Integrating Community Health Workers to Improve Diabetes Prevention

NYU Langone Health

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: CHW Training; Behavioral: Data Only

Study type: Interventional

Funder types: Other

Identifiers

NCT03006666

16-00690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 773 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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773 participants in 2 patient groups

Control Group (Data Only)

Active Comparator group

Description:

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

Treatment:

Behavioral: Data Only

Intervention Group: (CHW Health Coaching Integrated into Team)

Experimental group

Description:

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.

Treatment:

Behavioral: CHW Training