Implementing Diabetes Group Visits in Community Health Centers

NCT02347514 | Completed

• 1 other identifier: IRB14-0973
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Community health centers across the US are seeking to address the growing prevalence of diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians' Network (MWCN) to conduct a research study to train community health center staff and providers to implement and sustain diabetes group visits, also referred to as shared medical appointments, at their health center. The study's aims are to: 1) Develop, conduct, and evaluate a training program for health center staff to implement a diabetes group visit intervention in their health center; 2) Assess the implementation of diabetes group visits in the community health center setting and determine the cost of implementation; 3) Assess the feasibility and cost of implementing a text-messaging intervention in addition to the implementation of diabetes group visits in the CHC setting at one health center and 4) Assess the impact of the diabetes group visits alone and diabetes group visits plus text-messaging on diabetes process measures, patient outcomes, and patient satisfaction compared to control patients from the same health center with six months of follow-up once the six-month group visit program ends.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin

  change from baseline to 6 months and 12 months.

Secondary Outcomes (1)

• Summary of Diabetes Self-Care Activities (SDSCA)

  change from baseline to 6 months and 12 months.

Study Arms (2)

Diabetes Group Visit

EXPERIMENTAL

Subjects in this arm will be asked to attend one group visit at their health center each month for six months. The group visits will involve various staff and providers at the health center who will teach them how to take care of their diabetes. Subjects will be scheduled to attend the same group visit appointments as the other subjects, and health center staff will encourage the group to share their own experiences about living with diabetes with the rest of the group. If subjects at the health center additionally implementing the text-messaging intervention consent to enroll in the study, their phone number will also be entered into a secure system that will allow the group visit healthcare team to send them text messages during the course of the six months they are in the program. These text messages are intended to offer the subjects additional support in taking care of their diabetes.

Behavioral: Diabetes group visit

Usual care

NO INTERVENTION

Patients in the control arm will be selected after the follow-up period is over for the intervention arm. They will receive the care they normally receive at their health center.

Interventions

Diabetes group visit BEHAVIORAL

Diabetes Group Visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years of age
• Patients must have been a patient at the health center since the beginning of 2013
• Patients must have attended at least two appointments at the health center within the past year
• Patients must have a diagnosis of type 2 diabetes
• (For group visit patients only) Patients' last documented A1c result must have been greater than or equal to 8.0% and the test must have been done during the last 18 months at the time of the selection
• (For group visit plus text-messaging patients only) Patients must own a cellular phone with text-messaging capabilities
• (For control patients only) Patients must have attended at least three individual appointments at the health center between February 2015 and July 2016.
• (For control patients only) Patients' last documented A1c result prior to the start of the group visit program must have been greater than or equal to 8.0% and the test must have been done during the 18 months prior to the start of the group visit program

You may not qualify if:

• Patients who are under 18 years old, have not been a patient at the health center since the beginning of 2013, have not attended at least two appointments at the health center within the past year, do not have a diagnosis of type 2 diabetes, have not had an A1c test done during the 18 months prior to the start of the group visit program, or whose last documented A1c result before the start of the group visit program was less than 8.0%, will be excluded from the study.
• Pregnant women; patients with an uncontrolled psychiatric problem, such as schizophrenia, psychosis, dementia, or another cognitive impairment; and patients with hearing difficulties or a severe physical disability will also be excluded from the study.
• Patients will also be excluded from participation in the study if their primary care provider deems they would not benefit from participation in a diabetes group visit program and/or does not provide approval for them to be in the study.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 27, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (1)