Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications
Completed · Not applicable
Conditions studied: Myocardial Ischemia, Rheumatic Diseases
In brief
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.
Key facts
- Study ID
- NCT02694185
- Run by
- VA Office of Research and Development
- People needed
- 5269
- Starts
- 2016-10-01
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients will qualify for inclusion if they:
- Undergo PCI or are prescribed a DMARD.
- Are prescribed any of the following medications:
- [for the IHD intervention]
- Statin
- Beta-blocker
- Thienopyridines (dual platelet inhibitors)
- [for the DMARD intervention]
- Oral methotrexate
- Sulfasalazine
- Azathioprine
- Leflunomide
- Tofacitinib
- Hydroxychloroquine [Note: as a study focused on adherence, the investigators will NOT address the appropriateness of prescribed medications, which is an important, but separate issue]
- Receive their care from the VA. This is defined by the presence of a VA-assigned-PCP in the year prior to PCI or in the year following PCI (IHD intervention) or in the year prior to or following index DMARD prescription (rheumatic disease intervention).
You may not qualify if…
- Patients will be excluded under the following circumstances:
- Undergoing only diagnostic (non-interventional) catheterization
- Receive their index medicines (listed in item above) from a non-VA source
- Discharge to nursing home or skilled nursing facility
- Individuals with impaired decision making capacity
- Prisoners
- Pregnant women
- The terminally ill
Where it is running
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
- VA Caribbean Healthcare System, San Juan, PR — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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