Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients with Heart Failure: A Pilot Randomized Controlled Trial (Preprint)

BACKGROUND Heart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the US. Clinical and social factors are key drivers of hospitalization. Two strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care utilization in HF. Few studies, if any, have tested a combination of these two strategies in a single intervention. OBJECTIVE To perform a pilot RCT assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled CHW intervention in HF. METHODS Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform + CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department (ED) visits, and missed clinic appointments). RESULTS A total of 56 participants were randomized (N=31 control; N=25 intervention) and 47 participants (N=27 control; N=20 intervention) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78.0% of study days with mean use of 11.4 hours/day (SD 4.6), completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 times/day (SD=0.19), and used the digital weight scale 1 time/day (SD= 0.13). Of intervention participants, 89.5% responded very or somewhat true to the statement “If I have access to the [platform] moving forward, I will use it.” Nine (45%) intervention participants indicated they required support to use the digital platform. Nineteen (90.5%) intervention participants and 25 (92.6%) control participants had ≥5 CHW interactions during the 30 day study period. Most intervention (N=20 [100%]) and control (N=26 [96.2%]) participants who completed trial activities indicated their CHW interactions were “very satisfying.” In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (3 [12%] vs 8 [25.8%]; P= 0.12). Both arms had similar rates of missed clinic appointments and ED visits. CONCLUSIONS This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically-relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes. CLINICALTRIAL ClinicalTrials.gov https://classic.clinicaltrials.gov/ct2/show/NCT05130008 NCT05130008 INTERNATIONAL REGISTERED REPORT RR2-10.2196/55687