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Trial record 9 of 17 for:    cardiac catheterization | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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 : Recruiting
First Posted : February 29, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Myocardial Ischemia Rheumatic Diseases Other: Caplan IVR Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 participants
Allocation: Randomized
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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cardiovascular Events (CVE) [ Time Frame: 1 year ]
    Cardiovascular Events (CVEs) such as myocardial infarction, and 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will qualify for inclusion if they:

  • Undergo PCI or are prescribed a DMARD
  • Are prescribed any of the following medications:

    • A statin
    • Beta-blocker
    • Thienopyridines (IHD intervention) and hydroxychloroquine
    • Oral methotrexate
    • Sulfasalazine
    • Azathioprine
    • Leflunomide
    • Tofacitinib (rheumatic disease intervention)

      • [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).

Exclusion Criteria:

Patients will be excluded under the following circumstances:

  • Undergoing only diagnostic catheterization
  • Receive their index medicines (listed in item 2 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

Information from the National Library of Medicine

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


Contacts
Contact: Robert Klocko, MA (720) 857-5101 robert.klocko@va.gov
Contact: Liron Caplan, MD PhD (720) 857-5103 liron.caplan@va.gov

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Jeffrey Zimmet, MD    415-221-2692 ext 2692    jeffrey.zimmet@va.gov   
Contact: Shirley Chao, PharmD    4152212468    shirley.chao@va.gov   
United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Recruiting
Aurora, Colorado, United States, 80045
Contact: Robert Klocko, MA    720-857-5101    robert.klocko@va.gov   
Contact: Liron Caplan, MD PhD    (720) 857-5103    liron.caplan@va.gov   
Principal Investigator: Liron Caplan, MD PhD         
Sub-Investigator: P. Michael Ho, MD PhD         
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Frank Cintineo, PharmD    410-605-7000 ext 3552    frank.cintineo@va.gov   
Contact: , PharmD         
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Sunil Rao, MD    919-286-0411 ext 6942    sunil.rao@va.gov   
Contact: Jennifer Taylor, PharmD    9192860411 ext 5649    jennifer.taylor7@va.gov   
Puerto Rico
VA Caribbean Healthcare System, San Juan, PR Recruiting
San Juan, Puerto Rico, 00921
Contact: Orlando Rodriguez-Vila, MD    787-641-7582 ext 11785    orlando.rodriguez-vila@va.gov   
Contact: , PharmD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Liron Caplan, MD PhD Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02694185     History of Changes
Other Study ID Numbers: IIR 14-048
16-1419 ( Other Identifier: CIRB )
1 I01 HX001604-01A2 ( Other Identifier: Denver VAMC )
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Medication Adherence
Randomized Controlled Trial
Veterans

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Coronary Disease
Ischemia
Myocardial Ischemia
Rheumatic Diseases
Collagen Diseases
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Musculoskeletal Diseases
Connective Tissue Diseases