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Abstract Background Delirium is a neuropathological syndrome that is characterised by fluctuating impairments in attention, cognitive performance, and consciousness. Since delirium represents a medical emergency, it can be associated with adverse clinical and economic outcomes. Although nursing home residents face a high risk of developing delirium, health care professionals in this field appear to have limited knowledge of delirium despite the critical role they play in the prevention, diagnosis, and treatment of delirium in nursing homes. Objective The purpose of this realist review is to develop an initial programme theory with the goal of understanding how, why, and under what circumstances educational interventions can improve the delirium-specific knowledge of health care professionals in nursing homes. Methods This realist review was conducted in accordance with the RAMESES (Realist And Meta-narrative Evidence Synthesis: and Evolving Standards) guidelines and includes the following steps: (1) search strategy and literature review; (2) study selection and assessment; (3) data extraction; (4) data synthesis; and (5) development of an initial programme theory. It also included stakeholder discussions with health care professionals recruited from nursing home care, which focused on their experiences with delirium. Results From a set of 1703 initially identified publications, ten publications were included in this realist review. Based on these publications, context-mechanism-outcome configurations were developed; these configurations pertained to (1) management support, (2) cognitive impairments among residents, (3) familiarity with residents, (4) participatory intervention development, (5) practical application, (6) case scenarios, (7) support from experts and (8) relevance of communication. Conclusions Educational interventions aimed at improving the delirium-specific knowledge of health care professionals should feature methodological diversity if they are to enhance health care professionals’ interest in delirium and highlight the fundamental contributions they make to the prevention, diagnosis, and treatment of delirium. Educational interventions should also take into account the multidimensional contextual factors that can have massive impacts on the relevant mode of action as well as the responses of health care professionals in nursing homes. The identification of delirium in residents is a fundamental responsibility for nursing home staff. Trial registration This review has been registered at Open Science Framework https://doi.org/10.17605/OSF.IO/6ZKM3

Introduction The prevalence of mental health problems is increasing worldwide, particularly in the vulnerable group of older people. The limited availability of therapists, long wait periods and increasing shortage of healthcare resources limit adequate care. As a result, digital applications are becoming more commonplace as an alternative to human therapists. However, these tend to be used by younger people with higher education, digital health literacy and experience. In Germany, applications that are approved by the health authorities, so-called digital health applications (DiGAs), can be prescribed by physicians and psychotherapists. It remains unclear to the extent older people are experienced with, are willing and can use a DiGA. Therefore, this research aims to identify specific challenges of older people’s accessibility, user experience and engagement with DiGA for depressive disorders. The DiGA4Aged project consists of: (1) a pilot study on usability, (2) a screening study on potential participants for a randomised controlled trial (RCT) evaluating the digital experience of the target population and (3) an RCT to test the effectiveness of a digital nurse as individualised user support in the intervention group. This paper focuses on the pilot study and the screening study.Methods and analysis The instrumental components in preparing for the RCT are a mixed-method pilot and observational quantitative screening study, which are described in this manuscript. The pilot study includes questionnaires (covering sociodemographic data, user experience, health literacy, electronic health literacy, media affinity, severity of depression and perceived usability of DiGA), a concurrent think aloud method and a semistructured interview to evaluate two applications with regard to their usability for, acceptance by and needs of older people. The observational screening study collects data of older patients consecutively admitted to an acute care geriatric hospital ward using various questionnaires to identify which clinical and medical factors are associated with the access to, experience with and (non-)use of digital media. Data from the comprehensive geriatric assessment is collected as well as data on their digital media experience and digital health literacy.Ethics and dissemination The overall project DiGA4Aged received ethical approval on 17 November 2023 from the ethics committee of the Medical Faculty of Ruhr-University Bochum (registration number 23-7901). Results will be disseminated within the scientific community via publication in peer-reviewed journals as well as presentation at national conferences. The findings from the pilot study and the observational screening study will determine the selection of the DiGA and the recruitment strategy for the subsequent RCT.Trial registration numbers The pilot study has been prospectively registered in the German Clinical Trials Register (DRKS00033640, registered on 18 March 2024, available from https://drks.de/search/de/trial/DRKS00033640). Likewise, the observational screening study has been prospectively registered in the German Clinical Trials Register (DRKS00032931, registered on 29 November 2023, available from https://drks.de/search/de/trial/DRKS00032931).

