Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized SMA | Active Comparator | 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. |
|
| Patient-driven SMA | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized SMA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At end of 6 group visits (time differs by practice, up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At end of 6 group visits (time differs by practice, up to 6 months) |
Not provided
Inclusion Criteria:
Patients must be:
For a practice to be eligible, they must be;
a Federally Qualified Health Center,
a private primary care practice, or
Community Mental Health Center with primary care,
They need to have
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bethany Kwan, PHD, MSPH | University of Colorado, Denver | Principal Investigator |
| Jeanette Waxmonsky, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39049078 | Derived | Holtrop JS, Gurfinkel D, Nederveld A, Reedy J, Rubinson C, Kwan BM. What works in implementing shared medical appointments for patients with diabetes in primary care to enhance reach: a qualitative comparative analysis from the Invested in Diabetes study. Implement Sci Commun. 2024 Jul 24;5(1):82. doi: 10.1186/s43058-024-00608-6. | |
| 38943014 |
Not provided
Not provided
The Investigators will be sharing results in aggregate form via publications and reports to the funder.
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Patients receiving SMAs as part of standard care at practices randomized to delivering either the Standardized or Patient-Driven model | Posted | Mean | Standard Deviation | score on a scale | At end of 6 group visits (time differs by practice, up to 6 months) |
|
N/A - not monitored or collected
There were no adverse health conditions collected as patients were receiving 2 versions of usual care and the intervention did not collect additional data on patients. "All-Cause Mortality", "Serious Adverse Events", and "Other (non-serious AEs) were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bethany Kwan | University of Colorado Anschutz medical Campus | 303-724-5153 | bethany.kwan@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2021 | Feb 4, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2018 | Jun 21, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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."
Not provided
Not provided
Blinding is not possible with the study design. Patients will not know that there is a difference in SMAs
Not provided
|
| Patient-driven SMA | Behavioral | 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. |
|
| Kwan BM, Dickinson LM, Dailey-Vail J, Glasgow RE, Gritz RM, Gurfinkel D, Hester CM, Holtrop JS, Hosokawa P, Lanigan A, Nease DE Jr, Nederveld A, Phimphasone-Brady P, Ritchie ND, Sajatovic M, Wearner R, Begum A, Carter M, Carrigan T, Clay B, Downey D, Koren R, Trujillo SA, Waxmonsky JA. Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial. J Gen Intern Med. 2024 Nov;39(15):2970-2979. doi: 10.1007/s11606-024-08868-7. Epub 2024 Jun 28. |
| 36803773 | Derived | Nederveld A, Phimphasone-Brady P, Gurfinkel D, Waxmonsky JA, Kwan BM, Holtrop JS. Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation. BMC Prim Care. 2023 Feb 17;24(1):52. doi: 10.1186/s12875-023-02006-8. |
| 35906602 | Derived | Holtrop JS, Gurfinkel D, Nederveld A, Phimphasone-Brady P, Hosokawa P, Rubinson C, Waxmonsky JA, Kwan BM. Methods for capturing and analyzing adaptations: implications for implementation research. Implement Sci. 2022 Jul 29;17(1):51. doi: 10.1186/s13012-022-01218-3. |
| 34598702 | Derived | Glasgow RE, Gurfinkel D, Waxmonsky J, Rementer J, Ritchie ND, Dailey-Vail J, Hosokawa P, Dickinson LM, Kwan BM. Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework. BMC Health Serv Res. 2021 Oct 2;21(1):1039. doi: 10.1186/s12913-021-07084-x. |
| 33677530 | Derived | Dickinson LM, Hosokawa P, Waxmonsky JA, Kwan BM. The problem of imbalance in cluster randomized trials and the benefits of covariate constrained randomization. Fam Pract. 2021 Jun 17;38(3):368-371. doi: 10.1093/fampra/cmab007. No abstract available. |
| 31924249 | Derived | Kwan BM, Dickinson LM, Glasgow RE, Sajatovic M, Gritz M, Holtrop JS, Nease DE Jr, Ritchie N, Nederveld A, Gurfinkel D, Waxmonsky JA. The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments. Trials. 2020 Jan 10;21(1):65. doi: 10.1186/s13063-019-3938-7. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Diabetes Distress Scores | Diabetes Distress Scale (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; between 2.0 and 2.9 = reflects moderate distress; > 3.0 = reflects high distress. A total score of >2.0 is considered clinically significant. | Mean | Standard Deviation | units on a scale |
|
| Hemoglobin A1c | Mean | Standard Deviation | % of hemoglobin coated in glucose |
|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| 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 | Patients receiving SMAs as part of standard care at practices randomized to delivering either the Standardized or Patient-Driven model | Posted | Mean | Standard Deviation | %HbA1c | At end of 6 group visits (time differs by practice, up to 6 months) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |