Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications (SEPPRMACI-ARM)
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|ClinicalTrials.gov Identifier: NCT02694185|
Recruitment Status : Active, not recruiting
First Posted : February 29, 2016
Results First Posted : June 25, 2021
Last Update Posted : October 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia Rheumatic Diseases||Other: Caplan IVR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5269 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Secondary Event Prevention Using Population Risk Management After PCI|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Experimental Group
This group will undergo the intervention as described in the protocol
Other: Caplan IVR
This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). 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 failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). 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.
No Intervention: Control Group
This group will not receive the intervention, they will receive usual care
- Proportion of Days Covered (PDC) [ Time Frame: 1 year ]Proportion of Days Covered (PDC) is measured by looking at the number of doses of medication a patient has versus days in the month (if a patient has 20 days of medication for a 30 day period their PDC is 20/30, 2/3, or 66.7%). Used to assess the effectiveness of the intervention, PDC will be tested among IHD patients in the year after PCI and among rheumatology clinic patients chronically prescribed DMARDs.
- Cardiovascular Events (CVE) [ Time Frame: 1 year ]Cardiovascular Events (CVEs) such as mortality, myocardial infarction, stroke, or repeat revascularization among IHD patients at 12 months post-PCI and progressive erosive disease demonstrated in patients with rheumatic disease will be monitored. CVEs will be monitored to determine if there is a reduction in the occurrence of those events as a result of the intervention.
- Incremental Cost Effectiveness (ICE) [ Time Frame: through study completion, an average of 1 year ]To establish the cost to implement and maintain the intervention, above the cost of usual care. Incremental Cost Effectiveness (ICE) is the cost to achieve a 10% improvement in PDC, and the cost of CVE prevented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694185
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA|
|San Francisco, California, United States, 94121|
|United States, Colorado|
|Rocky Mountain Regional VA Medical Center, Aurora, CO|
|Aurora, Colorado, United States, 80045|
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|VA Caribbean Healthcare System, San Juan, PR|
|San Juan, Puerto Rico, 00921|
|Principal Investigator:||Liron Caplan, MD PhD||Rocky Mountain Regional VA Medical Center, Aurora, CO|