Introduction Germany and the European Union have experienced successive waves of refugees since 2014, resulting in over 1.6 million arrivals, including families with young children. These vulnerable populations often face xenophobia, discrimination, substandard living conditions and limited healthcare access, contributing to a high prevalence of mental health problems (MHP). Our primary goal is to proactively address MHP in refugee parents and prevent its potential impact on their children through effective early interventions. Using a low-threshold, primary care-based approach, we aim to enhance parenting skills and address parental psychopathology, creating a supportive environment for parents and children.Methods and analysis In this randomised controlled trial, 188 refugee parents of 6-year-old children or younger who meet the clinical cut-off on the MHP scale will participate. They are randomly assigned to either the experimental psychotherapeutic intervention, delivered by general practitioners (10-week Improve intervention), or treatment as usual, in a ratio of 1:1. The randomisation will be masked only for outcome assessors. Improve includes face-to-face sessions with general practitioners, an interactive online parenting programme (Triple P Online) and regular protocol-based telephone calls by psychologists. Primary outcomes will assess the intervention’s effects on parental and child MHP and parenting skills, with secondary outcomes including psychosocial and physical health indicators. Outcomes will be assessed at pre, post and at 3-month and 6-month follow-ups. The study is scheduled to run from February 2019 to July 2025.Ethics and dissemination The project Improve-MH (application number 602) was approved by the local ethics committee of Ruhr-University of Bochum and is being conducted in accordance with the Declaration of Helsinki. The study is also conducted in full accordance with the German Data Protection Act, and the Good Clinical Practice guideline (GCP) and is sensitive to specific ethical considerations. Results will be disseminated at scientific conferences, published in peer-reviewed journals and provided to consumers of healthcare.Trial registration number The trial was prospectively registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS-ID: DRKS00019072) on 16 March 2020.

Abstract Background The rates of coronary angiograms (CA) and related procedures (percutaneous intervention [PCI]) are significantly higher in Germany than in other Organisation for Economic Co-ordination and Development (OECD) countries. The current guidelines recommend non-invasive diagnosis of coronary heart disease (CHD); CA should only have a limited role in choosing the appropriate revascularisation procedure. The aim of the present study was to explore whether improvements in guideline adherence can be achieved through the implementation of regional treatment pathways. We chose four regions of Germany with high utilisation of CAs for the study. Here we report the results of the concomitant qualitative study. Methods General practitioners and specialist physicians (cardiologists, hospital-based cardiologists, emergency physicians, radiologists and nuclear medicine specialists) caring for patients with suspected CHD were invited to develop regional treatment pathways. Four academic departments provided support for moderation, provision of materials, etc. The study team observed session discussions and took notes. After the development of the treatment pathways, 45 semi-structured interviews were conducted with the participating physicians. Interviews and field notes were transcribed verbatim and underwent qualitative content analysis. Results Pathway development received little support among the participants. Although consensus documents were produced, the results were unlikely to improve practice. The participants expressed very little commitment to change. Although this attempt clearly failed in all study regions, our experience provides relevant insights into the process of evidence appraisal and implementation. A lack of organisational skills, ignorance of current evidence and guidelines, and a lack of feedback regarding one’s own clinical behaviour proved to be insurmountable. CA was still seen as the diagnostic gold standard by most interviewees. Conclusions Oversupply and overutilisation can be assumed to be present in study regions but are not immediately perceived by clinicians. The problem is unlikely to be solved by regional collaborative initiatives; optimised resource planning within the health care system combined with appropriate economic incentives might best address these issues.

Abstract Introduction After being diagnosed with dementia, patients need a medical professional to empathetically address their fears and get initial questions answered. This scoping review therefore addresses how patients newly diagnosed with dementia are cared for in the general practitioner (GP) setting and how the communication between different healthcare professionals and the GP is handled. Methods The scoping review was conducted based on the PRISMA Extension for Scoping Reviews checklist. After developing a search algorithm, literature searches were performed in PubMed, Scopus, Web of Science, Cochrane Library, PsychInfo, GeroLit and Cinahl using defined search criteria, such as a focus on qualitative study designs. After the removal of duplicates, title/abstract and full text screening was carried out. Results Final data extraction included 10 articles out of 12,633 records. Strategies regarding the post-acute care of newly diagnosed patients included providing clarity and comfort to the patients and giving support and information both pre- and post-diagnosis. Care efforts were focused on advanced care planning and deprescribing. Involving people with dementia and their caregivers in further care was seen as crucial to provide them with the support needed. GPs emphasised the importance of listening to concerns, as well as ensuring wishes are respected, and autonomy is maintained. All studies found communication between the GP setting and other healthcare professionals regarding post-acute care to be inadequate. Lack of information sharing, clinical notes and recommendations for the GP setting resulted in inefficient provision of support, as GPs feel limited in their ability to act. Discussion Sharing necessary information with the GP setting could promote patient-centred care for people living with dementia and facilitate appropriate and timely resource allocation and effective healthcare collaboration between the settings, for example, by defining clear care pathways and clarifying roles and expectations.

