Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled…

Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial

Trials, January 2015

25572800

Alan J Forster, Tobias E Erlanger, Alison Jennings, Claudine Auger, David Buckeridge, Carl van Walraven, Robyn Tamblyn

Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events (ADEs). Since these issues may be interconnected, efforts to improve non-adherence should also include reduction of ADEs. We have developed the ISTOP-ADE system (Information Systems-enabled Outreach for Preventing Adverse Drug Events), which enables timely monitoring and managing of ADEs. The objectives of this study are to determine whether the ISTOP-ADE system, compared to routine care, will reduce: a) the probability of discontinuing the use of prognosis-altering medications; b) the probability of a patient experiencing a severe ADE; c) the proportion of patients experiencing ADEs, preventable ADEs and ameliorable ADEs; and d) health services utilization.Methods/design: We will randomly assign 2,200 adult ambulatory patients in the province of Quebec who have been prescribed an incident medication for the management or prevention of a chronic health condition, to routine care or the ISTOP-ADE system. The ISTOP-ADE system consists of an interactive voice response system (IVRS) paired with pharmacist support. The IVRS will call patients at 3 and 17 days post-prescription to determine if they are experiencing any problems and connect them with a pharmacist when required or desired by the patient. We will evaluate medication persistence at 180 days and health-care utilization using provincial administrative data. Two blinded physicians will ascertain ADE status through a case review.