by an external service provider. The transcripts were pseudonymized and given a consecutive ID-Number from 1 to 11. As the focus groups were held in German, participant´s quotes to illustrate the nding were translated into English by the authors of this manuscript.

Data analysis
Data analysis was based on the content analysis outlined by Mayring (20). For this purpose, an initial coding system was developed based on the modules from the modular guideline. VK and RvdW then analyzed the rst three interviews independently, using the initial coding system and taking notes as necessary. The results were discussed by VK and RvdW, adapting the coding system to the ndings. This process was repeated twice before generating the nal coding system (see Table 1). RvdW then coded the remaining focus groups using the nal coding system. The results were presented to and discussed at different stages of the data analysis with the project team to ensure intersubjective comprehensibility. Data management was done using MAXQDA 2020 (21).

Researcher characteristics
RvdW is a female researcher in the eld of health services research and rehabilitation research. She holds a degree in psychology and has experience with qualitative studies. VK is a female master student in psychology and works as a student assistant in the eld of health services research. Both, CR and BB are postdoctoral researchers in the eld of health services research and rehabilitation research. CR is a trained psychologist, and BB holds two degrees in health sciences. EF is a full time professor in health services research and rehabilitations research. His work focuses on methods in health services research.

Results
Participants N=11 focus groups with a total of N=74 participants were conducted. 78.8% of all participants were female. Most of the participants were nurses working within the participating NHs (n=48), followed by consulting GPs (n=20). A full overview of the distribution of participants can be seen in Table 2. As CoCare focuses on the medical team as a whole, differences between professions were not analyzed.

State of implementation
Because NHs entered the project at different times, the state of implementation differed across facilities. According to the participants, the biggest barrier for full implementation was the lack of available resources to devote to the intervention, like nursing staff's time. The issue of understa ng due to sickness or training was repeatedly mentioned.
However, even if single components had not yet been implemented in the NHs, participants emphasized that CoCare builds awareness for the health care of the elderly.
"It would be possible during normal business. But then? Someone gets sick, someone is absent, someone is in training. And suddenly no one is here or no one, who can….no one has time to do these additional tasks." (Focus group 1) "State of implementation" included the following subthemes: management of suprapubic catheters; barriers for implementation.

CoCare-Cockpit (CCC)
Participants had varying opinions on the CCC (electronic medical records). Overall, the idea of common electronic medical records between GPs and NH was rated positively. Improved preparation of medical rounds and automated treatment recommendations were named as positive aspects of CCC. However, many NHs struggled to make regular use of CCC, as regulatory standards require separate documentation of the provided care in addition to any records made in CCC. The resulting double documentation might lead to mistakes.
"And if you ask me, that would lead to mistakes, because every normal person, when they have written or typed the exact same thing for the third time, they would leave something out, no longer want to…(several other participants agree in the background)…every normal person would do that….( Focus group 11) The main theme "CoCare-Cockpit (CCC)" included the subthemes: use of CoCare-Cockpit; bene ts; barriers of use; double documentation.

