Medication Adherence Intervention for Myocardial Ischemia and Rheumatic Diseases
(SEPPRMACI-ARM Trial)
Trial Summary
What is the purpose of this trial?
Ischemic heart disease (IHD) and its treatment carry profound public health and economic implications. Among Veterans, IHD represents one of the most common causes of death and disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far less common than IHD can affect multiple organ systems and requires therapies costing in excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease requires a number of medications to maintain or improve health. Not taking medications as prescribed, however, is common and increases the risk of subsequent adverse events (cardiac death and myocardial infarction \[MI\]). To improve medication adherence rates and the cardiac health of Veterans with IHD, the investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM (Secondary Event Prevention using Population Risk Management After PCI and for Anti-Rheumatic Medications), this intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals if they have not refilled their medication a given number of days after it was due for refill. The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients not completing SMS and then IVR by not refilling their medication (or declining SMS and not completing IVR) escalate to a trained research interventionalist. The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient. The investigators will test the intervention on IHD patients who have recently undergone PCI-a cardiac procedure commonly used among IHD patients to improve the heart's blood flow and in patients starting anti-rheumatic medication. The investigators will test the intervention at four VA Cardiac Catheterization Laboratories (CCLs) and have 12 sites serving as usual care controls.
Research Team
Liron Caplan, MD PhD
Principal Investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
Eligibility Criteria
This trial is for Veterans with ischemic heart disease who've had a PCI or are starting anti-rheumatic medication. They must be taking specific meds, get care from the VA, and have a VA-assigned primary care provider. It's not for those only diagnosed via catheterization, prisoners, pregnant women, terminally ill patients, those using non-VA medicine sources or in nursing facilities, or individuals with impaired decision-making.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive a multi-faceted patient-centered intervention to improve medication adherence, including SMS, IVR, and contact with a trained interventionalist.
Follow-up
Participants are monitored for cardiovascular events and medication adherence effectiveness after the intervention.
Cost Effectiveness Analysis
Establish the cost to implement and maintain the intervention and assess incremental cost effectiveness.
Treatment Details
Interventions
- Caplan IVR
- VA SEPPRMACI-ARM
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Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor