Establishing a telemedical supported trans-sectoral collaboration network from community support to emergency care for outpatient care recipients: study protocol of a prospective non-randomized complex intervention study with a pragmatic approach, Stay@Home – Treat@Home
Authors: Müller Doreen , Jachan Deborah Elisabeth , Stahl Maria , Rosenbusch Marie-Luise , Liersch-Mazan Daniela , Lippert Peggi , Hinricher Niels , Ivanova Maria ,   STH Research Group, Schulz Mandy , Lahmann Nils 
Published: December 2024

Abstract
Background
Demographic changes in Germany are increasing the number of outpatient care recipients, who often resort to emergency care due to difficulties accessing timely outpatient medical care. Previous studies suggest that early detection and telemedical interventions could reduce unnecessary hospitalizations. The new form of healthcare aims to provide continuous, flexible healthcare for outpatient care recipients using digital technologies to detect health deteriorations and facilitate interventions at home. The goal of our study is to evaluate, whether the number of emergency situations and hospital stays will be reduced, and health outcomes will be improved compared to standard care.

Methods
In this prospective non-randomized complex intervention study with a pragmatic approach, we aim to evaluate a new form of healthcare focused on establishing an interdisciplinary network for outpatient care in the homes of care-dependent individuals. Utilizing a digital interactive health diary, health data will be gathered from participants, caregivers, and healthcare providers, covering both stable primary care and acute situations. A telemedical network will coordinate measures, including non-medical aid, nursing care, and medical assistance. A total of 1,500 participants will be recruited for the intervention group, matched with a control group from health insurance data. A second control group with n=300 will provide self-reported measures. The study is planned to span eight quarters, with data collected from the digital interactive health diary and health insurance records. Evaluation perspectives include health insurance, patients, and healthcare providers, assessing utilization and costs compared to standard care, health status, health-related quality of life, care dependency, interdisciplinary cooperation, and usability of the new technology.

Discussion
Demographic change results in a larger older people population, exacerbating mobility issues and care dependency, worsened by the shortage of medical personnel. Stay@Home – Treat@Home aims to enable home health monitoring and care, reducing hospitalizations. The digital interactive health diary supports direct communication, allows remote monitoring, and empowers patients and caregivers to manage health changes. Nursing aid personnel and physicians can access entries for informed interventions. The development of the digital interactive health diary aims to improve the situation of care-dependent individuals. Evaluating its effectiveness and efficiency is crucial for the development and implementation of new technologies.

Trial registration
German Clinical Trials Register, ID: DRKS00034260, registered on May 14, 2024 (retrospectively registered): https://drks.de/search/de/trial/DRKS00034260 and https://who.int/clinical-trials-registry-platform/network/who-data-set.