BackgroundPrimary care research networks can generate important information in the setting where most patients are seen and treated. However, this requires a suitable IT infrastructure (ITI), which the North Rhine-Westphalian general practice research network is looking to implement. ObjectiveThis mixed methods research study aims to evaluate (study 1) requirements for an ITI and (study 2) the usability of an IT solution already available on the market, the FallAkte Plus (FA+) system for the North Rhine-Westphalian general practice research network, which comprises 8 primary care university institutes in Germany’s largest state. MethodsIn study 1, a survey was conducted among researchers from the institutes to identify the requirements for a suitable ITI. The questionnaire consisted of standardized questions with open-ended responses. In study 2, a mixed method approach combining a think-aloud approach and a quantitative survey was used to evaluate the usability and acceptance of the FA+ system among 3 user groups: researchers, general practitioners, and practice assistants. Respondents were asked to assess the usability with the validated system usability scale and to test a short questionnaire on vaccination management through FA+. ResultsIn study 1, five of 8 institutes participated in the requirements survey. A total of 32 user requirements related primarily to study management were identified, including data entry, data storage, and user access management. In study 2, a total of 36 participants (24 researchers and 12 general practitioners or practice assistants) were surveyed in the mixed methods study of an already existing IT solution. The tutorial video and handouts explaining how to use the FA+ system were well received. Researchers, unlike practice personnel, were concerned about data security and data protection regarding the system’s emergency feature, which enables access to all patient data. The median overall system usability scale rating was 60 (IQR 33.0-85.0), whereby practice personnel (median 82, IQR 58.0-94.0) assigned higher ratings than researchers (median 44, IQR 14.0-61.5). Users appreciated the option to integrate data from practices and other health care facilities. However, they voted against the use of the FA+ system due to a lack of support for various study formats. ConclusionsUsability assessments vary markedly by professional group and role. In its current stage of development, the FA+ system does not fully meet the requirements for a suitable ITI. Improvements in the user interface, performance, interoperability, security, and advanced features are necessary to make it more effective and user-friendly. Collaborating with end users and incorporating their feedback are crucial for the successful development of any practice network research ITI.

Abstract Background Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled “Prevention by lay-assisted Outdoor-Walking in the Elderly at Risk” POWER-study investigates whether volunteer-supported outdoor-walking improves physical function and quality of life in older people living independently or in nursing homes. This sub-study explores the experiences of older participants and volunteers in relation to their physical and psychosocial well-being as well as the challenges faced by both groups. A further aim was to explore volunteers’ experience with people living in nursing homes during the first pandemic lockdown (spring 2020). Methods The sub-study was designed as mixed-methods approach consisting of 11 individual semi-structured guide-based interviews (nursing home residents), two focus group interviews (volunteers), and a cross-sectional questionnaire survey (volunteers). The interviews were audiotaped, transcribed verbatim, and analyzed by content analysis as described by Kuckartz. Topics addressed in the interviews were triangulated by means of a questionnaire. The quantitative data were analyzed using descriptive statistics. Results Participants’ evaluation of the intervention was generally positive. Nursing home residents appreciated the social interaction associated with the assisted walking, which motivated them to take part regularly, provided a sense of safety, and caused pleasure on both sides. The impact on physical health status of the nursing home residents of this sub-study varied to a large degree as reported in interviews: in some cases, an improvement in physical performance, a decrease in physical complaints, and an improvement in gait or independence was reported. If not, reference was made to previous or sudden illnesses and the advanced age of the participants. Despite the COVID-19-lockdown and the associated restrictions, about 60% of contacts were still possible and participants planned to continue the assisted walks after the lockdown. Conclusion Volunteers have a positive effect on the quality of life, mobility, and general health of nursing home residents. Even more than the improvement of physical performance, social interaction was seen as helpful. Despite their advanced age, the nursing home residents were curious and open to new contacts. When removing the identified barriers, it might be possible to integrate this program into the long-term everyday life of nursing homes. Trial registration DRKS-ID: DRKS00015188, date of registration: 31.08.2018.

