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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (Data Only) | Active Comparator | The teams randomly allocated to the Control Group will not have access to CHWs. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Schwartz, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36978071 | Derived | 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. | |
| 29673333 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | May 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Data Only | Behavioral | The teams randomly allocated will not have access to Community Health Workers. |
|
| 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. |