Fellowship/Jia-Rong Wu: Effect of a Medication Taking Behavior Feedback, Theory-Based Intervention on Outcomes in Patients with Heart Failure

BACKGROUND: Nonadherence to heart failure (HF) medications contributes to rehospitalization and mortality, yet there are few successful interventions that enhance adherence in HF and nonadherence remains a major factor driving rehospitalization. Current educational approaches have not been theory driven, a problem that has contributed to lack of successful interventions. We propose a test of an intervention based on the Theory of Planned Behavior (TPB) that includes providing feedback of objectively measured medication-taking behavior using the Medication Event Monitoring System (MEMS) to enhance their medication adherence. OBJECTIVE: The purpose of this study is to determine whether an education and counseling intervention based on the IFS in which feedback of personal medication-taking behavior using the MEMS is provided to HF patients will improve outcomes (i.e., HF hospitalization, mortality and quality of life) by enhancing adherence. METHODS: A randomized controlled trial of 123 nonadherent HF patients will be conducted. Prior to randomization, adherence of all eligible patients who agree to participate will be measured using the MEMS during a baseline 1-month period. Patients who are nonadherent (i.e., C 89% adherence, the level we identified as predictive of better outcomes in our prior research, based on the number of days the correct number of doses taken in one month) will be randomly assigned to one of three groups: 1) theory-based education and counseling plus MEMS feedback (PLUS group); 2) theory-based education and counseling only (LITE group); or 3) a usual 6are control group. Patients who are adherent (i.e., at least 89% adherence) will not be randomized and their participaton in the study ended Patients assigned to either of the two intervention groups (PLUS or LITE) will receive individualized teaching and counseling over 2 months MEMS data will be used to provide feedback to patients in the PLUS group only. Data regarding rehospitalizations and mortality will be determined by medical record review, hospital administrative records, and patient/family interview. Patients will be followed for 6 months after the end of the intervention. Repeated measures ANOVA and Cox proportional hazards models will be used to determine the effect of the intervention Results of this study may provide health care providers with an effective intervention to better educate patients and improve medication adherence and health outcomes.