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

NCT02694185 | Completed Results DMC

• 3 other identifiers: IIR 14-04816-14191I01HX001604-01A2
• Study Type: interventional
• Target: 5,269
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Myocardial Ischemia; Rheumatic Diseases

Keywords

Medication Adherence; Randomized Controlled Trial; Veterans

Outcome Measures

Primary Outcomes (1)

• Proportion of Days Covered (PDC)

  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.

  1 year

Secondary Outcomes (2)

• Cardiovascular Events (CVE)

  1 year

• Incremental Cost Effectiveness (ICE)

  through study completion, an average of 1 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

This group will undergo the intervention as described in the protocol

Other: Caplan IVR

Control Group

NO INTERVENTION

This group will not receive the intervention, they will receive usual care

Interventions

Caplan IVR OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (5)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

VA Caribbean Healthcare System, San Juan, PR

San Juan, 00921, Puerto Rico

Location

Related Publications (7)

• Raghavan S, Liu WG, Michael Ho P, Plomondon ME, Baron AE, Caplan L, Joynt Maddox KE, Magid D, Saxon DR, Voils CI, Bradley SM, Maddox TM. Coronary artery disease severity modifies associations between glycemic control and both mortality and myocardial infarction. J Diabetes Complications. 2018 May;32(5):480-487. doi: 10.1016/j.jdiacomp.2018.01.010. Epub 2018 Jan 31.

  PMID: 29483016 BACKGROUND

• Baker JF, Sauer B, Teng CC, George M, Cannon GW, Ibrahim S, Cannella A, England BR, Michaud K, Caplan L, Davis LA, O'Dell J, Mikuls TR. Initiation of Disease-Modifying Therapies in Rheumatoid Arthritis Is Associated With Changes in Blood Pressure. J Clin Rheumatol. 2018 Jun;24(4):203-209. doi: 10.1097/RHU.0000000000000736.

  PMID: 29664818 BACKGROUND

• Yazdany J, Caplan L, Fitzgerald J, Schmajuk G. Editorial: The Evolving Art and Science of American College of Rheumatology Guidelines. Arthritis Rheumatol. 2019 Jan;71(1):2-4. doi: 10.1002/art.40725. Epub 2018 Nov 30. No abstract available.

  PMID: 30499229 BACKGROUND

• McCulley CB, Barton JL, Cannon GW, Sauer BC, Teng CC, George MD, Caplan L, England BR, Mikuls TR, Baker JF. Body mass index and persistence of conventional DMARDs and TNF inhibitors in rheumatoid arthritis. Clin Exp Rheumatol. 2019 May-Jun;37(3):422-428. Epub 2018 Nov 7.

  PMID: 30418120 BACKGROUND

• Hirsh J, Wood P, Keniston A, Boyle D, Quinzanos I, Caplan L, Davis L. Universal Health Literacy Precautions Are Associated With a Significant Increase in Medication Adherence in Vulnerable Rheumatology Patients. ACR Open Rheumatol. 2020 Feb;2(2):110-118. doi: 10.1002/acr2.11108. Epub 2020 Jan 19.

  PMID: 31957348 BACKGROUND

• Raghavan S, Liu WG, Berkowitz SA, Baron AE, Plomondon ME, Maddox TM, Reusch JEB, Ho PM, Caplan L. Association of Glycemic Control Trajectory with Short-Term Mortality in Diabetes Patients with High Cardiovascular Risk: a Joint Latent Class Modeling Study. J Gen Intern Med. 2020 Aug;35(8):2266-2273. doi: 10.1007/s11606-020-05848-5. Epub 2020 Apr 24.

  PMID: 32333313 BACKGROUND

• Daniel CM, Davila L, Makris UE, Mayo H, Caplan L, Davis L, Solow EB. Ethnic Disparities in Atherosclerotic Cardiovascular Disease Incidence and Prevalence Among Rheumatoid Arthritis Patients in the United States: a Systematic Review. ACR Open Rheumatol. 2020 Sep;2(9):525-532. doi: 10.1002/acr2.11170. Epub 2020 Sep 1.

  PMID: 32869533 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Rheumatic Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Elizabeth Cheng
• Organization: Rocky Mountain Regional VA Medical Center

elizabeth.cheng@va.gov

720-857-5101

Study Officials

• Liron Caplan, MD PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 29, 2016
• Study Start: October 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2025
• Last Updated: May 27, 2026
• Results First Posted: June 25, 2021

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (4)