BACKGROUND: Overuse is common in frail older people with polypharmacy, especially in frail older users of multidose drug dispensing (MDD) systems.
RESEARCH QUESTION: To investigate the effect of a clinical medication review (CMR) with integration of deprescribing (toolbox) on the number of ceased and dose lowered medications (persistent after 6 months) compared to usual care in older users of MDD systems with hyperpolypharmacy.
HYPOTHESIS: By integrating deprescribing protocols in a CMR for MDD-users (whose medication is often continued without evaluation) in combination with a training for health care providers, deprescribing can be effectively performed and monitored (because of dispensing once every week or 2 weeks), which will lead to a decrease in drug use without increase of health problems.
STUDY DESIGN: Pilot + RCT
STUDY POPULATION: 416 MDD users from 26 community pharmacies = 75 years receiving = 10 chronic drugs
INTERVENTION: a 5-step CMR with a deprescribing toolbox (including deprescribing protocols): 1) patient interview; 2) pharmacotherapeutic analysis; 3) pharmacist and GP discuss actions; 4) actions are discussed with patient; 5) (two)weekly follow-up
OUTCOME MEASURES: Primary: the number of ceased or dose lowered drugs per patient persistent after 6 months. Secondary: PROMs (including health problems with impact on daily life and quality of life); PREMs (patient satisfaction); intermediate outcomes (drug related problems, reasons for restart, number of drugs in use); process outcomes (time consumption health care patient and process related outcomes measures (including adherence to tapering schemes). Qualitative data on feasibility of integration of deprescribing (with toolbox) in CMR. Pharmaco-economic evaluation.
SAMPLE SIZE/DATA-ANALYSIS To detect an effect size of 1 ceased or dose lowered drug: 416 patients. RCT analysis: intention-to-treat and per-protocol; linear mixed model; descriptive analysis of drug related problems and reasons for restart.