Integrating Community Health Workers to Improve Diabetes Prevention

Diabetes Mellitus Clinical Trial

Official title:

Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006666
• Other study ID #: 16-00690
• Status: Completed
• Phase: N/A
• Start date: July 13, 2017
• Est. completion date: May 28, 2021

Study information

• Verified date: June 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 773
• Est. completion date: May 28, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• 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.
• Data Only
The teams randomly allocated will not have access to Community Health Workers.

Locations

Country	Name	City	State
United States	New York University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates of type 2 DM	Cumulative DM incidence rates and time to DM incidence	36 Months
Primary	Weight loss and obesity rates	Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.	36 Months
Primary	Patient Activation Measure (PAM) scores	The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.	36 Months