JMIR Publications

ABSTRACT

Background:

Interventions focused on remote monitoring and social needs care have shown promise in improving clinical outcomes for patients with heart failure (HF). However, patient willingness to use technology as well as concerns about access in under-resourced settings have limited digital platform implementation and adoption. There is little research in HF populations examining the effect of a combined digital and social needs care intervention that could enhance patient engagement in digital platform use while closing gaps in care related to social determinants of health. Here we describe the protocol for a clinical trial of a digitally-enabled community health worker intervention designed for patients with HF.

Objective:

To describe the protocol for a randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of an intervention that combines remote monitoring with a digital platform and community health worker (CHW) social needs care for patients with HF who are transitioning from hospital to home. Given the elevated morbidity and mortality, identifying comprehensive and patient-centered interventions at the time of hospital care transitions that can improve clinical outcomes, impact cost, and augment quality of care for this cohort is a priority.

Methods:

This trial randomized adult inpatient participants (n=50) with a diagnosis of HF receiving care at a single academic healthcare institution to the 30-day intervention (digital platform + CHW pairing + usual care) or the 30-day control (CHW pairing + usual care) arms. All study participants completed baseline questionnaires and 30-day exit interviews and questionnaires. The primary outcomes will be acceptability, feasibility, and preliminary effectiveness.

Results:

This clinical trial opened to enrollment in September 2022 and completed June 2023. Initial results are expected to be published in Spring 2024 and analysis is currently underway. Feasibility outcome measures will include use rates of the biometric sensor (average hours/day), the digital blood pressure monitor (average times/day), the weight scale (average times/ day), and completion of the symptoms questionnaire (average times/day). The acceptability outcome will be measured by the patient response to the truthfulness of the statement that they would be willing to use the digital platform in the future (response options: very true, somewhat true, or not true). Preliminary effectiveness will be measured by tracking 30-day clinical outcomes (hospital readmissions, emergency room visits, and missed PCP and cardiology appointments).

Conclusions:

The results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of supportive home-based social needs care to enhance engagement and potential effectiveness of clinically-focused digital platforms. These results may inform the construction of a future multi-institutional trial designed to test true effectiveness of this intervention in HF. Clinical Trial: This trial is registered through the NIH on clnicaltrials.gov. The ID is: NCT05130008 and the project number is: 1K23HL150287-01. URL: https://clinicaltrials.gov/study/NCT05130008?lat=42.36256789999999&lng=-71.068767&locStr=Massachusetts%20General%20Hospital,%20Fruit%20Street,%20Boston,%20MA&distance=50&term=community%20health%20worker&rank=4#study-overview