"A better system" - managing the adverse effects of prescribed medicines: Cluster-randomised controlled trial and process evaluation of the ADRe Profile in primary care
Abstract
Introduction: The avoidable harm due to incomplete monitoring of repeat prescriptions in primary care has been known for decades, but prevention has proved difficult. We aimed to test the ability of the Adverse Drug Reaction (ADRe) Profile to identify and address clinical problems for patients aged ≥65 prescribed >4 long-term medicines, living in their own homes, and managed in primary care.
Methods: A pragmatic cluster-randomized controlled trial was undertaken in 6 primary care practices in South-West Wales, alongside a process evaluation. In addition to usual care, patients in the intervention arm completed the ADRe Profile, which was then shared with the practice pharmacist. Patients completed a second ADRe Profile with the nurse researcher 20 weeks later. The control arm received usual care. Information on patients' clinical problems and prescriptions was extracted from practice medical records before and after the intervention and analysed using multilevel generalised linear mixed models (GLMM), including practice as a random intercept, and accounting for trial arm, age, deprivation and co-morbidities. Symptoms recorded on the first and second Profiles were compared. Resolution of clinical problems was described, and participants' perspectives sought.
Results: We recruited one general practice group, comprising six practices, and 60 patients. Three patients were lost to the study. Intervention arm patients were more likely to have more than one problem addressed than…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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