Integrating Community Health Workers to Improve Diabetes Prevention

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03006666

Collaborator

(none)

773

Enrollment

Location

Arms

46.5

Actual Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: CHW Training Behavioral: Data Only	N/A

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:

Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
Promote weight loss among pre-diabetic patients;
Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
Improved health behaviors (e.g. making dietary and exercise changes); and
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

773 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 13, 2017

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group (Data Only) The teams randomly allocated to the Control Group will not have access to CHWs.	Behavioral: Data Only The teams randomly allocated will not have access to Community Health Workers.
Experimental: 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.	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.

Arm

Intervention/Treatment

Active Comparator: Control Group (Data Only)

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

Behavioral: Data Only

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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Mark Schwartz, MD, NYU School of Medicine

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Mar 21, 2019

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03006666

Other Study ID Numbers:

16-00690

First Posted:

Dec 30, 2016

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Jun 7, 2022