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N/A N=253 Randomized Health Services Research

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

Acute Coronary Syndrome

Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) — 89.3; 73.9 percentage of participants — p=0.003

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Intervention (Behavioral); Usual care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
US Department of Veterans Affairs
Primary completion
Mar 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)
89.3; 73.9 0.003 sig

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 (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.

Eligibility 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:

  • 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 Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00903032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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