Comparative Effectiveness of Diabetes Shared Medical Appointment Models

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Behavioral: Patient-driven SMA
Behavioral: Standardized SMA

Registration Number: NCT03590041

Lead Sponsor: University of Colorado, Denver

Brief Summary: In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.

Detailed Description: Type II Diabetes is a prevalent chronic disease with poor outcomes, and requires daily self-care, including blood glucose monitoring, following a diabetes-friendly diet, engaging in regular physical activity, and medication adherence. Patients with diabetes benefit from comprehensive diabetes self-management education (DSME) and self-management support (SMS) in primary care. Shared medical appointments (SMAs) are one way to efficiently and effectively provide DSME and SMS. SMAs can have a variety of different features, but it is not known which features are most effective for which types of patients. Patients and other stakeholders engaged in planning this study proposed a model with "diabetes' veterans" (i.e., diabetes peer mentors) who co-facilitating group visits with a variety of diabetes care professionals, and then working one-on-one with patients to help apply what they learned. The group visit curriculum should include topics on physical activity, healthy eating, taking medication, acceptance and coping, and social support, and each cohort of patients should get to select topics most relevant to them. The practice stakeholders want to do more comprehensive group visit models, but need to know the extent to which SMA participation and patient-centered outcomes are improved compared to the more common standardized approaches they tend to use now.

In this study, the investigators will compare the effectiveness of patient-driven diabetes SMAs to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator. For the patient-driven SMAs, patients choose the topics and the order of sessions from the TTIM curriculum, which is delivered collaboratively by the multidisciplinary care team consisting of several professional providers (health educator, medical provider, and behavioral health provider) and a lay worker (diabetes peer mentor). The primary patient-centered outcome, selected by patient stakeholders, is diabetes distress. Secondary outcomes include autonomy support and diabetes self-management behaviors, clinical outcomes (hemoglobin A1c, blood pressure, and body mass index), patient reach and engagement, and practice-level value and sustainability. Patient, caregiver, practice, health plans, and research stakeholders will be engaged in all aspects of the research. Patients and other stakeholders will inform the process of implementation of patient-driven and standardized SMAs, help finalize the research protocol (including data collection and recruitment), and contribute to interpretation of findings and dissemination of findings, including messages that help other patients make decisions about whether or not to participate in SMAs.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1085

Inclusion Criteria

Patients must be:
1. at least 18 years old,
2. have Type II Diabetes, and
3. receive care in a participating practice.
For a practice to be eligible, they must be;
1. a Federally Qualified Health Center,
2. a private primary care practice, or
3. Community Mental Health Center with primary care,
4. They need to have
  1. a current panel of at least 150 adult patients with Type 2 Diabetes, and
  2. access to health educators, Behavioral Health Professionals, and diabetes peer mentors.

Exclusion Criteria

Are currently pregnant or plan to become pregnant in the next six months,
Have limited cognitive ability due to dementia or a developmental disorder,
Less than one year of life expectancy, or
Plan to leave the area in the next year.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-driven SMA	Patient-driven SMA	In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic.
Standardized SMA	Standardized SMA	The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices.

Primary Outcome Measures

Name	Time	Method
Diabetes Distress - Change in Patient Reported Outcomes (PROs)	At end of 6 group visits (time differs by practice, up to 6 months)	Comparison of change in patient-reported outcomes around diabetes distress for patients in either SMA group. Measured by the Diabetes Distress Scale (DDS-17). The DDS-17 measures the worries, concerns and fears among individuals with diabetes over time as they struggle with managing diabetes. The DDS is a 17-item self-report instrument. Each of the 17 items is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." The scale yields an overall distress score based on the average responses for all items. Average score of \< 2.0 = reflects little or no distress Average score between 2.0 and 2.9 = reflects moderate distress Average score \> 3.0 = reflects high distress A total score \> 2.0 (moderate distress) is considered clinically significant

Secondary Outcome Measures

Name	Time	Method
Change in Patient HbA1c	At end of 6 group visits (time differs by practice, up to 6 months)	Comparison of change in patient HbA1c levels for patients in either SMA group. Measured by Electronic Medical Record data. It evaluates the average amount of glucose in the blood by measuring the percentage of glycated (glycosylated) hemoglobin