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

Heart Failure,Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130008
• Other study ID #: 2018P002014
• Secondary ID: 1K23HL150287-01
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: August 15, 2024

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: Jocelyn A Carter, MD
• Phone: 617-726-4801
• Email: jcarter0[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 15, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

Other:
• Digitally-enabled CHW Care
Patients will be paired with a CHW and be encouraged to wear the arm biosensor continuously, take blood pressure daily, respond to short symptom assessments daily or every other day, complete weekly life quality surveys, watch weekly HF educational videos and engage in digital (e.g., video visit) and phone-based, and in-person CHW interactions. Each participant will have access to the digital platform and CHW staff during their hospitalization and for the 30 days following discharge for a typical study duration of approximately 32-35 days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Behavioral:
• Usual CHW Care
Patients will be paired with a CHW for 30-days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Abdel-All M, Putica B, Praveen D, Abimbola S, Joshi R. Effectiveness of community health worker training programmes for cardiovascular disease management in low-income and middle-income countries: a systematic review. BMJ Open. 2017 Nov 3;7(11):e015529. doi: 10.1136/bmjopen-2016-015529. — View Citation

Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24. — View Citation

McHugh MD, Ma C. Hospital nursing and 30-day readmissions among Medicare patients with heart failure, acute myocardial infarction, and pneumonia. Med Care. 2013 Jan;51(1):52-9. doi: 10.1097/MLR.0b013e3182763284. — View Citation

Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	Proportion of patients per a internally validated satisfaction scale that were very or somewhat satisfied with intervention use	12 months
Other	Medication Compliance	Proportion of patients demonstrating improved medication compliance on the MMAS after the intervention	12 months
Other	Quality of Life (patient perceptions and attitudes, functionality and mobility)	Proportion of patients demonstrating improved perceived quality of life on the KCCQ after the intervention	12 months
Primary	Intervention Acceptability	Proportion of patients indicating that they would be willing to use the intervention again	12 months
Primary	Intervention Feasibility	Proportion of patients that used the intervention during the study period	12 months
Primary	Heart Failure Knowledge	Proportion of patients with improved perceived heart failure knowledge ( per an internally validated knowledge questionnaire) after the intervention	12 months
Secondary	30-day readmission rate	Proportion of patients readmitted to the hospital within 30-days after hospital discharge	12 months
Secondary	30-day missed appointment rate	Proportion of patients missing PCP or specialty appointments within 30-days after hospital discharge	12 months
Secondary	30-day Emergency Department visit rate	Proportion of patients returning to the Emergency Department within 30-days of hospital discharge	12 months