BackgroundArtificial intelligence (AI), conceived in the 1950s, has permeated numerous industries, intensifying in tandem with advancements in computing power. Despite the widespread adoption of AI, its integration into medicine trails other sectors. However, medical AI research has experienced substantial growth, attracting considerable attention from researchers and practitioners. ObjectiveIn the absence of an existing framework, this study aims to outline the current landscape of medical AI research and provide insights into its future developments by examining all AI-related studies within PubMed over the past 2 decades. We also propose potential data acquisition and analysis methods, developed using Python (version 3.11) and to be executed in Spyder IDE (version 5.4.3), for future analogous research. MethodsOur dual-pronged approach involved (1) retrieving publication metadata related to AI from PubMed (spanning 2000-2022) via Python, including titles, abstracts, authors, journals, country, and publishing years, followed by keyword frequency analysis and (2) classifying relevant topics using latent Dirichlet allocation, an unsupervised machine learning approach, and defining the research scope of AI in medicine. In the absence of a universal medical AI taxonomy, we used an AI dictionary based on the European Commission Joint Research Centre AI Watch report, which emphasizes 8 domains: reasoning, planning, learning, perception, communication, integration and interaction, service, and AI ethics and philosophy. ResultsFrom 2000 to 2022, a comprehensive analysis of 307,701 AI-related publications from PubMed highlighted a 36-fold increase. The United States emerged as a clear frontrunner, producing 68,502 of these articles. Despite its substantial contribution in terms of volume, China lagged in terms of citation impact. Diving into specific AI domains, as the Joint Research Centre AI Watch report categorized, the learning domain emerged dominant. Our classification analysis meticulously traced the nuanced research trajectories across each domain, revealing the multifaceted and evolving nature of AI’s application in the realm of medicine. ConclusionsThe research topics have evolved as the volume of AI studies increases annually. Machine learning remains central to medical AI research, with deep learning expected to maintain its fundamental role. Empowered by predictive algorithms, pattern recognition, and imaging analysis capabilities, the future of AI research in medicine is anticipated to concentrate on medical diagnosis, robotic intervention, and disease management. Our topic modeling outcomes provide a clear insight into the focus of AI research in medicine over the past decades and lay the groundwork for predicting future directions. The domains that have attracted considerable research attention, primarily the learning domain, will continue to shape the trajectory of AI in medicine. Given the observed growing interest, the domain of AI ethics and philosophy also stands out as a prospective area of increased focus.

BackgroundElectronic health records (EHRs) are a promising approach to document and map (complex) health information gathered in health care worldwide. However, possible unintended consequences during use, which can occur owing to low usability or the lack of adaption to existing workflows (eg, high cognitive load), may pose a challenge. To prevent this, the involvement of users in the development of EHRs is crucial and growing. Overall, involvement is designed to be very multifaceted, for example, in terms of the timing, frequency, or even methods used to capture user preferences. ObjectiveSetting, users and their needs, and the context and practice of health care must be considered in the design and subsequent implementation of EHRs. Many different approaches to user involvement exist, each requiring a variety of methodological choices. The aim of the study was to provide an overview of the existing forms of user involvement and the circumstances they need and to provide support for the planning of new involvement processes. MethodsWe conducted a scoping review to provide a database for future projects on which design of inclusion is worthwhile and to show the diversity of reporting. Using a very broad search string, we searched the PubMed, CINAHL, and Scopus databases. In addition, we searched Google Scholar. Hits were screened according to scoping review methodology and then examined, focusing on methods and materials, participants, frequency and design of the development, and competencies of the researchers involved. ResultsIn total, 70 articles were included in the final analysis. There was a wide range of methods of involvement. Physicians and nurses were the most frequently included groups and, in most cases, were involved only once in the process. The approach of involvement (eg, co-design) was not specified in most of the studies (44/70, 63%). Further qualitative deficiencies in the reporting were evident in the presentation of the competences of members of the research and development teams. Think-aloud sessions, interviews, and prototypes were frequently used. ConclusionsThis review provides insights into the diversity of health care professionals’ involvement in the development of EHRs. It provides an overview of the different approaches in various fields of health care. However, it also shows the necessity of considering quality standards in the development of EHRs together with future users and the need for reporting this in future studies.

