DESCRIPTION (provided by applicant): Challenge area Comparative Effectiveness Research (05), Topic Prevention of Chronic Diseases in Disparity Populations, 05-MD-102. Although the development of new therapeutic modalities against CVD has reduced overall CVD mortality by nearly 50%, the gap between certain minority groups and non-minority groups has not diminished. There is preliminary evidence, including our own, that after coronary stent placement subjects that belong to minority populations are less adherent to antiplatelet therapy (clopidogrel) and are more likely to have cvd outcomes. The focus of the proposed study is to examine a non-traditional care- management approach delivered by a large commercial health benefit carrier in the prevention of CVD secondary outcomes among disparity populations who have undergone coronary artery stenting (PCI). In particular, we seek to determine if a culturally tailored phone based Motivational Interviewing (MINT) intervention delivered to African American (AA) and Latino patients is effective at improving adherence to clopidogrel, a medically proven intervention that dramatically reduces stent thrombosis, myocardial infarction and death, and that is standard of care for at least 12 months after stent placement according to ACC/AHA guidelines. We propose a two step screening process that involves access to real time claims data and phone calls to identify Humana subjects post PCI that belong to an ethnic minority. We will then randomize 500 subjects (50% AA and 50% Latinos) to either MINT intervention sessions (four to seven) delivered by trained nurses or a behavior reinforcement DVD in the language of the participant's preference that provides the type of detailed empathetic counseling that should be given at the time of stent placement. Recruitment will last 6 months and follow up 12 months. We will be able to detect a 15% difference between the groups in the proportion of subjects that have clopidogrel available 80% or more of the therapy time (12 months) based on refilling patterns captured by claims data and by self report. We hypothesize that MINT will increase the proportion of subjects adequately adherent to clopidogrel from 55% (in preliminary data) to over 70%. Additionally we will evaluate causes of non adherence to this important medication among AA and Latinos. . Ethnic minorities still face significant cardiovascular diseases disparities including worst outcomes after stent placement. We propose a RCT of 500 privately insured minority subjects to compare the effectiveness of a culturally tailored phone based motivational interviewing intervention to a counseling DVD in the language of preference at improving clopidorel adherence after Percutaneous Coronary Intervention with stent placement. We will also explore reasons for clopidogrel non adherence in this population found to be as high as 50% in our preliminary data.
|Effective start/end date||9/20/09 → 6/30/12|
- National Institutes of Health: $449,294.00
- National Institutes of Health: $498,034.00
Comparative Effectiveness Research
Percutaneous Coronary Intervention
Standard of Care
- Social Sciences(all)