Comparative Effectiveness of Diabetes Shared Medical Appointment Models

NCT03590041 | Completed Results DMC

• 1 other identifier: 17-2377
• Study Type: interventional
• Target: 1,085
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2, Comparative Effectiveness Trial

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Change in Patient HbA1c

  At end of 6 group visits (time differs by practice, up to 6 months)

Study Arms (2)

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.

Behavioral: Standardized SMA

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.

Behavioral: Patient-driven SMA

Interventions

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.

Standardized SMA

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.

Patient-driven SMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be:
• at least 18 years old,
• have Type II Diabetes, and
• receive care in a participating practice.
• 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
• a current panel of at least 150 adult patients with Type 2 Diabetes, and
• access to health educators, Behavioral Health Professionals, and diabetes peer mentors.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (7)

• 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.

  PMID: 39049078 DERIVED

• 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.

  PMID: 38943014 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.

  PMID: 36803773 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.

  PMID: 35906602 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.

  PMID: 34598702 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.

  PMID: 33677530 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.

  PMID: 31924249 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Bethany Kwan
• Organization: University of Colorado Anschutz medical Campus

bethany.kwan@cuanschutz.edu

303-724-5153

Study Officials

• Bethany Kwan, PHD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Jeanette Waxmonsky, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not possible with the study design. Patients will not know that there is a difference in SMAs
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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."

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 18, 2018
• Study Start: January 4, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 31, 2022
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)