Cross-sectoral gerontopsychiatric treatment and rehabilitation in nursing homes (SGB Reha)—study protocol for a stepped-wedge cluster randomized trial
Abstract
Background Demographic changes in Germany have increased the need for care to 5.7 million people, with around 800,000 living in residential care facilities. Nursing home residents are vulnerable, suffering from multimorbidity and cognitive impairments, with prevalent use of psychotropic medication linked to negative outcomes like sedation and hospitalizations. So far, there is little research on multimodal rehabilitation programs in nursing homes. The SGB Reha study aims to implement a cross-sectoral rehabilitation model to improve activities of daily living (ADLs), cognition, and quality of life for nursing home residents, reducing hospitalizations and treatment costs, and increasing the chance of residents returning home post-care. Methods The study is conducted in 12 nursing homes located in North Rhine-Westphalia and Hamburg. It employs a cluster-randomized stepped-wedge design with randomization at the facility level. Data collection occurs at three consecutive measurement points, at 0, 3, and 6 months. The recruitment target includes 720 nursing home residents across four six-month study phases. Nursing home residents aged 65 years and older who had been admitted to the nursing home within the previous 12 months—either as a routine admission or following a hospital stay—and who have a care level of at least 2 are eligible for inclusion. The intervention integrates therapeutic and rehabilitative nursing practices. Structured multidisciplinary case conferences (including neurologists/psychiatrists, and consulting pharmacists) establish objectives, assess progress, adapt personalized care, develop therapeutic strategies, and systematically evaluate medications, especially emphasizing the reduction of psychotropic drugs and polypharmacy prevention. A multidisciplinary team delivers the intervention, supported by study nurses coordinating processes. In addition to resident outcomes, the study evaluates quality of life among relatives and job satisfaction among nursing home staff, allowing assessment of intervention effects across multiple stakeholder groups. Discussion The intervention aims to enhance ADLs, cognition, and quality of life for nursing home residents. By combining effectiveness, health-economic, qualitative, and process evaluations, the study adopts a health services perspective that extends beyond resident-level outcomes to include relatives, staff, organizational processes, and healthcare system implications. Results of the trial are intended to contribute to the further development of rehabilitation-oriented and gerontopsychiatric care structures in German nursing homes. From an economic perspective, we anticipate a reduction in treatment costs. This can contribute to a sustainable cross-sectoral care model that integrates therapeutic-rehabilitative approaches into standard care in residential long-term care. Trial status Recruitment and data collection are complete; analyses are ongoing (protocol reported after conclusion of data collection). Clinical Trial Registration https://www.isrctn.com/ISRCTN11686133, ISRCTN Registry, identifier ISRCTN11686133.