Development of a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers: A multi-method study.

BACKGROUND: Delirium is a common yet challenging condition in older hospitalized patients, associated with various adverse outcomes. Environmental factors, such as room changes, may contribute to the development or severity of delirium. Most previous research has focused on preventing and reducing this condition by addressing risk factors and facilitating reorientation during hospital stay. OBJECTIVE: We aimed to systematically develop a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers during and after these procedures. The intervention combines stakeholder and expert opinions, evidence, and theory. This article provides guidance and inspiration to research groups in developing complex interventions according to the recommendations in the Medical Research Council framework for complex interventions. DESIGN AND METHODS: A stepwise multi-method study was conducted. The preparation phase included analysis of the context and current practice via focus groups. Based on these results, an expert workshop was organized, followed by a Delphi survey. Finally, the intervention was modeled and a program theory was developed, including a logic model. RESULTS: A complex intervention was developed in an iterative process, involving healthcare professionals, delirium experts, researchers, as well as caregiver and patient representatives. The key intervention component is an 8-point-program, which provides caregivers with recommendations for preventing delirium during the transition phase and in the post-discharge period. Information materials (flyers, handbook, videos, posters, defined "Dos and Don'ts", discharge checklist), training for healthcare professionals, and status analyses are used as implementation strategies. In addition, roles were established for gatekeepers to act as leaders, and champions to serve as knowledge multipliers and trainers for the multi-professional team in the hospitals. CONCLUSIONS: This study serves as an example of how to develop a complex intervention. In an additional step, the intervention and implementation strategies will be investigated for feasibility and acceptability in a pilot study with an accompanying process evaluation. TWEETABLE ABSTRACT: Delirium prevention can benefit from optimizing discharge and transfer processes and involving caregivers of older patients in these procedures. STUDY REGISTRATION: DRKS00017828, German Register of Clinical Studies, date of registration 17.09.2019.

Effectiveness of an individually tailored complex intervention to improve activities and participation in nursing home residents with joint contractures (JointConEval): a multicentre pragmatic cluster-randomised controlled trial.

OBJECTIVE: This study aims to examine the effects of the individually tailored complex intervention Participation Enabling Care in Nursing (PECAN) on activities and participation of residents with joint contractures. DESIGN: Multicentre pragmatic cluster-randomised controlled trial. SETTING: 35 nursing homes in Germany (August 2018-February 2020). PARTICIPANTS: 562 nursing home residents aged ≥65 years with ≥1 major joint contracture (303 intervention group, 259 control group). INTERVENTIONS: Nursing homes were randomised to PECAN (18 clusters) or optimised standard care (17 clusters) with researcher-concealed cluster allocation by facsimile. The intervention targeted impairments in activities and participation. Implementation included training and support for selected staff. Control group clusters received brief information. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint PaArticular Scales combined residents' activities and participation at 12 months. The secondary outcome comprised quality of life. Safety measures were falls, fall-related consequences and physical restraints. Residents, staff and researchers were unblinded. Data collection, data entry and statistical analysis were blinded. Primary analyses were intention-to-treat at cluster level and individual level using a generalised mixed-effect regression model and imputation of missing data. RESULTS: Primary outcome analyses included 301 intervention group residents and 259 control group residents. The mean change on the Activities Scale was -1.47 points (SD 12.2) in the intervention group and 0.196 points (SD 12.5) in the control group and -3.87 points (SD 19.7) vs -3.18 points (SD 20.8) on the Participation Scale. The mean differences of changes between the groups were not statistically significant: Activities Scale: -1.72 (97.5% CI -6.05 to 2.61); Participation Scale: -1.24 (97.5% CI -7.02 to 4.45). We found no significant difference in the secondary outcome and no effects on safety measures. CONCLUSION: The complex intervention did not improve the activities and participation of nursing home residents on the PaArticular Scales at 12 months. Current nursing conditions in Germany may hamper implementation. TRIAL REGISTRATION NUMBER: DRKS00015185.

Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial.

BACKGROUND: Vertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based, multidisciplinary care pathway (CPW) in primary care was developed and pilot tested in a previous study. The aim of the present study is to evaluate the effectiveness and safety of the CPW in terms of improving mobility and participation in community-dwelling older people with VDB in primary care. METHODS: For this multicentre cluster randomised controlled clinic trial, general practitioners (GP) will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. The intervention is an algorithmized CPW. GPs receive a checklist for standardise clinical decision making regarding diagnostic screening and treatment of VDB. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. Implementation strategies comprises educational trainings as well as a workshop to give a platform for exchange for the GPs and PTs, an information meeting and a pocket card for home care nurses and informal caregivers and telephone peer counselling to give all participants the capability, opportunity and the motivation to apply the intervention. In order to ensure an optimised usual care in the control group, GPs get an information meeting addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after 6 month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are physical activity, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate safety and health economic aspects of the intervention. Behavioural changes of the participants as well as barriers, facilitating factors and mechanisms of impact of the implementation will be investigated with a comprehensive process evaluation in a mixed-methods design. DISCUSSION: With our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care. TRIAL REGISTRATION: DRKS, DRKS00028524 retrospectively registered on March 24, 2022.

Challenges and care strategies associated with the admission to nursing homes in Germany: a scoping review.

BACKGROUND: The admission to a nursing home is a critical life-event for affected persons as well as their families. Admission related processes are lacking adequate participation of older people and their families. To improve transitions to nursing homes, context- and country-specific knowledge about the current practice is needed. Hence, our aim was to summarize available evidence on challenges and care strategies associated with the admission to nursing homes in Germany. METHODS: We conducted a scoping review and searched eight major international and German-specific electronic databases for journal articles and grey literature published in German or English language since 1995. Further inclusion criteria were focus on challenges or care strategies in the context of nursing home admissions of older persons and comprehensive and replicable information on methods and results. Posters, only-abstract publications and articles dealing with mixed populations including younger adults were excluded. Challenges and care strategies were identified and analysed by structured content analysis using the TRANSCIT model. RESULTS: Twelve studies of 1,384 records were finally included. Among those, seven were qualitative studies, three quantitative observational studies and two mixed methods studies. As major challenges neglected participation of older people, psychosocial burden among family caregivers, inadequate professional cooperation and a lack of shared decision-making and evidence-based practice were identified. Identified care strategies included strengthening shared decision-making and evidence-based practice, improvement in professional cooperation, introduction of specialized transitional care staff and enabling participation for older people. CONCLUSION: Although the process of nursing home admission is considered challenging and tends to neglect the needs of older people, little research is available for the German health care system. The perspective of the older people seems to be underrepresented, as most of the studies focused on caregivers and health professionals. Reported care strategies addressed important challenges, however, these were not developed and evaluated in a comprehensive and systematic way. Future research is needed to examine perspectives of all the involved groups to gain a comprehensive picture of the needs and challenges. Interventions based on existing care strategies should be systematically developed and evaluated to provide the basis of adequate support for older persons and their informal caregivers.