Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus Type 2, Comparative Effectiveness Trial
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.
Interventions
BEHAVIORALStandardized SMA
Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.
BEHAVIORALPatient-driven SMA
Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
Sponsors
Patient-Centered Outcomes Research Institute
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Blinding is not possible with the study design. Patients will not know that there is a difference in SMAs
Intervention model description
The two interventions are based in the Chronic Care Model, which emphasizes whole person care, addressing physical, mental health and psychosocial needs. The conceptual model underlying patient-driven diabetes Shared Medical Appointments is based on self-determination theory (SDT) and principles of whole person care. According to SDT, human motivation and behavior are a function of the social environment and the extent to which that environment supports basic psychological needs shown to enhance self-determined motivation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Patients were recruited into shared medical appointments as part of their usual care for type 2 diabetes by participating practices from January 4, 2019 to September 30, 2021.
Pre-assignment details
Randomization occurred at the practice level via Covariate Constrained Randomization. Patients seeking treatment in a practice assigned to the Standardized or the Patient-Driven condition received that treatment condition. Patients who were deemed ineligible for the study because they had type 1 diabetes or were pregnant during the study were removed from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Standardized SMA: Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model. | 558 |
| 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.
Patient-driven SMA: Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model. | 504 |
| Total | 1,062 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No session data recorded | 14 | 2 |
| Overall Study | Protocol Violation | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Patient-driven SMA | Standardized SMA |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 11.4 | 61.0 years STANDARD_DEVIATION 11.6 | 59.7 years STANDARD_DEVIATION 11.2 |
| Diabetes Distress Scores | 2.2 units on a scale STANDARD_DEVIATION 0.9 | 2.1 units on a scale STANDARD_DEVIATION 1 | 2.2 units on a scale STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 292 Participants | 155 Participants | 137 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 733 Participants | 319 Participants | 414 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 37 Participants | 30 Participants | 7 Participants |
| Hemoglobin A1c | 8.3 % of hemoglobin coated in glucose STANDARD_DEVIATION 2.1 | 8.3 % of hemoglobin coated in glucose STANDARD_DEVIATION 2.1 | 8.3 % of hemoglobin coated in glucose STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 66 Participants | 3 Participants | 63 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants | 51 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 122 Participants | 93 Participants | 29 Participants |
| Race (NIH/OMB) White | 786 Participants | 353 Participants | 433 Participants |
| Sex: Female, Male Female | 625 Participants | 278 Participants | 347 Participants |
| Sex: Female, Male Male | 437 Participants | 226 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Diabetes Distress - Change in Patient Reported Outcomes (PROs)
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
Time frame: At end of 6 group visits (time differs by practice, up to 6 months)
Population: Patients receiving SMAs as part of standard care at practices randomized to delivering either the Standardized or Patient-Driven model
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standardized SMA | Diabetes Distress - Change in Patient Reported Outcomes (PROs) | 1.9 score on a scale | Standard Deviation 0.8 |
| Patient-driven SMA | Diabetes Distress - Change in Patient Reported Outcomes (PROs) | 1.9 score on a scale | Standard Deviation 0.8 |
Comparison: We hypothesized that patients in Patient-Driven SMAs would have greater reductions in Diabetes Distress than those in Standardized SMAs. We expected seeing an effect size of a .6 unit decrease (.30) in Standardized SMAs and 1.2 unit decrease (.60) in Patient-Driven SMAs. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).p-value: 0.04Mixed Models Analysis
Secondary
Change in Patient HbA1c
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
Time frame: At end of 6 group visits (time differs by practice, up to 6 months)
Population: Patients receiving SMAs as part of standard care at practices randomized to delivering either the Standardized or Patient-Driven model
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standardized SMA | Change in Patient HbA1c | 7.8 %HbA1c | Standard Deviation 1.9 |
| Patient-driven SMA | Change in Patient HbA1c | 7.9 %HbA1c | Standard Deviation 1.8 |
Comparison: We hypothesized that patients in the Patient-Driven condition would have a greater reduction in HbA1c than patients in the Standardized condition. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).p-value: 0.82Mixed Models Analysis