DREAMeR: Drug use Reconsidered in the Elderly using goal Attainment scales during Medication Review; Study protocol of a randomised controlled trial

Abstract

Background: Clinical medication reviews (CMR) are increasingly performed in older patients with polypharmacy. Studies have shown positive effects of CMR on process- and intermediate outcomes, like drug-related problems (DRPs). Little effect has been shown on clinical outcomes, like hospital admissions or health-related quality of life (HR-QoL). In particular, HR-QoL is related to the individual health-related goals and complaints of patients. The aim of this study is to investigate the effects of a CMR focused on personal goals on HR-QoL and health-related complaints in older patients with polypharmacy. Methods: A randomised controlled trial will be performed in 35 Dutch community pharmacies aiming to include 630 patients aged 70 years and older using seven or more chronic drugs. Patients will be randomly assigned to control or intervention group by block-randomisation per pharmacy. Patients in the intervention group receive a CMR focused on patients' preferences, personal goals and health-related complaints. With every goal a goal attainment scale (GAS) will be proposed. Primary outcome measures are HR-QoL, measured with the EQ-5D-5L and EQ-VAS and the number of health-related complaints per patient measured with a written questionnaire, during a follow-up period of six months. Secondary outcomes are healthcare utilisation, number and type of drug changes, number and type of health-related goals, scores on GAS and number and type of DRPs and interventions. Discussion: This study is expected to add evidence on the effects of a CMR on HR-QoL and health-related complaints in older patients with polypharmacy. New in this study is the use of personal goals measured with GAS and health-related complaints as patient-related outcome measures. Trial registration: Netherlands Trial Register; NTR5713.