Integrating Community Health Workers to Improve Diabetes Prevention

NCT ID: NCT03006666

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 773 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2021-05-28

Brief Summary

Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.

Detailed Description

This population based trial aims to understand the impact of peer health interventions on panels of patients in a real clinic environment

Investigators will conduct a cluster-randomized trial to test the impact of peer health coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams to:

1. Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;

2. Promote weight loss among pre-diabetic patients;

3. Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:

1. Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;

2. Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);

3. Improved health behaviors (e.g. making dietary and exercise changes); and

4. Develop, implement and assess strategies to recruit, train, and integrate peer CHW health coaches within the PCMH model.

This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to promote prevention of DM in PCMH practice.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group (Data Only)

The teams randomly allocated to the Control Group will not have access to CHWs.

Group Type: ACTIVE_COMPARATOR

Data Only

Intervention Type: BEHAVIORAL

The teams randomly allocated will not have access to Community Health Workers.

Intervention Group: (CHW Health Coaching Integrated into Team)

Teams randomly allocated to the Intervention Group will also receive regular panel data on their pre-DM patients and will have a CHW join the team, attend team meetings, and provide an outreach intervention to all prediabetic patients in the panel, as described below. CHWs and the researchers will provide regular updates to the team on these activities.

Group Type: EXPERIMENTAL

CHW Training

Intervention Type: BEHAVIORAL

CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.

In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .

The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with "mock" participants (consisting of research staff and advisory board members).

Individuals who do not pass will receive intensive remediation and be required to repeat the examination.

Community Health Worker Coaching Intervention.

Interventions

CHW Training

CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.

In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .

The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with "mock" participants (consisting of research staff and advisory board members).

Individuals who do not pass will receive intensive remediation and be required to repeat the examination.

Community Health Worker Coaching Intervention.

Intervention Type: BEHAVIORAL

Data Only

The teams randomly allocated will not have access to Community Health Workers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years prior to the start date of Phase 2.

Exclusion Criteria

• A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2 years prior to Phase 2
• Treatment with DM medication other than metformin (e.g. insulin or oral agents)
• age greater than 75 years
• exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW outreach.
• Does not speak English or Spanish (necessary to communicate with community health worker)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

New York University Medical Center

New York, New York, United States

Countries

United States

References

Gupta A, Hu J, Huang S, Diaz L, Gore R, Levy N, Bergman M, Tanner M, Sherman SE, Islam N, Schwartz MD. Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices. BMC Public Health. 2023 Mar 28;23(1):575. doi: 10.1186/s12889-023-15477-2.

Reference Type: DERIVED

PMID: 36978071 (View on PubMed)

Islam N, Gepts T, Lief I, Gore R, Levy N, Tanner M, Fang Y, Sherman SE, Schwartz MD. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes. BMC Public Health. 2018 Apr 19;18(1):521. doi: 10.1186/s12889-018-5419-4.

Reference Type: DERIVED

PMID: 29673333 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-00690

Identifier Type: -

Identifier Source: org_study_id