Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

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.
    

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, Pudget 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
    

Intervention name(s): Intervention; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Usual care following ACS hospital discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: compliance/adherence