Medication Reviews Bridging Healthcare (MedBridge): Study protocol for a pragmatic cluster-randomised crossover trial

Abstract

Background: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.

Aim: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.

Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.

Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.

Participants: Patients aged 65years or older, admitted to one of the study wards.

Exclusion criteria: Palliative stage; residing in other than the hospital's county; medication review within the last 30days; one-day admission.

Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care.

Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up period.

Data collection and analyses: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using hierarchical models.

Relevance: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.

Keywords: Cluster analysis; Crossover design; Inappropriate prescribing; Integrated health care systems; Medication review; Pragmatic clinical trial.