Does the mode of care delivery affect therapeutic alliance, patient care satisfaction or patient reported outcomes? Psycho-oncological care evaluation data collected during the COVID-19 pandemic.

PURPOSE: Since the COVID-19 pandemic, psycho-oncological care has increasingly been provided virtually and/or telephonically. We examined whether patients' therapeutic alliance (TA) - an essential processual outcome - differs due to altered modes of care delivery (MOCD) and assessed, if MOCD impacts patients' care satisfaction and patient reported outcomes. METHODS: Survey and documentation data from newly diagnosed cancer patients that were cared for in the new form of care 'isPO' in Germany, were analyzed. Patients were surveyed after completing the one-year psycho-oncological care program. MOCD was operationalized by the ratio of patients' face-to-face, telephonic or video-based consultations to all their consultations. Regression analyzes were conducted to determine a possible relationship between MOCD and TA, between MOCD and patients' care satisfaction ('subjective effectiveness' and 'satisfaction and needs-orientation') and patient reported outcomes (anxiety and depression, sense of coherence, global health status). FINDINGS: MOCD does not significantly influence TA. Regression models on the possible effect on subjective effectiveness and satisfaction and needs-orientation do not show statistical significance with only MOCD as the predictor. MOCD does not predict any of the patient reported outcomes. CONCLUSIONS: During the pandemic, neither TA, care satisfaction nor patient reported outcomes were affected by the MOCD in the new form of care 'isPO'. Therefore, the MOCD didn't negatively affect quality of care, which indicates that telephone or video consultations seem to be useful alternatives for psycho-oncological care in Germany.

[Planning, Reflecting and Evaluating Participatory Health Research: Adaptation and Piloting of the "Community Based Participatory Research (CBPR) Model" for German-Speaking Countries]. / Partizipative Gesundheitsforschung planen, reflektieren und evaluieren: Die Adaption und Erprobung des "Community Based Participatory Research (CBPR) Model" für den deutschsprachigen Raum.

Participatory research approaches are becoming increasingly established in both academic and practice settings. The participation of people with varied lived experiences and professional backgrounds can help academia and practitioners to learn from and empower each other. In the exchange of different perspectives, needs and ideas, it is possible to plan, reflect on, implement and evaluate projects in the health sector jointly and with attention to the needs of all stakeholders. The Community Based Participatory Research (CBPR) Model is often used internationally to guide participatory processes. However, an accessible translation has been lacking for application in German-speaking countries. To address this problem, a multidisciplinary working group composed of academic researchers and practitioners came together within the German-speaking Participatory Health Research Network (PartNet) to adapt the CBPR model for German-speaking countries and to test the adapted version with potential users. The adaptation was more than a translation, as the four model components "Contexts", "Partnership Processes", "Intervention & Research" and "Outcomes" as well as their associated contents are not directly applicable to the socio-structural and political contexts of the German-speaking countries. This article describes the process of adapting the model. This includes how translation drafts for German-speaking countries were first discussed in detail and then agreed upon as an initial template for testing in practice. Subsequently, various users reflected on the German-language model based on their experience of testing it in different projects, focusing on accuracy, comprehensibility and applicability. At the same time, the model was presented and discussed at conferences. The diverse feedback was incorporated into further revisions of the model. The result is a German-language version called "Modell für partizipative Gesundheitsforschung (PGF-Modell)".

Patients' perspectives on the quality of care of a new complex psycho-oncological care programme in Germany - external mixed methods evaluation results.

