NCT02694185: SEPPRMACI-ARM

Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications

Active, enrolled NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Caplan IVR in Myocardial Ischemia in 5,269 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2016

Primary endpoint
31 December 2019

28 February 2025

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	5,269
Start date	1 October 2016
Primary completion	31 December 2019
Estimated completion	28 February 2025
Sites	5 locations across Puerto Rico, United States

Drugs / interventions tested

• Caplan IVR

Conditions studied

• Myocardial Ischemia — all drugs for Myocardial Ischemia →
• Rheumatic Diseases — all drugs for Rheumatic Diseases →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 95, any sex, with Myocardial Ischemia or Rheumatic Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Days Covered (PDC) Primary · 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.

Anti-platelet

Group	Value	95% CI
Experimental Group	82.6	77.9 – 86.2
Control Group	75.6	69.7 – 79.9

Beta-Blocker

Group	Value	95% CI
Experimental Group	78.4	71.5 – 82.7
Control Group	73.3	66.8 – 77.1

Statin

Group	Value	95% CI
Experimental Group	78.8	71.8 – 83.4
Control Group	71.2	64.9 – 75.1

Cardiovascular Events (CVE) Secondary · 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.

Group	Value	95% CI
Experimental Group	15.2	10.9 – 25.5
Control Group	14.3	12.3 – 16.7

Incremental Cost Effectiveness (ICE) Secondary · 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.

Group	Value	95% CI
Experimental Group	821.45	158.18 – 1541.91
Control Group	893.55	437.85 – 1460.85

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.