Skip to main content
Clinical Trials/NCT05130008
NCT05130008
Completed
Not Applicable

Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure

Massachusetts General Hospital1 site in 1 country56 target enrollmentSeptember 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure,Congestive
Sponsor
Massachusetts General Hospital
Enrollment
56
Locations
1
Primary Endpoint
Intervention Acceptability
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.

Detailed Description

Heart failure (HF) is a highly prevalent disease in the United States, with elevated morbidity and mortality. Nearly 6.2 million people in the US are affected by HF and this number is expected to rise to 8.5 million by 2030. Total direct medical costs of HF, mostly generated by inpatient hospitalizations, are estimated to increase from $21 billion in 2012 to $53 billion by 2030. HF is the leading cause of 30-day readmissions in the US; a quarter of these are considered to be preventable. Most patients with HF are readmitted to hospital medicine services for non-HF co-morbidities (e.g. pneumonia) with clinical, social, and behavioral factors driving readmissions. Despite numerous interventions designed to prevent readmissions, including telemetry monitoring, only marginal HF outcome improvement has been observed. HF readmission rates remain elevated and could be prevented by a multidisciplinary approach promoting better connections to and communication with clinical care teams while addressing social and behavioral barriers to HF care. One approach that has demonstrated improved chronic disease outcomes by addressing social, behavioral, and basic clinical barriers to care- and has yet to be formally studied in HF populations- is community health workers (CHWs). CHWs are members of clinical teams who address social, economic, educational, behavioral, and basic clinical factors influencing health outcomes while fostering patient connections to care teams. CHW care delivery is one of a few interventions shown to reduce readmissions in patients with chronic disease. CHWs have basic clinical knowledge of specific conditions, along with a skillset designed to address social and behavioral drivers of health outcomes like 30-day readmissions. However, CHW care is challenged by key factors, including intensive 1:1 care delivery, limiting its scale and efficiency. In 2016, a biotechnology company launched a HF digital platform within a mobile phone application to help reduce 30-day readmissions in patients with HF by 1) leveraging artificial intelligence to minimize false alarms in biometric monitoring, 2) promoting early identification of decline in HF patients, and 3) encouraging digital and in-person communication between patients and care teams. In preliminary findings, digital platform clinical trial data has shown promise in reducing HF 30-day readmissions. This study will investigate the effectiveness of this platform in combination with CHW care in reducing readmissions for medically and socially complex patients with HF. Through a partnership with the digital platform creators, our team has helped develop a prototype for patients with HF cared for by CHWs ("digitally-enabled" CHW care). Specifically, the aim of this proposal are to assess the acceptability, feasibility, and preliminary effectiveness of implementing a digitally-enabled CHW intervention compared to CHW care to reduce HF 30-day readmissions within a pilot RCT (n=50) My central hypothesis is that pairing patients with a digitally-enabled CHW intervention that addresses social and behavioral barriers to HF care, promotes communication with clinical care teams, and improves CHW efficiency will reduce 30-day readmissions while improving patient engagement with HF care.

Registry
clinicaltrials.gov
Start Date
September 23, 2022
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jocelyn Carter

Physician- Scientist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years
  • HF diagnosis
  • English proficiency
  • Residence within 30 miles of MGH
  • Being cared for by a cardiologist or primary care provider who manages their HF
  • Current use and ownership of a smart phone

Exclusion Criteria

  • Cognitive deficits that prevent digital or human engagement
  • Lack of health insurance
  • Invoked health proxy or guardianship status
  • History of smart phone use

Outcomes

Primary Outcomes

Intervention Acceptability

Time Frame: 30 days

Proportion of patients indicating that they would be willing to use the intervention again

Intervention Feasibility

Time Frame: 30 days

Proportion of patients that used the intervention during the study period

Secondary Outcomes

  • 30-day Readmission Rate(30 days)
  • 30-day Emergency Department Visit Rate(30 days)
  • 30-day Missed Appointment Rate(30 days)
  • Heart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)(Baseline)

Study Sites (1)

Loading locations...

Similar Trials