Integrating Community Health Workers to Improve Diabetes Prevention

NCT03006666 | Completed

• 1 other identifier: 16-00690
• Study Type: interventional
• Target: 773
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Incidence rates of type 2 DM

  Cumulative DM incidence rates and time to DM incidence

  36 Months

• 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

• Patient Activation Measure (PAM) scores

  The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.

  36 Months

Study Arms (2)

Control Group (Data Only)

ACTIVE COMPARATOR

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

Behavioral: Data Only

Intervention Group: (CHW Health Coaching Integrated into Team)

EXPERIMENTAL

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

Interventions

CHW Training 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.

Intervention Group: (CHW Health Coaching Integrated into Team)

Data Only BEHAVIORAL

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

Control Group (Data Only)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Does not speak English or Spanish (necessary to communicate with community health worker)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 36978071 DERIVED

• 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.

  PMID: 29673333 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mark Schwartz, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: July 13, 2017
• Primary Completion: May 1, 2021
• Study Completion: May 28, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

US (1)