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Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization (MEDICATION)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00903032
First received: May 13, 2009
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Condition Intervention
Acute Coronary Syndrome
 Behavioral: Intervention
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Patient-Centered Adherence Intervention After ACS Hospitalization

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Adherence to cardioprotective medications (clopidogrel, statins, beta blockers, ACE-inhibitor/ARB) [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: July 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
 Behavioral: Intervention
The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Active Comparator: Arm 2
Patients will receive usual care following ACS hospital discharge
 Behavioral: Usual care
Usual care following ACS hospital discharge.

Detailed Description:

RATIONALE: Acute coronary syndrome, including acute myocardial infarction (MI) is one of the leading causes of hospitalization for veterans. Recent advances in the treatment of acute MI have led to declines in hospital mortality. Despite this, the risk of recurrent events and mortality after the index MI hospitalization remains substantial in the following year. Non-adherence to proven cardioprotective medications is a potentially modifiable risk factor that contributes to the persistently high risk of adverse outcomes following MI hospitalization. Prior interventions to improve medication adherence in cardiovascular populations have produced mixed results and have not specifically targeted patients after acute coronary syndrome (ACS) hospital discharge. It is currently unknown if interventions targeting medication non-adherence in the year after ACS discharge will improve medication adherence and intermediate outcomes or will be cost-effective

OBJECTIVE(S): We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and LDL-cholesterol goals, reduces cardiac endpoints (MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

METHODS: We propose a 3-year, multi-site patient-level randomized controlled trial to evaluate, relative to usual care, a multi-faceted patient-centered intervention to improve adherence to cardioprotective medication among veterans following ACS hospital discharge. The study will enroll 280 patients to intervention versus usual care for 12-months at 3 VA Medical Centers (Eastern Colorado, Puget Sound, and Central Arkansas). The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and tele-monitoring. The primary analyses will be a comparison of adherence to cardioprotective medications using pharmacy refill records based on the ReCOMP adherence measure developed in the VA. Secondary analyses will compare achievement of secondary prevention BP and LDL goals and cardiac events. In addition, cost-effectiveness analysis will be performed. All analyses will be intention to treat

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients admitted with acute coronary syndrome (ACS) as the primary reason for hospital admission and use the VA for their usual source of care, defined as having 1 primary care visit within the 12 months prior to hospital admission will be screened for eligibility to participate. ACS is defined as acute myocardial infarction (both ST-elevation MI and non-ST elevation MI) or unstable angina. The presence of acute myocardial infarction will be defined using standard definitions from an international consensus statement, based on the following: a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following:

  1. symptoms of ischemia;
  2. ECG change indicative of new ischemia (new ST-T changes or new left bundle branch block);
  3. development of pathological Q waves in the ECG; or
  4. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.42 Unstable angina will be defined by presence of ischemic symptoms and ECG changes indicative of new ischemia but without biomarker evidence of myonecrosis (i.e., biomarker elevation) and no evidence of new pathological Q waves, loss of viable myocardium or regional wall motion abnormality.

Exclusion Criteria:

  1. Patient admitted for primary non-cardiac diagnosis and develop ACS as a secondary condition (e.g. perioperative MI);
  2. planned discharge to nursing home or skilled nursing facility;
  3. irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
  4. lack of telephone/cell phone;
  5. VA is not primary source of care;
  6. regularly fill medications at non-VA pharmacy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903032

Locations
United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Michael Ho, MD PhD VA Eastern Colorado Health Care System, Denver
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00903032     History of Changes
Other Study ID Numbers: IIR 08-302
Study First Received: May 13, 2009
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
compliance/adherence

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013