Diabetes Management Intervention For South Asians

Study Overview
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Brief Summary
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The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.

Official Title
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Diabetes Management Intervention For South Asians

Conditions
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HbA1c, Diabetes

Intervention / Treatment
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* Behavioral: Community Health Worker (CHW)-led health
* Behavioral: HIT-enabled
* Behavioral: Physician enabled care coordination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: South Asian ethnicity (identified through a race and language code available in the EHR); an appointment with a physician for routine non-emergent primary care in the last 12 months a diagnosis of diabetes for at least 12 months an HbA1c reading of >7 in the last 30 days Exclusion Criteria: Pregnant women and visits to obstetrician/gynecologist are excluded from the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHW-led health coaching<br>Group sessions | Behavioral: Community Health Worker (CHW)-led health<br>* Patients contacted a maximum of 10 times over 2 weeks to attend diabetes management sessions led by community health workers. Enrolled patients attend 5 Monthly group sessions led by a CHW held at the clinic<br>|
| Experimental: HIT-enabled & CHW led<br>Supportive care enabled by mobile devices. | Behavioral: HIT-enabled<br>* During one on one visit, CHWs will assess social needs of patients using mobile technology. CHWs will give referral sources to patients generated by mobile app, and they will track through mobile app.<br>|
| Experimental: CHW & Physician Feedback<br>Patient setting progress communicated to physician via PHI | Behavioral: Community Health Worker (CHW)-led health<br>* Patients contacted a maximum of 10 times over 2 weeks to attend diabetes management sessions led by community health workers. Enrolled patients attend 5 Monthly group sessions led by a CHW held at the clinic<br>Behavioral: Physician enabled care coordination<br>* Forms on patient goal setting and referrals made are uploaded into EHR to physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients that experience a reduction in HbA1c of >0.5% | complete lipoprotein panel compared at baseline and 6 months | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average reduction in hemoglobin A1c test (HbA1c) | complete blood panel compared at baseline and 6 months | 6 Months | 
| Average reduction in BMI (Body Mass Index) | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. | 6 Months | 
| Average reduction HDL (High density lipoprotein cholesterol) | complete lipoprotein panel compared at baseline and 6 months | 6 Months | 
| Average reduction LDL (Low density lipoprotein cholesterol) | complete lipoprotein panel compared at baseline and 6 months | 6 Months | 
| Referral to community services | Number of referrals given to community service over the course of 6 months | 6 Months |