Clinical trial NCT03487692: Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes
Official title: Diabetes MESSAGES (Medical Care, Education, Social Support, And Goal-setting to Empower Self-management): Implementing Diabetes Group Visits and Text Messaging in Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
group visit
shared medical appointment
text messaging
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Midwest Clinicians' Network
name: CareMessage
First posted: 2018-04-04
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* diagnosis of type 2 diabetes
* attended at least two appointments at the HC within the past year, with at least one of them being during the past six months
* last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months)
* own a cellular phone with text messaging capabilities
* have the ability to read and send text messages
* English or Spanish speaking

Exclusion Criteria:

* pregnant or planning to become pregnant
* uncontrolled psychiatric problem
* dementia or other cognitive impairment
* hearing difficulties or severe physical disability that would prevent them from participation in group visit
* planning to relocate in the next year or leave the area during the group visit period

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: change from baseline to 12 months
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Blood pressure
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Weight
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Cholesterol
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Diabetes processes of care
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Medication management of diabetes
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Number of hypoglycemic events
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Number of hospital admissions
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Number of primary care, specialist, and ER visits
timeFrame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
measure: Smoking status
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Health related quality of life (SF-12)
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Depression (PHQ-2)
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Summary of Diabetes Self-Care Activities Measure
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Understanding of Diabetes Self-Management (Diabetes Care Profile)
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Attitudes Towards Diabetes (Diabetes Care Profile)
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Diabetes Distress Scale (DDS-2)
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Diabetes Quality of Life Scale
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Diabetes Self-Empowerment Scale
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Diabetes Social Support Scale
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: Patient satisfaction with intervention
timeFrame: 6 month and 12 month for intervention patients only
measure: CAHPS Overall Rating
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: CAHPS Cultural Competency
timeFrame: baseline, 6 month, and 12 month for intervention patients only
measure: CAHPS Provider Communication
timeFrame: baseline, 6 month, and 12 month for intervention patients only
Other outcomes:
measure: Patient engagement
timeFrame: through study completion, an average of 2 years
measure: Health center provider/staff preparedness
timeFrame: change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
measure: Health center provider/staff satisfaction
timeFrame: post-training (16 month)
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Arshiya Baig, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: