Integrating Community Health Workers to Improve Diabetes Prevention
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|ClinicalTrials.gov Identifier: NCT03006666|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2016
Last Update Posted : July 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: CHW Training Behavioral: Data Only||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||773 participants|
|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 :||July 13, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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.
- Incidence rates of type 2 DM [ Time Frame: 36 Months ]Cumulative DM incidence rates and time to DM incidence
- Weight loss and obesity rates [ Time Frame: 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 [ Time Frame: 36 Months ]The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006666
|United States, New York|
|New York University Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Mark Schwartz, MD||NYU School of Medicine|