Methods: This pilot randomized control trial will enroll 40 heart failure patients from a large public hospital. Inclusion criteria requires participants be adults (18 or older), speak English or Spanish, and be diagnosed with Class II or Class III heart failure with an ejection fraction of 45% or lower. Participants in the control condition will receive usual care. Participants in the Meds to Beds condition will receive medications delivered bedside at the hospital prior to discharge. Patient records will be monitored for 60 days after discharge, with a telephone follow-up approximately 30 days after discharge.
Data analysis. Differences between conditions in main outcomes (medication adherence and health) will be tested using mixed ANOVA. Adherence will be assessed with pharmacy records and the self-report Adherence to Refills and Medications Scale (Kripalani, Risser, Gatti, & Jacobson, 2009). Self-reported physical health will be evaluated with the PROMIS 10-item scale (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Hospital readmissions and deaths will be evaluated with medical records using a chi-square test. In addition, a self-report measure developed for this study will assess the five adherence factors described by the World Health Organization as mechanisms of action of adherence among participants. Feasibility and acceptability of Meds to Beds will be assessed with successful medication delivery and a self-report measure, respectively.
Results: Data collection is presently underway and expected to be completed Spring 2019.
Conclusion: By providing participants medication during the critical period after hospital discharge (Oosterom-Calo, et al., 2013), this intervention addresses all five adherence barriers as recommended by the World Health Organization (2003). Results will indicate whether the Meds to Beds intervention has promising effects on outcomes compared to usual care. Specifically, results will show if patients possess prescribed medication before they leave the hospital, they may reduce non-adherence, improve health and reduce hospital readmissions by overcoming adherence barriers. Thus, if Meds to Beds is feasible and satisfactory to patients, the intervention could be implemented and tested on a larger scale in other hospital settings.