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

BACKGROUND: 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 Québec 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. DISCUSSION: We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence, reduced ADE duration and reduced number of ADEs resulting in an emergency department or inpatient encounter. This in turn could lower health-care utilization, saving costs and lowering the burden on emergency departments and family practices. The success of ISTOP-ADE would present opportunities to implement this intervention through health systems, health insurance agents and commercial pharmacies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02059044. Date registered: 10 January 2014.