Improving medication adherence using family-focused and literacy-sensitive strategies in patients with heart failure - Project Summary Medication adherence is thought by many providers and researchers to be the most important self-care behavior, yet it is also the most problematic. Poor medication adherence can cause poor quality of life (QoL), hospitalization, and death. In the United States, approximately 125,000 deaths per year are due to poor medication adherence and up to 50% of heart failure (HF) patients are re-hospitalized within 6 months of a previous HF exacerbation and one of the most common causes is poor medication adherence. Lifelong and usually complex medication regimens are needed for patients with HF, yet 40-60% of HF patients have suboptimal medication adherence. Health literacy plays a significant role in suboptimal medication adherence. Support by a care partner (CP; usually a family member) can improve adherence and reduce hospitalizations. Although some interventions have improved HF patients’ adherence, improvements were small, and effects were not sustained. To enhance and sustain intervention effects, we will use an approach that is literacy- sensitive and incorporates social support. Using easy-to-understand language for patients and CPs, we will test an interactive, behavioral, family-focused and literacy-sensitive (FamLit) intervention delivered by nurses, incorporating evidence-based, multi-components (e.g., teach-back, coaching, role-playing, goal setting) to engage both patients and CPs in improving and sustaining medication adherence and health outcomes. We will conduct a randomized controlled trial to evaluate the efficacy of FamLit intervention on medication adherence, hospitalization, death, and QoL. We will randomly assign 164 dyads of patients and their primary CPs (patients-CPs) to either the FamLit intervention or an attention-control group. Both groups will have an in- person session (delivered on the day of a clinic appointment for regular follow-up) one month after baseline and phone boosters every other week for up to 3 months. FamLit group sessions will focus on improving medication adherence, and control group sessions will focus on general health issues. Our aims are to: 1) test the efficacy of the FamLit intervention compared to an attention control group on outcomes (i.e., primary: medication adherence, and secondary: a) HF hospitalization or all-cause death, b) QoL, c) social support, and d) communication) over 12 months; 2) determine if TPB-related intermediate outcomes (attitudes, subjective norms, perceived behavioral control) mediate the effects of the intervention on medication adherence; 3) examine whether each dyad member’s a) health literacy, b) social support, and c) communication moderate the effect of the FamLit intervention on medication adherence; and 4) determine how each dyad member’s attitudes, subjective norms, perceived behavioral control, social support, and communication affect their own and their partner’s QoL over 12 months using the innovative Actor-Partner Interdependence Model. The FamLit intervention, if efficacious, holds potential to improve/sustain medication adherence and reduce hospitalizations and death. We will follow up with an effectiveness-implementation hybrid trial as our next step.