Medical rounds
According to the participants, the newly implemented weekly medical rounds attended by GPs and nursing staff were one of the most important modules of CoCare. Even though some NHs had regular medical rounds before the project, but most participants reported positive effects. Holding rounds on the same day each week allowed for better preparation by both nursing staff and GPs. If GPs worked in a team at a NH, they would leave a message for the GP to lead the next visits. This way a continuous treatment of residents could be guaranteed. According to some participants, residents would feel much more comfortable since medical rounds were scheduled regularly. One participant said that the newly implemented GP´s visits were already preventing unnecessary hospitalizations.
"…due to these visits, I know all the patients, know their pathology […] and I would say, that we notice,… even skin changes or the patient has a little fever or something alike, so we can really prevent hospitalizations." (Focus group 7) Medication check In most NHs, medication checks are conducted during medical rounds. Participants stressed the importance of the medication checks, as some residents had been given a lot of medication. They valued that the project reminded them to conduct the medication checks regularly.
Medication checks were especially important after a hospital discharge, as hospital doctors would not pay attention to existing medication, changing the medication plan or adding new medication.
Additionally, participants wished that the CCC would give a warning if two or more medications had negative interaction effects.
But now, sitting down during the visits, looking at the medication plan together and talking about it with every professional.
[…] Most medications are from the hospital, stay in the plan or will be continued to be given.
[…] (Focus group 9) The project was seen as a team building intervention by many participants. Communication and collaboration are very important in NHs and CoCare might have led to more trust within the team. Due to the strict framework of the project more time for communication and consultations is left.
For nursing staff, the barriers to talk to GPs were lowered, making it easier to agree on a resident's treatment. Participants said teamwork was more professional in some NHs now and decisions were being made with the whole team involved. Also, participants regarded a consistent contact person within the NHs as positive.
GPs appreciated the newly built general pracitioners´ teams to consult a NH, as visits and treatment planning would be easier now.
Again, one participant mentioned that the improved communication within the team had already led to a prevention of unnecessary hospitalizations.
"When I come here, I have a number I can dial, I have someone who has time for me and is my contact person. And I need to say: There is some structure. When something is not clear, there is someone I can talk to." (Focus group 2) The theme "Communication and collaboration" includes the subtheme: general practitioner teams

Medical specialists
All participants were of the opinion that consultations of medical specialists, such as psychiatrists or urologists, are important. However, most participants said that it wasn't easy to nd specialists for regular consultations within the NH.
No other long-term care home believes us when I tell them that we have a neurologist who comes to see our residents regularly. That´s not something you see very often. (Focus group 1)

Extended availability
The extended availability of GPs during the evening hours was received very differently among participants. Whilst being accessible even in the evening was natural for some GPs, others refused to do it due to the high workload.
In some NHs with extended GP hours, GPs and nurses had the agreement to call the GP rst in case of need. Together with the nursing staff they would then decide what to do next. Again, one of the participants indicated that this new course of action had already helped prevent hospitalizations.
However, all participants agreed that to ensure extended accessibility, more GPs would be needed to distribute the workload better.
There is always someone to approach and we agreed that we would be called before an ambulance is requested. We then come around and have a look, if that is really necessary." (Focus group 1) Case conferences, quarterly and yearly meetings Case conferences as well as quarterly and yearly meetings had not yet been implemented in most NHs.
Most participants struggled to distinguish between the three kinds of meetings. One participant mentioned that they had been conducting quarterly talks within the framework of the regular medical rounds.
"So the medical rounds usually take a long time and the quarterly talk is supposed to be 90 minutes I think. I think we do that several times per quarter during the medical rounds, right?" (Focus group 4)

Standard courses of treatment
When asked about the standard courses of treatment, opinions differed between participants. For some participants, the standard courses of treatment were too detailed to learn and follow. Also, some participants did not know that the pathways were available as hard copy outside the CCC.
Other participants thought the standard courses of treatment were helpful, noticing that it made GPs mindful of previously overlooked issues. Especially the treatment pathway for the transition from curative to palliative care was mentioned to be particularly helpful. One participant reported that the standard courses of treatment were used as a template for further developments of other pathways, such as a procedure for urinary tract infections. Participants also appreciated the training given before the implementation of the standard courses of treatment.
"I thought the training was interesting, there were examples and categories: the agitated patient, the aggressive patient. That is extremely helpful, because it actually is a simple pattern, giving you a structure for problem solving." (Focus group 10) Overall assessment The overall assessment differed among participants. Some participants regarded the project as "genius", improving the care of residents in NHs. Due to the additional compensation; the GPs said they were in a good position to implement all aspects of CoCare. A special focus was put on the preventative aspect of CoCare, making it easier to treat residents' illnesses early. However, some participants stated that most aspects of CoCare already were the standard care in their respective NH. Some participants feared that if CoCare were implemented in standard care, it would be a bureaucratic hurdle.
"Of course, we want CoCare to be evaluated positively, because the system itself is genius and it would be a pity if it would not be part of the standard care in future." (Focus group 7)

