Status:
COMPLETED
Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 (prima...
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 de...
Eligibility Criteria
Inclusion
- 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:
- symptoms of ischemia;
- ECG change indicative of new ischemia (new ST-T changes or new left bundle branch block);
- development of pathological Q waves in the ECG; or
- 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
- Patient admitted for primary non-cardiac diagnosis and develop ACS as a secondary condition (e.g. perioperative MI);
- planned discharge to nursing home or skilled nursing facility;
- irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
- lack of telephone/cell phone;
- VA is not primary source of care;
- regularly fill medications at non-VA pharmacy.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00903032
Start Date
July 1 2010
End Date
August 1 2013
Last Update
April 27 2015
Active Locations (4)
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1
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
2
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
3
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
4
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108