Clinical trial NCT03006666: Integrating Community Health Workers to Improve Diabetes Prevention
Official title: Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 773
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Incidence rates of type 2 DM
timeFrame: 36 Months
measure: Weight loss and obesity rates
timeFrame: 36 Months
measure: Patient Activation Measure (PAM) scores
timeFrame: 36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Mark Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.