BACKGROUND: Guideline-compliant provision of psycho-oncological (PO) care is still challenging in Germany. Hence, a new care programme, called integrated cross-sectoral psycho-oncology (isPO), was implemented to improve the integration of needs-oriented PO care. Quality of care (QoC) was externally evaluated from the patient's perspective. We aim to gain insight into patients' experiences with isPO and how their assessment affects relevant patient-reported outcomes (anxiety and depression, health status, and work ability). METHODS: An explanatory, sequential mixed-methods design was applied. Patients were surveyed twice during their 1-year care trajectory: after 3 (T1) and 12 (T2) months. Data sets were matched using pseudonyms. Care documentation data, including sociodemographic characteristics and the primary outcome variable (anxiety and depression), were matched. In the survey, patients rated their satisfaction with respective isPO service providers and the programme in general (QoC). Health status (EORTC-QLQ-C30) and work ability (WAS) were measured. Descriptive analyses and t-tests for dependent samples were conducted to assess changes in outcome variables over time. Linear regression analyses were conducted to assess whether care satisfaction predicted outcome variables. Patients who completed their isPO care trajectory were asked to participate in semi-structured telephone interviews to share their experiences. Purposeful sampling was applied. All 23 interviews were audiotaped, transcribed, and analysed via content-structuring method. RESULTS: Patients reported medium-to-high satisfaction with their isPO care. All patient-related outcomes significantly improved over time and QoC measures predicted those outcomes. Needs orientation (e.g., care intensity or mode of delivery) was perceived as essential for high QoC, and outpatient care with fixed contact persons as highly important for care continuity. Furthermore, patients identified programme optimisation needs, such as period of care or extension of care to relatives. CONCLUSIONS: Patients assessed the isPO programme's QoC positively. They identified facilitators for QoC and optimisation needs. Therefore, data on QoC can function as an indicator for a programme's feasibility and maturity within care reality. As patients' care satisfaction positively influences important patient-related outcomes, it may be routinely considered for quality management. Based on patients' perspectives, isPO seems to be recommendable for routine psycho-oncological care in Germany, if ongoing programme optimisation within structured quality management is guaranteed. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (No. DRKS00015326) on 30.10.2018.

Integrating one-to-one peer support into psycho-oncological care in Germany: multi-perspective, mixed-methods evaluation of the isPO onco-guide service.

PURPOSE: One-to-one peer supporters called isPO onco-guides (isPO OGs) are an integral part of the new German psycho-oncological form of care 'integrated, cross-sectoral Psycho-Oncology' (isPO), additionally to professional care. The isPO OGs are cancer survivors with experiential knowledge, offering information on local support services and answering questions 'all around cancer' to newly diagnosed cancer patients. We aimed to evaluate the isPO OG service from three perspectives: patients, isPO OGs, and professional service providers. METHODS: A mixed-methods approach was pursued. We conducted interviews and focus groups with the three person groups, and applied qualitative content analysis on the reported resources, processes and outcomes regarding the isPO OG service. Relations with patients' utilisation and isPO OGs' work satisfaction were identified with regression and correlation analyses of questionnaire and isPO care data. We compared isPO care networks (CN) with X2-tests or ANOVA. Qualitative and quantitative results were integrated during interpretation phase. RESULTS: Qualitatively, the three person groups agreed on the benefits of the isPO OG service. The implementation's maturity differed between the CN concerning established processes and resource availability. Attitudes of professional service providers appeared to be crucial for patients' utilisation of the isPO OG service. Quantitative results emphasised the differences between the CN. CONCLUSION: Beyond differences in the CN, the isPO OG service has two psychosocial benefits: providing relevant, reliable, and understandable information; and offering the encouraging example that surviving and living with cancer is possible. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (No. DRKS00015326) on 30.10.2018.

The impact of COVID-19 on the interpretation of psycho-oncological support trial results: a quasi-experimental approach using the data from the new form of care "Integrated cross-sectoral psycho-oncology (nFC-isPO)".

