Clinical trial NCT06094491: Virtual Diabetes Group Visits Across Health Systems
Official title: VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: T2DM (Type 2 Diabetes Mellitus)
Hypertension
Heart Disease Chronic
Stroke
Hyperlipidemias
Peripheral Vascular Diseases
Obesity
Keywords: virtual group visits
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: ACCESS Community Health Network
name: Midwest Clinicians' Network
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-23
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sites
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: A1c
timeFrame: 12 months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 12 months
measure: Low density lipoproteins
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Access Community Health Network
state: Illinois
city: Orland Park
country: United States
facility: Advocate Health Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: Arshiya Baig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zgibor JC, Peyrot M, Ruppert K, Noullet W, Siminerio LM, Peeples M, McWilliams J, Koshinsky J, DeJesus C, Emerson S, Charron-Prochownik D; AADE/UPMC Diabetes Education Outcomes Project. Using the American Association of Diabetes Educators Outcomes System to identify patient behavior change goals and diabetes educator responses. Diabetes Educ. 2007 Sep-Oct;33(5):839-42. doi: 10.1177/0145721707307611.
citation: Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S101-8. doi: 10.2337/dc12-s101. No abstract available.
citation: Iglay K, Hannachi H, Joseph Howie P, Xu J, Li X, Engel SS, Moore LM, Rajpathak S. Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus. Curr Med Res Opin. 2016 Jul;32(7):1243-52. doi: 10.1185/03007995.2016.1168291. Epub 2016 Apr 4.
citation: Li C, Ford ES, Strine TW, Mokdad AH. Prevalence of depression among U.S. adults with diabetes: findings from the 2006 behavioral risk factor surveillance system. Diabetes Care. 2008 Jan;31(1):105-7. doi: 10.2337/dc07-1154. Epub 2007 Oct 12.
citation: Chiou T, Tsugawa Y, Goldman D, Myerson R, Kahn M, Romley JA. Trends in Racial and Ethnic Disparities in Diabetes-Related Complications, 1997-2017. J Gen Intern Med. 2020 Mar;35(3):950-951. doi: 10.1007/s11606-019-05308-9. Epub 2019 Sep 11. No abstract available.
citation: Karter AJ, Ferrara A, Liu JY, Moffet HH, Ackerson LM, Selby JV. Ethnic disparities in diabetic complications in an insured population. JAMA. 2002 May 15;287(19):2519-27. doi: 10.1001/jama.287.19.2519.
citation: Traven SA, Synovec JD, Walton ZJ, Leddy LR, Suleiman LI, Gross CE. Notable Racial and Ethnic Disparities Persist in Lower Extremity Amputations for Critical Limb Ischemia and Infection. J Am Acad Orthop Surg. 2020 Nov 1;28(21):885-892. doi: 10.5435/JAAOS-D-19-00630.
citation: Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003417. doi: 10.1002/14651858.CD003417.pub2.
citation: Watts SA, Strauss GJ, Pascuzzi K, O'Day ME, Young K, Aron DC, Kirsh SR. Shared medical appointments for patients with diabetes: glycemic reduction in high-risk patients. J Am Assoc Nurse Pract. 2015 Aug;27(8):450-6. doi: 10.1002/2327-6924.12200. Epub 2015 Jan 27.
citation: Riley SB, Marshall ES. Group visits in diabetes care: a systematic review. Diabetes Educ. 2010 Nov-Dec;36(6):936-44. doi: 10.1177/0145721710385013. Epub 2010 Oct 25.
citation: Housden L, Wong ST, Dawes M. Effectiveness of group medical visits for improving diabetes care: a systematic review and meta-analysis. CMAJ. 2013 Sep 17;185(13):E635-44. doi: 10.1503/cmaj.130053. Epub 2013 Aug 12.
citation: Edelman D, McDuffie JR, Oddone E, Gierisch JM, Nagi A, Williams JW Jr. Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review [Internet]. Washington (DC): Department of Veterans Affairs (US); 2012 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK99785/
citation: Zulman DM, Verghese A. Virtual Care, Telemedicine Visits, and Real Connection in the Era of COVID-19: Unforeseen Opportunity in the Face of Adversity. JAMA. 2021 Feb 2;325(5):437-438. doi: 10.1001/jama.2020.27304. No abstract available.
citation: Tokuda L, Lorenzo L, Theriault A, Taveira TH, Marquis L, Head H, Edelman D, Kirsh SR, Aron DC, Wu WC. The utilization of video-conference shared medical appointments in rural diabetes care. Int J Med Inform. 2016 Sep;93:34-41. doi: 10.1016/j.ijmedinf.2016.05.007. Epub 2016 Jun 2.
citation: Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.
citation: Barnes PA, Staab EM, Campbell A, Schaefer C, Quinn MT, Baig AA. Organizational Factors Influencing the Early Implementation Process of Diabetes Group Visits by Five Midwestern Community Health Centers: A Multisite Case Study Analysis. Popul Health Manag. 2020 Aug;23(4):297-304. doi: 10.1089/pop.2019.0110. Epub 2019 Nov 6.
citation: Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001 Aug;44(2):119-27. doi: 10.1016/s0738-3991(00)00186-5.
citation: Rose S, Laan MJ. Why match? Investigating matched case-control study designs with causal effect estimation. Int J Biostat. 2009 Jan 6;5(1):Article 1. doi: 10.2202/1557-4679.1127.
citation: Li F, Thomas LE, Li F. Addressing Extreme Propensity Scores via the Overlap Weights. Am J Epidemiol. 2019 Jan 1;188(1):250-257. doi: 10.1093/aje/kwy201.