Reduction of potentially inappropriate medication in the elderly: design of a cluster-randomised controlled trial in German primary care practices (RIME)

Ulrich Thiem; Stefan Wilm; Wolfgang Greiner; Henrik Rudolf; Hans-Joachim Trampisch; Christiane Müller; Gudrun Theile; Petra A Thürmann

doi:10.1177/2042098620918459

Reduction of potentially inappropriate medication in the elderly: design of a cluster-randomised controlled trial in German primary care practices (RIME)

Ther Adv Drug Saf. 2020 May 12:12:2042098620918459. doi: 10.1177/2042098620918459. eCollection 2020.

Authors

Ulrich Thiem¹, Stefan Wilm², Wolfgang Greiner³, Henrik Rudolf⁴, Hans-Joachim Trampisch¹, Christiane Müller⁵, Gudrun Theile⁶, Petra A Thürmann⁷

Affiliations

¹ Department of Medical Informatics, Biometry and Epidemiology, University of Bochum, Bochum, Germany.
² Institute of General Practice, University of Düsseldorf, Düsseldorf, Germany.
³ Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.
⁴ Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Universitaetsstrasse 150, Bochum, 44801, Germany.
⁵ Department of General Practice, University Medical Centre Goettingen, Germany.
⁶ Klinik Susenberg, Zurich, Switzerland.
⁷ Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.

Abstract

Background: Potentially inappropriate medication (PIM) is considered to have potentially more harmful than beneficial health effects in elderly patients. A German example for a PIM list is the PRISCUS list that has been available since 2010. PIMs are associated with an increased risk of hospitalisation and adverse health outcomes. Furthermore, drug-drug interactions (DDI) may pose additional risks to patients. It is not yet clear how numbers of PIM and DDI can be reduced in community-dwelling seniors in primary care; nor is it clear whether patients would benefit from such deprescribing.

Methods: The cluster-randomised controlled study on the "Reduction of potentially Inappropriate Medication in the Elderly" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI. The intervention consists of professional education and training on the reduction of PIM and DDI, and will be offered to either general practitioners (GPs) alone or GPs and their office staff in the experimental study arm. The control group will be offered professional education and training on more general issues of prescribing in the elderly, not specifically addressing PIM or DDI. The primary endpoint is the difference in the proportion of patients with at least one PIM or DDI between the start of the study and study closure after 12 months as compared between intervention and control group. Secondary endpoints include overall mortality, number of hospitalisations during the course of the study, quality of life and costs. Secondary analyses will be explorative, with the cluster randomisation being factored in.

Discussion: The RIME study will contribute to answering the question of whether an intervention based on the PRISCUS list can reduce the proportion of community-dwelling seniors aged ⩾70 years with at least one PIM and/or DDI, and whether this will result in positive health effects, for example, as regards hospitalisations.

Trial registration: The Study has been registered in the German Clinical Trials Register (DRKS) under the number DRKS00003610.

Keywords: cluster-randomised controlled trial; drug–drug interaction; elderly; medication therapy management; potentially inappropriate medication; primary care.