An interventional study of Diabetes MESSAGES Program and Diabetes MESSAGES Program (second trial) in Type 2 Diabetes Mellitus, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of Chicago · Not applicable, Interventional, and Health services research
Diabetes group visits, shared appointments where patients receive self-management education in a group setting and have a medical visit, are a promising way to deliver high quality diabetes care. Group visits can improve glycemic control and decrease healthcare utilization. To date, no studies have systematically implemented a diabetes group visit intervention in a network of U.S. community health centers. The University of Chicago is partnering with Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten Midwestern states. Approximately half of all Federally Qualified Health Centers in this region are affiliated with MWCN. The objectives of the study are [1] providers and staff at 20 health centers will have the requisite knowledge, skills, and motivation to implement a diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical outcomes; and health care utilization for patients participating in the diabetes group visit program will be evaluated; and [3] the diabetes group visit program will be available for dissemination among and use by health centers and healthcare providers at the local, state, regional, and national levels.
UChicago and MWCN will recruit and enroll 20 health centers (HCs) to participate in a training intervention and to implement diabetes group visit and text messaging programs at their clinic sites. Each HC will assemble a team of 3-4 providers and staff to participate in the training. HCs will be randomized to one of two training cohorts. HC providers and staff will attend two in-person Learning Sessions in Chicago and a series of monthly webinars, recruit and enroll patients, implement a 6-month diabetes group visit and text messaging program plus subsequent booster sessions, complete periodic surveys and interviews, assist with data collection through patient surveys and chart abstraction, and present their program to peer HCs during Learning Sessions and to local stakeholders, state primary care organizations, or other professional groups. Each HC will enroll 15 patients in the group visit and text messaging program; the 2018 Training Cohort will do so immediately following their enrollment in the study and the 2020 Training Cohort will do so after 18 months. During the first 18 months, the 2020 Training Cohort will collect data from electronic health records (EHR) of randomly selected patients to serve as a control group. Changes in self-reported outcomes, diabetes processes of care, and clinical outcomes will be assessed for intervention patients from baseline through 2 year follow up, and processes of care and clinical outcomes will be compared for intervention vs. control participants. Capacity of HC providers and staff to conduct a group visit and text messaging intervention for patients with diabetes, as well as their confidence in identifying and addressing health disparities, will be evaluated through surveys and in-depth interviews. This study will expand knowledge of the barriers, facilitators, and perceived benefits and drawbacks of group visit and text messaging interventions and inform the development of a toolkit that will be disseminated to other HCs.
Exclusion Criteria:
10 health centers will be randomized to the 2018 Training Cohort. Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).
Other: Diabetes MESSAGES Program
10 health centers will be randomized to the 2020 Training Cohort. Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group. After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).
Other: Diabetes MESSAGES Program (second trial)
Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care. After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
Hemoglobin A1C
Time frame: change from baseline to 12 months
Hemoglobin A1C
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Blood pressure
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Weight
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Cholesterol
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Diabetes processes of care
Receipt of recommended screenings, exams, referrals, and vaccinations
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Medication management of diabetes
changes in prescribed diabetes medications for patients with inadequate diabetes control
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Number of hypoglycemic events
Time frame: baseline, 6 month, and 12 month for intervention patients only
Number of hospital admissions
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Number of primary care, specialist, and ER visits
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Smoking status
Time frame: baseline, 6 month, and 12 month for intervention patients only
Health related quality of life (SF-12)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Depression (PHQ-2)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Summary of Diabetes Self-Care Activities Measure
Time frame: baseline, 6 month, and 12 month for intervention patients only
Understanding of Diabetes Self-Management (Diabetes Care Profile)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Attitudes Towards Diabetes (Diabetes Care Profile)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Distress Scale (DDS-2)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Quality of Life Scale
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Self-Empowerment Scale
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Social Support Scale
Time frame: baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with intervention
Time frame: 6 month and 12 month for intervention patients only
CAHPS Overall Rating
Patient satisfaction with overall care at health center
Time frame: baseline, 6 month, and 12 month for intervention patients only
CAHPS Cultural Competency
Patient satisfaction with cultural competency of care at health center
Time frame: baseline, 6 month, and 12 month for intervention patients only
CAHPS Provider Communication
Patient satisfaction with provider communication at health center
Time frame: baseline, 6 month, and 12 month for intervention patients only
Patient engagement
Attendance/participation in group visits, text messaging, and booster sessions
Time frame: through study completion, an average of 2 years
Health center provider/staff preparedness
Capacity, confidence, motivation, perceived benefits and barriers
Time frame: change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
Health center provider/staff satisfaction
Satisfaction with training, group visits, and text messaging
Time frame: post-training (16 month)
Plan to share: No
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