Disparities in cardiovascular disease can occur when disadvantaged low-income patients with a serious illness such as heart failure are unable to reap the benefit of life-saving drugs and, as a consequence, experience repeat hospitalizations which are costly in dollars and quality of life. We have observed, in a prior trial, that 53% of low-income patients with heart failure were not receiving evidencebased therapy from their doctors and 37% were not taking at least 80% of the pills they were prescribed. To improve both patient and doctor adherence, and reduce costly repeated hospitalizations, the aim is to conduct a multi-level behavioral randomized efficacy trial that simultaneously intervenes on both doctors and the patients. The primary outcome is all-cause hospitalization days over a 2.5-year follow-up. Using a cluster randomization scheme, the doctors of 320 patients who have income <$30,000 and are hospitalized with acute decompensated heart failure at 3 recruiting hospitals will be randomized to a chronic care treatment or enhanced education control. In the education control, patients will receive standard heart failure education in the form of 12 Tip Sheets from the American Heart Association, and doctors will receive the 2009 ACC/AHA guidelines for the management of heart failure. In the chronic care treatment, both patients and doctors will receive the same information as received in the control. But, in addition, patients will receive training in self-management skills provided by a culturally competent community health worker using an ethnographically-designed heart failure management kit Doctors will receive online and in-person training in the management of patients with heart failure in exchange for continuing education credit. Effectiveness of the intervention will be evaluated not only by the primary endpoint but also by secondary endpoints that include patient adherence to drugs from electronic pill caps, patient adherence to salt restriction from a food frequency questionnaire, doctor adherence to guidelines from electronic medical records, and quality of life. Results will determine whether culturally sensitive approaches to low-income patients and their doctors can reduce hospitalizations over that observed using standard health education and guidelines alone.
Hospitalizations with any mention of heart failure have tripled over the past 25 years and low-income patients are differentially affected. This trial aims to reduce repeat hospitalizations in low-income patients with heart failure by providing a culturally sensitive intervention for both patients and doctors. If successful, this treatment could save tremendous costs, in dollars and life quality, associated with heart failure.
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