OBJECTIVE: In addition to the common difficulties of ongoing trials, the COVID-19 pandemic posed several challenges to scientists worldwide and created an additional burden for vulnerable patient groups. In the nFC-isPO of individualised treatment for anxiety and depression in newly diagnosed patients with cancer caregivers (e.g. psycho-oncologists) reported elevated HADS scores in newly enrolled patients after the outbreak of the COVID-19 pandemic. Accordingly, the question arises whether the pandemic affected HADS scores. Therefore, stratified analyses by the time of enrolment (T1) were performed for patients with 12 months of care (T3). METHODS: Patients with 12 months of care (N = 1,140) were analysed. A comparison within the regression discontinuity design according to the time points at which patients completed the baseline (T1) HADS questionnaire was conducted to examine differences between patients recruited before Q2/2020 (pre-pandemic) and after the coronavirus outbreak. Furthermore, mean HADS scores at T1 and T3 for all quarters during the study were compared. RESULTS: Mean T1 and T3 HADS scores of patients with cancer during the pandemic are only slightly higher than those of the pre-pandemic group. No significant treatment effect was observed in either the pre-pandemic (p = 0.5495, Late = 1.7711) or the post-pandemic group (p = 0.9098, LATE=-0.2933). In contrast, the average local treatment effect in the post-pandemic group suggests a minimal decrease in HADS score in the predefined range and thus a positive treatment effect for isPO. Comparison of mean HADS scores at T1 and T3 did not show a large increase by pandemic-related timepoints, however, a decrease of approximately 2-3 points over each quarter at 12 months compared to baseline is observed. CONCLUSION: The existing nFC-isPO care is resilient to crisis and may counteract external influences such as the Corona pandemic. Accordingly, the pandemic had little influence on the fears of patients with cancer in the nFC-isPO. This emphasises that psycho-oncology is vital for the reduction of stress, anxiety and depression in patients with cancer. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry on 30 October 2018 under the ID "DRKS00015326".

Cancer patients' experiences and preferences when receiving bad news: a qualitative study.

PURPOSE: Receiving a cancer diagnosis significantly impacts patients' lives, and how the bad news is delivered influences patients' trajectory, psychosocial adjustment and openness to psycho-oncological support. We explored how patients' experiences, reactions and preferences were when receiving the news and which optimization recommendations can be made. METHODS: We conducted an exploratory qualitative study with patients who enrolled in the new integrated cross-sectoral psycho-oncological care programme 'isPO', being enrolled 12 months post-diagnosis. Data on the main issue (i.e. perception of the moment when the diagnosis is received) were collected via telephone interviews that were fully audiotaped and transcribed. Two independent coders conducted inductive content analyses using MAXQDA. RESULTS: Out of 38 approached patients, 23 cancer patients with 13 different tumour entities participated. They had a mean age of 54.2 (SD 16.2); n = 17 (74%) were female. Three major themes with 14 corresponding subthemes emerged: (1) patients' experiences with the bad news delivery, including setting, mode, preparation and perceived needs; (2) patients' reactions to the bad news, such as shock, fear and helplessness, disbelief and denial, anger and feeling of injustice, thankfulness and depression; and (3) patients' receiving preferences, including psycho-oncological support, addressing informational needs, needs-driven comprehensive support and a competent multidisciplinary support team. CONCLUSIONS: The quality of bad news delivery and addressing patients' needs should be strongly considered by physicians. We recommend integrating patients' perspective on the quality management processes of breaking bad news. For providing needs-centred high-quality care, applying existing guidelines and acquiring patient-centred communication skills are central.

Cognitive training for older prisoners: a qualitative analysis of prisoners' and staff members' perceptions.

Introduction: Correctional institutions are challenged by increasing numbers of older prisoners. Existing literature highlights the vulnerability of this group that is reflected by various somatic and mental health issues including cognitive dysfunctions. Although cognitive training studies in various target groups of older people have been conducted, there is lack of data regarding cognitive training in older prisoners. A structured cognitive group training program ("NEUROvitalis Prison") with 12 weekly sessions was offered to male prisoners in Germany. Methods: Post intervention an exploratory qualitative study was conducted. Prisoners (N = 18) and staff (N = 4) perspectives were explored by conducting face-to-face semi-structured interviews. Audiotaped data were fully transcribed and deductive-inductive content analyses applied. Results: Both the prisoners and the staff perceived the cognitive training as very positive and stimulating. Moreover, the importance of the training was pronounced in terms of an increase in self-esteem and understanding of cognition and aging in the prisoners. Discussion: Our data indicate that cognitive training may be a feasible and valuable intervention for older prisoners that will be appreciated by both inmates and staff. The qualitative data provide substantial insight into the experiences with the applied cognitive training program. Moreover, valuable modifications for future conduct can be derived.

Conducting a prospective evaluation of the development of a complex psycho-oncological care programme (isPO) in Germany.

BACKGROUND: Evaluating the development phase of a complex intervention programme can be challenging. A prospective evaluation approach is presented based on the example of the new complex psycho-oncological care programme isPO (integrated, cross-sectoral Psycho-Oncology). Prior to programme implementation, we examined (1) if isPO was developed as intended, and (2) if it was relevant and transferable into the newly developed psycho-oncological care networks in North-Rhine Westphalia, Germany. Further, we investigated which implementation facilitators and barriers were anticipated and which implementation strategies were planned by the programme designers (multidisciplinary professionals and cancer supporting organizations who developed the isPO programme components and the networks). METHODS: A mixed-methods approach was applied. Qualitative data were collected by quarterly progress reports, interviews and a focus group with the programme designers. Evaluation criteria for document analyses of the quarterly progress reports were developed and applied. Content analysis was applied for analysing interviews and focus group. Quantitative data were gained from evaluating the programme training for the isPO service providers by short written questionnaires that were analysed descriptively. RESULTS: An implementable prototype of the isPO programme has been developed within 15 months, however no piloting was conducted. The programme's complexity proved to be challenging with regard to coordination and communication of the numerous programme designers. This was intensified by existing interdependencies between the designers. Further, there was little communication and participation between the programme designers and the prospective users (patients and service providers). Due to these challenges, only context-unspecific implementation strategies were planned. CONCLUSION: The required resources for developing a new complex care programme and the need of a mature implementation strategy should be sufficiently addressed. Programmes may benefit from prospective evaluation by gaining insightful knowledge concerning the programme's maturity and anticipating implementation facilitators and barriers. A mixed-methods evaluation design was crucial for achieving profound insight into the development process. TRIAL REGISTRATION: The study has been registered in the German Clinical Trials Register (No. DRKS00015326 ) on 30.10.2018.

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

Salutogenesis at Work as a Facilitator for Implementation? An Explorative Study on the Relationship of Job Demands, Job Resources and the Work-Related Sense of Coherence within a Complex Healthcare Programme.

BACKGROUND: The implementation of complex healthcare programmes can be challenging for respective service providers (SPs) in implementation settings. A strong work-related sense of coherence (Work-SoC) promotes creation of job resources and potentially facilitates coping with demands that may arise during implementation. In this study, we analyse how SPs' Work-SoC is influenced by job resources and demands during programme implementation and identify relevant implementation strategies to ensure a salutogenic implementation process. METHODS: Qualitative data were collected during the implementation of a new complex psycho-oncological care programme called isPO. Four focus groups and four interviews were conducted with SPs. All were audiotaped, transcribed and content analysis was applied, whilst ensuring inter- and intra-rater reliability. RESULTS: Each Work-SoC component was influenced by specific job resources and demands. In particular, comprehensibility and manageability interacted. Manageability affected assessment of the programme's feasibility. High meaningfulness positively affected the programme's acceptance and overall assessment among SPs. Furthermore, it buffered low manageability and was strongly associated with project identification. CONCLUSION: We found that Work-SoC could be used to assess SPs' work environment, and therefore programme feasibility. It may be worthwhile to use Work-SoC as an implementation outcome or as an indicator for possible programmes.

Optimizing Patient Information Material for a New Psycho-Oncological Care Program Using a Participatory Health Research Approach in Germany.

High-quality patient information material (PIM) is essential for patients´ informed decision-making, and its quality may influence a care program's acceptance. In the new psycho-oncological care program, isPO, the initial PIM was developed top-down and required optimization. In this paper, we report on the process and experiences of optimizing PIM's quality bottom-up by applying a Participatory Health Research (PHR) approach. Cancer-patient representatives of the national peer-support group contributed as co-researchers as part of the optimization team. A mixed-methods design was chosen. First, the quality of the initially utilized PIM was assessed with the newly designed user-friendly instrument UPIM-Check. Next, three Participatory Action Research loops were conducted, including cancers survivors and isPO service providers. The initial isPO PIM's were assed to be of low quality, limited usability and incomplete. Bottom-up generated optimization suggestions led to the improvement of two initially used PIMs (leaflet, patient information folder) and the design of two new PIMs (poster, study information overview). The optimized PIM facilitates isPO service providers' care provision and helps newly diagnosed cancer patients in understanding and accepting the new program. PIM optimization benefited from applying PHR. The patient representatives' contribution and active patient engagement were central for quality assessment and designing needs-driven, mature and complete PIM.

Designing a Patient-Friendly Website for Newly Diagnosed Cancer Patients with the Participatory Health Research Approach.

High-quality and user-friendly patient information material (PIM) is essential for understanding and accepting a new care programme. When optimising the PIM of the integrated, cross-sectoral psycho-oncological (isPO) care programme, the design of the fifth element of the patient information strategy-the patient-friendly website-was still pending. In this paper, the iterative design process of the patient-friendly isPO website is described. We applied the participatory health research (PHR) approach to enable high levels of participation of its respective end-users (e.g., cancer survivors), service providers, and experts. The design included six steps: (1) initiation, (2) planning, (3) initial idea exploration, (4) creation of a first working version, (5) three optimisation loops, and (6) dissemination. An exploratory mixed-methods design has been used. Qualitative data collection included document analysis, interviews, and participatory action research (PAR) loops with focus groups. Finally, the quality of the newly designed website was quantitatively assessed with the UPIM-Check, a user-friendly instrument for assessing and optimising PIM. The PHR approach was indispensable for the design of our needs-oriented, patient-friendly website. Participants' high levels of participation strongly contributed to the products' quality. The final descriptive statistical evaluation shows that the final website was rated very good on average by its end-users.

Participatory Development and Preliminary Psychometric Properties of the User-Friendly Patient Information Material Checklist (UPIM-Check).

The aims of this study were (1) to design a user-friendly instrument to assess and optimize patient information material (PIM), (2) to develop an English version, and (3) to test its psychometric properties. The instrument was needed to optimize the top-down developed PIM of the psycho-oncological care programme isPO. First, a literature-based PIM checklist was developed by a team of patient representatives, cancer care experts and professional researchers. Next, the checklist's reliability and validity were analysed by having cancer survivors assess the initial and optimized version of the isPO-leaflet. The User-friendly Patient Information Material Checklist (UPIM-Check), developed participatorily, was found to be effective for evaluating PIM. It uses a traffic light scale, and suggestions for improvement can be given for each criterion. Its reliability appeared to be excellent (α = 0.927). The optimized leaflet was rated significantly better than the initial one. The UPIM-Check is a reliable and valid instrument, which enables end-users (e.g., patients) to assess and optimize the quality of PIM according to scientific criteria and the needs of end-users. A bottom-up approach was essential for developing and validating the UPIM-Check. End-users constantly contributed with their specific knowledge. Thus, their position as co-researchers was significantly strengthened.

Caring for Family Caregivers of Geriatric Patients: Results of a Participatory Health Research Project on Actual State and Needs of Hospital-Based Care Professionals.

Because of societal changes, family caregivers are becoming vital in long-term care provision for geriatric patients after discharge from hospital. Hospital-based geriatric care teams need tools to prepare and support family caregivers for their future caregiving role in the home environment. To explore the actual state and needs for implementing a suitable family caregiver support concept in a large geriatric hospital in Germany, a Participatory Health Research methodology was chosen. An academic investigator, assisted by a critical friend, facilitated all research steps. Geriatric care professionals joined as co-researchers and performed qualitative data collection using semi-structured interviews and focus group discussions. The entire co-research team took part in the thematic analyses. The existing family caregiver support was perceived as uncoordinated and incomplete, and a lack of knowledge about support programmes in the community was apparent. The needs regarding a comprehensive family caregiver support concept that acts on both individual caregiver as well as on system level, but also connects the two levels, were formulated. High grades of participation of hospital-based co-researchers could be achieved. A critical reflection on the research strategy revealed that the participatory methodology, although time-consuming, was perceived as a useful strategy within the hierarchically organized hospital.

The development of implementation management instruments for a new complex stroke caregiver intervention based on systematic stakeholder and risk analyses.

