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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00903032 |
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: | Health Services Research, Randomized, Open Label, Parallel Assignment |
| Official Title: | Patient-Centered Adherence Intervention After ACS Hospitalization |
| Estimated Enrollment: | 280 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
The multifaceted 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 telemonitoring via IVR technology as well as patient-specific aides based on identified needs.
|
Behavioral: Intervention
The multifaceted 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 telemonitoring via IVR technology as well as patient-specific aides based on identified needs.
|
|
2: Active Comparator
Patients will receive usual care following ACS hospital discharge
|
Behavioral: Usual care
Usual care following ACS hospital discharge.
|
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 |
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:
Exclusion Criteria:
Patient admitted for primary non-cardiac diagnosis and develop ACS as a secondary condition (e.g.
perioperative MI);
Contacts and Locations| Contact: Anne C Lambert-Kerzner, BS MSPH | (303) 370-7596 | anne.lambert-kerzner@va.gov |
| Contact: Michael Ho, MD PhD | (303) 370-7579 | michael.ho@va.gov |
| United States, Colorado | |
| VA Eastern Colorado Health Care System, Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, Washington | |
| VA Puget Sound Health Care System, Seattle | |
| Seattle, Washington, United States, 98108 | |
| Principal Investigator: | Michael Ho, MD PhD | VA Eastern Colorado Health Care System, Denver |
More Information
| Responsible Party: | Department of Veterans Affairs ( Ho, Michael - Principal Investigator ) |
| Study ID Numbers: | IIR 08-302 |
| Study First Received: | May 13, 2009 |
| Last Updated: | May 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00903032 History of Changes |
| Health Authority: | United States: Federal Government |
|
compliance/adherence |
|
Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases Ischemia |
|
Heart Diseases Pathologic Processes Disease Myocardial Ischemia |
Syndrome Acute Coronary Syndrome Vascular Diseases Cardiovascular Diseases |