Discussion
Results from the focus groups show that the project implementation is complex, and some modules were easier to implement or more important to some participants than to others. The overall acceptance of the project was good. However, some participants feared that the implementation in standard care because of the complexity and bureaucracy.
Pertinent German organizations recommend using tools like regularly scheduled medical rounds or extended availability to help improve interprofessional communication. Furthermore, nursing staff play a crucial role as they are the ones organizing interprofessional medical care in long-term care homes (22). CoCare combines all these tools, providing a solid framework to facilitate interprofessional communication. It is therefore not surprising that interprofessional communication was seen as one of the most important modules of the project, with CoCare being perceived as a team building intervention. Participants in our study valued the newly built teams of GPs and the contact persons within NHs. The implementation of a xed contact person was not seen as useful in a previous qualitative study assessing interprofessional collaboration in nursing homes in Germany (23). However, the authors noted that the lack of perceived usefulness was due to NHs already having a xed contact person for GPs before the intervention (23). Thus, it can be hypothesized that a xed contact person is perceived as useful when newly implemented in a NH.
Overall, interprofessional collaboration and communication was found to have an impact on health outcomes (24,25). For the elderly, interprofessional collaboration has positive effects on things like quality of life, mortality or length of stay in hospitals (26). Furthermore, there is some evidence that interprofessional collaboration is cost saving (27). Some participants in this study had already concluded that the improved collaboration and communication prevented unnecessary hospital admissions and therefore had an impact on health outcomes for residents.
Even though the overall acceptance of the project was found to be good, some barriers for implementation were reported by the participants. Participants mentioned that the project was complex and too detailed. For example, the purpose of case conferences, quarterly and yearly meetings could not be distinguished by some participants and therefore were not implemented in some NHs. In a scoping review, the intervention complexity was a common barrier for the implementation of integrated care (28), with rising complexity making it more di cult to implement the intervention (29).
Furthermore, the intervention was perceived as too bureaucratic by some participants who worried the implementation into standard care, especially as understa ng was seen as the biggest barrier for implementation. Previous reports found that staff would work overtime to compensate understa ng and bureaucracy (29). Even tough participants in this study did not mention overtime the issue of understa ng and overtime is well known in Germany with an average of 42 hours of overtime per nurse within six months (30).
All barriers reported by the participants are well known (28) and implementation of complex health intervention remains a challenge (31).Implementation of health services interventions, particularly complex ones, requires countless organizational and individual change processes (29). Completing these processes takes at least one year, most likely longer (32). With a project length of 42 months, CoCare provides a good time frame for full implementation and normalization. Furthermore, the project compensates higher workload for NHs and GPs and some barriers, such as the double documentation, will dissolve after implementation into regular care.

Strength And Limitations
With N=11 focus group interviews and a total of N=74 participants, this qualitative study compromises a relatively big sample size. Although generalizability cannot be reached with a qualitative study design, this study adheres to recommendations for the guidelines for the process evaluation of complex interventions (16).
Nonetheless, this design shows some limitations. First of all, results were not distinguished between professionals. However, doctors are known to evaluate collaboration and communication better than nursing staff within NHs (33)(34)(35). As the aim of this study was to analyze the overall acceptance and implementation, we decided not to distinguish between professions. Furthermore, as a modular interview guideline was used, not every focus group talked about every topic in detail. However, results show a good overview of acceptance and barriers perceived.

Conclusion
The results shown in this study are promising, with participants reporting a positive impact on health outcomes and a good acceptance of the intervention. Especially collaboration and communication seem to have improved. However, a nal conclusion can only be drawn after the summative evaluation has been completed. The quantitative evaluation will be primarily based on claims data and questionnaires and focus on the number

Competing interest
The authors declare that they have no competing interests

Consent for publication
All authors have approved the nal version of the manuscript.

Authors´ contributions
Data collection was performed by CR and BB. Data preparation and analysis were performed by RvdW and VK. EF did conceptualize the study and supervised all steps. The rst draft of the manuscript was written by RvdW and all authors commented on previous versions of the manuscript. All authors read and approved the nal manuscript. Overview of all aspects of the CoCare Intervention

Supplementary Files
This is a list of supplementary les associated with this preprint. Click to download. AdditionalFile1InterviewguidelineCoCare.pdf AdditionalFile2Codingsystem.pdf