Background Delirium is a neuropathological condition that impairs cognitive performance, attention and consciousness and can be potentially life-threatening. Nursing home residents are particularly vulnerable to developing delirium, but research thus far tends to focus on the acute hospital setting. Healthcare professionals (HCPs) working in nursing homes seem to be little aware of delirium. To improve healthcare for affected or at-risk individuals, increasing knowledge among HCPs is highly relevant. Using the realist review method helps to understand how and why an educational intervention for HCPs on delirium in nursing homes works.Methods and analysis In accordance with the Realist And Meta-narrative Evidence Syntheses: Evolving Standards publication standards for realist syntheses, the review process will include the following five steps: (1) search strategy and literature review; (2) study selection and assessment; (3) data extraction; (4) data synthesis and (5) development of an initial programme theory. The literature search will be conducted in the databases Medline (PubMed), CINAHL (Ebsco), Scopus, Web of Science, GeroLit and Carelit. Additional focuses are on snowballing techniques, hand research and grey literature. Studies of any design will be included to develop the initial programme theory. The literature will be selected by two researchers independently. In addition, the experiences of HCPs from nursing homes will be reflected in group discussions. To this end, Context–Mechanism–Outcome configurations (CMOcs) will be established to develop an initial programme theory.Ethics and dissemination The results will be disseminated within the scientific community. For this purpose, presentations at scientific conferences as well as publications in peer-reviewed journals are scheduled. In the next step, the CMOcs could serve for the development of a complex educational intervention to increase the knowledge of HCPs on delirium in nursing homes.Registration details This protocol has been registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/HTFU4).

Objectives Strong primary care leaders are needed to assure high quality services for patient populations. This study analysed general practitioners’ (GP) leadership skills comparing practice-level self and staff assessments based on the full range of leadership model and the leader-member exchange (LMX).Setting The questionnaire survey was conducted among German general practice leaders and their staff participating in the IMPROVEjob trial.Participants The study population comprised 60 German general practices with 366 participants: 84 GP practice leaders and 282 employees (28 physicians and 254 practice assistants).Primary and secondary outcome measures Leadership skills of the practice leaders were measured using the Integrative Leadership Questionnaire (German Fragebogen für integrative Führung) and the LMX-7 questionnaire. Leaders rated themselves and practice staff rated their leaders. The data was analysed by paired mean comparisons on the practice level.Results For most leadership dimensions, practice leaders rated themselves higher than their employees rated them. Differences were found for transformational leadership (p

Influenza and pneumococcal vaccinations are recommended in the elderly to reduce life-threatening complications like sepsis. Protection may be reduced with increasing age. We aimed to assess the effectiveness of both vaccines in the elderly by performing a retrospective cohort study of 138,877 individuals aged ≥60 y in Germany, who were insured in a large statutory health insurance (AOK PLUS). We used longitudinal claims data to classify individuals according to vaccination status 2008–2014, and assessed vaccine effectiveness (VE) in 2015 and 2016. Inverse probability weighting based on generalized propensity scores was used to adjust for systematic between-group differences. Influenza vaccination was associated with a reduction of hospital treatment in laboratory-confirmed influenza in 2015 (VE = 41.32 [95%CI 0.85, 65.26]), but had no significant impact on the overall influenza incidence. Complications of influenza (pneumonia and sepsis) were reduced in 2016. We found a rise in influenza-like illness and acute respiratory infections in both years and an increased 90-d mortality after hospital-treated pneumonia in vaccinees in 2015. Pneumococcal vaccination was effective in preventing hospital-treated pneumonia within the first and second year after vaccination (VE = 52.45 [13.31, 73.92] and 46.04 [5.46, 69.21], respectively), but had no impact on sepsis incidence or pneumonia mortality. Influenza and pneumococcal vaccination can prevent severe complications from influenza and hospital-treated pneumonia in the elderly, respectively. Vaccine effects differ between years and seasons and are partly difficult to interpret. Despite extensive efforts to adjust for between-group differences, residual bias cannot be ruled out, possibly explaining signals like increased ILI or pneumonia mortality.