BACKGROUND: Stakeholders are important contributors in the implementation of a complex public health intervention. During the development phase of an implementation, alongside careful design of its components and investing in the exploration of the dynamic multi-stakeholder stroke rehabilitation setting, it is essential to assess possible implementation risks. Systematic stakeholder and risk analyses can guide the exploration process and enable teams involved in complex interventions to develop context-tailored implementation management instruments. PURPOSE: To develop instruments that facilitate the implementation of the complex stroke caregiver intervention project in the real-life support system. METHODS: Systematic stakeholder and risk analyses were conducted composing five activities. Project stakeholders were identified, classified and assessed using a top-down approach, while implementation risks were identified and assessed by applying a bottom-up approach. Data were collected through interviews and focus groups. RESULTS: Based on the knowledge provided by the stakeholders, two context-tailored implementation management instruments were designed with a top-down approach: (1) a comprehensive 'stakeholder-risk atlas' providing individual stakeholder information, such as role, access, contribution, power and interest, expectations, perceived risks and specific engagement activities and (2) an overall 'project implementation strategy' concentrating on communication, transparency, network building and professionalism. CONCLUSION: Complex interventions will benefit from early and comprehensive stakeholder and risk analyses. The early involvement of stakeholders, with their insightful knowledge, enables the research team to develop context-tailored implementation management instruments. Instruments will support the team during implementation and may impact positively on the outcome of the intervention. Knowledge can be obtained by combining top-down and bottom-up working approaches.

Contextual Exploration of a New Family Caregiver Support Concept for Geriatric Settings Using a Participatory Health Research Strategy.

Family caregivers are the backbone of the long-term care support system within the home environment. Comprehensive caregiver support programs require collaboration and coordination within the system. A new public health concept, Vade Mecum, aims to harmonize and professionalize family caregiver support initiatives in geriatric care settings in the Euregion Maas-Rhine. Exploration of the new concept recently started in Germany to gain in-depth insight into current support and the needs of the geriatric care team and family caregivers. Within the context of an exploratory qualitative study, a participatory health research (PHR) strategy was applied to make optimal use of experience and knowledge from the system. Care professionals, engaged as co-researchers, were responsible for decisions about the research question, data collection methods and procedures of engaging family caregivers. A research team representing all professions within the geriatric department was formed. Research objectives were formulated and an appropriate mix of qualitative data collection methods consisting of interviews, focus groups and story-telling was chosen. Needs and expectations of the new concept, and practical solutions for involving family caregivers were discussed. A PHR strategy resulted in initiating a qualitative study in a geriatric care setting carried out by care professionals from the department. Knowledge was generated in a co-creative manner, and co-researchers were empowered. A comprehensive understanding of the system serves as a starting point for advancement of the new family caregiver concept.

Developing a complex intervention programme for informal caregivers of stroke survivors: The Caregivers' Guide.

BACKGROUND: Stroke affects the entire family system. Failure to meet the needs of caregivers leads to physical and mental overburdening. Stroke caregivers may benefit from professional support. The literature reviews have shown that there is still no clarity concerning the most appropriate set-up of a support programme. In Germany, there is no stroke caregiver support programme that operates throughout the course of rehabilitation. AIM: The aim was to develop a complex intervention programme for stroke caregivers in North-Rhine Westphalia, Germany. METHODS: A naturalistic enquiry approach, using a mixed-methods design, was applied. Within one overarching qualitative study, three separate, explorative, inductive, qualitative substudies were conducted: (i) seven explorative interviews with experienced stroke caregivers, (ii) six semi-structured interviews with professionals working within stroke rehabilitation and (iii) seventeen participant observations with focus on professional-caregiver interactions. Regional stroke units, rehabilitation centres, outpatient services and the home environment of caregivers were included. By means of a four-step qualitative content analysis, all three data sets were coded, categorised and subsequently condensed into subthemes, clustered into main themes, and finally translated into 'Conceptual Building Blocks' of the programme. RESULTS: The need for a personalised, holistic and multicomponent caregiver support programme emerged from all three substudies. Fourteen themes were condensed from the subthemes. Caregivers should be approached directly after stroke using outreach counselling. Support should be provided by a specially trained focal person across the entire patient's rehabilitation trajectory. The newly developed support programme consists of five flexible 'Conceptual Building Blocks': Content, Human Resources, Personalised Approach, Timing and Setting. CONCLUSION: Through a qualitative mixed-methods design, an in-depth contextual understanding of stroke caregiver needs within the rehabilitative support system was reached. This allowed the development of a context tailored comprehensive caregiver support programme consisting of five 'Conceptual Building Blocks'.