Reduction of care-relevant risks to older patients during and after acute hospital care (ReduRisk) – study protocol of a cluster randomized efficacy trial in a stepped wedge design

BACKGROUND: Older patients are at an increased risk of hospitalization, negatively affecting their health and quality of life. Such patients also experience a lack of physical activity during their inpatient stay, as well as being at increased risk of delirium and inappropriate prescribing. These risk factors can accumulate, promoting a degree of morbidity and the development of cognitive impairment. METHODS: Through the ReduRisk-program, patients at risk of functional impairment, immobility, falls, delirium or re-hospitalization shortly after hospital discharge, will be identified via risk-screening. These patients will receive an individually tailored, multicomponent and risk-adjusted prevention program. The trial will compare the effectiveness of the ReduRisk-program against usual care in a stepped-wedge-design, with quarterly cluster randomization of six university hospital departments into intervention and control groups. 612 older adults aged 70 years or more are being recruited. Patients in the intervention cluster (n = 357) will receive the ReduRisk-program, comprising risk-adjusted delirium management, structured mobility training and digitally supported planning of post-inpatient care, including polypharmacy management. This study will evaluate the impact of the ReduRisk-program on the primary outcomes of activities of daily living and mobility, and the secondary outcomes of delirium, cognition, falls, grip strength, health-related quality of life, potentially inappropriate prescribing, health care costs and re-hospitalizations. Assessments will be conducted at inpatient admission (t0), at discharge (t1) and at six months post-discharge (t2). In the six-month period following discharge, a health-economic evaluation will be carried out based on routine health insurance data (t3). DISCUSSION: Despite the importance of multicomponent, risk-specific approaches to managing older patients, guidelines on their effectiveness are lacking. This trial will seek to provide evidence for the effectiveness of a multicomponent, risk-adjusted prevention program for older patients at risk of functional impairment, immobility, falls, delirium and re-hospitalization. Positive study results would support efforts to improve multicomponent prevention and the management of older patients. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00025594, date of registration: 09/08/2021.