Hintergrund: Ähnlich der wenig qualitätsgesicherten Leitlinien Ende der 90er Jahre erlebt das deutsche Gesundheitssystem vor dem Hintergrund der Digitalisierung erneut eine Inflation an wenig qualitätsgesicherten Publikationen von digitalen Anwendungen. Vor diesem Hintergrund wird vielerorts eine schwache Evidenz von Gesundheits- und Medizin-Apps moniert. Um die Qualität von Studien und die Transparenz bei der Berichterstattung von Studien als Leistungserbringer und Anwendern einschätzen zu können, bedarf es gerade für Ärzte als auch Wissenschaftler einheitlicher Kriterien. Methodik: Im September 2019 und ergänzend im Februar 2020 wurde eine Literaturrecherche in PubMed sowie Google Scholar durchgeführt. Gesucht wurden Frameworks und Reporting Guidelines, die bei Evaluationen zu Gesundheits- und Medizin-Apps angewendet werden können. Als Vergleichskriterien wurden Framework, Phasen/Items, Methodik und Fokus gegenübergestellt und explorativ ausgewertet. Ergebnis: Es wurden sieben Publikationen zu Frameworks und Reporting Guidelines eingeschlossen. Diese unterscheiden sich in dem intendierten Fokus und dem Umfang sowie dem Inhalt der Bewertungskriterien. Die Frameworks und Reporting Guidelines adressieren Studien, die mit Gesundheits- und Medizin-Apps durchgeführt werden, wie z. B. das Mobile Health Evidence Reporting and Assessment (mERA) sowie den sog. DiGA-Leitfaden für das Fast-Track-Verfahren für digitale Gesundheitsanwendungen. Zudem sind methodenbezogene Reporting Guidelines hervorzuheben, welche primär einen methodischen Fokus auf die Anwendung legen, bspw. bei randomisiert kontrollierten Studien. Schlussfolgerung: Angesichts der in dieser Arbeit dargestellten Optionen von Standards in der Berichterstattung von digitalen Anwendungen konnte der vom BfArM vorgestellte Leitfaden um weitere Items erweitert werden, um Leistungserbringern und Anwendern mehr Sicherheit zu geben und gleichzeitig Abstriche im Qualitätsanspruch zu verhindern.

Abstract Background In the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen, Wettbewerb an der Schnittstelle zwischen ambulanter und stationärer Gesundheitsversorgung, 2012). However, there are shortcomings in these intersectoral transitions. Especially in older people with cognitive impairment (PCI), discharge management often lacks coordination and cooperation between healthcare providers. This frequently results in higher rates of unscheduled readmission. The project intersec-CM is a randomised controlled trial (RCT) that aims to explore up to what extent an intersectoral care management (ICM) can improve this transition. This ICM is delivered by nurses with special training in care management. The objective of this paper is to describe a mixed-methods process evaluation of the intersectoral care management intervention and the factors that facilitate and inhibit its implementation. Methods Different study designs for process evaluations from previous literature were collected and analysed according to the dimension implementation fidelity, satisfaction with the intervention, feasible transfer into routine care, optimum point of time, frequency and execution of the intervention, and context factors. Results The actor-network theory was chosen as the theoretic framework for the process evaluation. Based on this theory, a mixed-methods design was developed to combine and integrate qualitative and quantitative evaluation methods. The qualitative part includes semi-structured interviews using topic guides (phase 1) and later in-depth interviews with narrative portions (phase 3), which will be analysed by using the qualitative content analysis according to Kuckartz. The quantitative survey (phase 2) is conducted with standardised questionnaires. Discussion Challenges in data collection include the development of interview guidelines, which require different terminologies depending on every specific actor targeted in the intervention. Conducting the interviews, there is a risk of misunderstanding the older PCI by the interviewer and vice versa. However, the combination of qualitative and quantitative approaches as different techniques of process evaluation may help to capture, integrate and analyse data on different dimensions of the intervention. Conclusions The results of our process evaluation may serve as an implementation guideline for intersectoral care management in the German healthcare system. Furthermore, the approach to evaluate the process of a complex intervention in health care for older PCI may serve as a stimulus to broaden the evidence base also of other complex intervention studies to improve health care for this vulnerable group. The study was ethically approved by the Ethics Committee of the Ernst-Moritz-Arndt University of Greifswald. The study has been registered at the U.S. National Library of Medicine. Trial registration ClinicalTrials.gov NCT03359408 . Registered on 2 December 2017. The approximate date when recruitment to the process evaluation of the study will be completed is 31 May 2021.