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

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.

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial

“…Unlike other similar studies, the group was not preselected according to medication, disease, or age group [23,24]. As a result, the focus of GP training was on dealing with polypharmacy in general, and did not attempt to provide in-depth instruction on how to optimize specific cases, as is the case in polypharmacy trials with narrower inclusion criteria [25,26]. Moreover, some of the included patients did not profit from the intervention because there were very few or sometimes even no alerts that could be reacted to.…”

Anticholinergic burden measures, symptoms, and fall-associated risk in older adults with polypharmacy: Development and validation of a prognostic model

“…For this study, variables on ACh symptoms, a history of falls, and cognitive function were additionally taken from the studies. The RIME study (Reduction of potentially Inadequate Medication in the Elderly [ 33 , 34 ]) and the PRIMUM study (PRIoritizing Multimedication in Multimorbidity [ 35 ]) were the only two cRCTs from PROPERmed to include this data and were therefore considered in this analysis. Both trials aimed to optimize medication in older German general practice (GP) patients.…”

Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model

“…To avoid systematically missing variables, only trials that are able to provide the set of additional variables will be considered for our study. Therefore, we will only consider data from the two trials RIME ( Thiem et al, 2020 ) and PRIMUM ( Muth et al, 2018 ) for model development. Both cRCTs were conducted in German general practices and aimed to optimize medication in older chronically ill patients from this setting.…”