Effects of care of multimorbid patients in general practices by Advanced Practice Nurses (FAMOUS): Study Protocol for a non-randomized controlled trial

Background: Multimorbidity is a common phenomenon in patients treated in general practices. Key challenges of this group are functional difficulties, polypharmacy, treatment burden, fragmentation of care, reduced quality of life and increased healthcare utilisation. These problems cannot be solved in the short consultation time of a general practitioner (GP) since there is an increasing shortage of GPs. In many countries Advanced Practice Nurses (APNs) are successfully integrated into primary health care for multimorbid patients. The objective of this study is to examine whether the implementation of APNs in the primary care of multimorbid patients in Germany leads to an optimized care of the target group and to a reduction in the workload of the GPs. Methods APNs care for multimorbid patients in general practice for twelve months; this is the intervention. Qualifications for APNs include a master's level academic degree and 500 hours of project-specific training. Their tasks are: in-depth assessment, preparation, implementation, monitoring and evaluation of a person-centred and evidence-based care plan. In the design of a non-randomized controlled trial, a prospective multi-centre mixed methods study is conducted. Main inclusion criterion is: three chronic diseases. For data collection of the intervention group (n= 817), routine data from health insurance companies and Statutory Health Insurance Physicians (ASHIP) are used, as well as day-to-day documentation of the care process, standardized questionnaires and qualitative interviews. In addition, the intervention will be assessed in a longitudinal design. The control group (n= 1634) will receive standard care. For the evaluation routine data from health insurance companies are matched 1:2. Outcomes are measured using emergency contacts and GP visits, treatment costs, health status of the patients and satisfaction of parties involved. The statistical analyses use Poisson regression to compare outcomes between intervention and control groups. Descriptive and analytical statistical methods are used in the longitudinal analysis of the intervention group data. Cost analysis will compare total costs and subgroup costs between the intervention and control groups. Qualitative data will be analysed using content analysis. Discussion A challenge could be the political and strategic environment as well as the planned number of participants. Trial registration DRKS00026172 on DRKS