VIDA: Virtual Diabetes Group Visits Across Health Systems

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06094491

Collaborator

Advocate Health Care (Other), ACCESS Community Health Network (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH), Midwest Clinicians' Network (Other)

720

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).

Condition or Disease	Intervention/Treatment	Phase
T2DM (Type 2 Diabetes Mellitus) Hypertension Heart Disease Chronic Stroke Hyperlipidemias Peripheral Vascular Diseases Obesity	Behavioral: Virtual Group Visit	N/A

Detailed Description

Managing diabetes can be complex and burdensome; patients must modify their diet, take medications, check their blood sugar, and visit their healthcare providers regularly. Diabetes group visits (GVs)-virtual group education and diabetes support, including goal setting-create a unique setting where patients can connect with peers and receive medical care and support. GVs can improve glycemic control and decrease healthcare utilization. GVs can provide patients with comprehensive care for their multimorbid chronic condition.

Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites. Before the model can be widely adopted, important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed. The investigators propose to build on an established program of diabetes GVs. This proposal aims to implement the virtual GV model (VIDA: Virtual Diabetes Group Visits Across Health Systems) in two distinct health systems in the Chicago region. Access Community Health Network (ACCESS) is one of the largest federally qualified health centers (FQHCs) in the United States with 35 sites across the Chicago metropolitan area, providing care for 175,000 medically underserved and low-income patients each year, including over 25,000 patients with diabetes and 30,000 patients who are uninsured; 60% of ACCESS' patients are Hispanic and 30% are African-American. Advocate Health Care (ADVOCATE) is a large, diverse, integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites. The system provides care across more than 129 primary care clinics in Illinois serving over 117,000 patients, of which 27% identify as African American/Black and 15% identify as Hispanic/Latino. Both are community-based health systems serving low-income and communities of color in Chicago and are network partners of the Chicago Chronic Condition Equity Network (C3EN).

No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems. The ability to train, implement, and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the barriers and facilitators for implementation. This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

720 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Type I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sitesType I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sites

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Group Visit Arm These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.	Behavioral: Virtual Group Visit Group visits must have these core components: diabetes education, group social support and goal setting.
No Intervention: Usual Care Arm These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

Arm

Intervention/Treatment

Experimental: Virtual Group Visit Arm

These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.

Behavioral: Virtual Group Visit

Group visits must have these core components: diabetes education, group social support and goal setting.

No Intervention: Usual Care Arm

These subjects will receive usual diabetes care at ACCESS or Advocate health centers.

Outcome Measures

Primary Outcome Measures

A1c [12 months]
This is blood test that measures the percent of glucose and hemoglobin bound together.

Secondary Outcome Measures

Systolic blood pressure [12 months]
Systolic blood pressure measures the arterial pressure
Body Mass Index [12 months]
Measure of body fat based on height and weight
Low density lipoproteins [12 months]
a measure of cholesterol in the blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient at a participating clinic (at least one visit in year prior to first GV)
Type 2 diabetes
≥ 18 years old
A1C>8% within 6 months prior to first GV (we will first recruit patients with A1C>9%, then if spaces still available A1C>8.5%, then if spaces still available A1C>8%)
At least one additional cardiovascular condition (hypertension, heart disease, stroke, hyperlipidemia, peripheral vascular disease, or BMI ≥ 30)
English or Spanish speaking
PCP assented to recruiting patient
Patient provides written consent