Shared Medical Appointments for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Lily Chao, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must be taking: Type 2 diabetes medications

Disqualifiers: Non-verbal, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 1 year

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves youth already prescribed medication for type 2 diabetes, it seems likely that you can continue your current treatment.

What data supports the effectiveness of the treatment Shared Medical Appointments for Type 2 Diabetes?

Research suggests that Shared Medical Appointments (SMAs) can improve blood sugar control and diabetes knowledge in patients with Type 2 Diabetes. These group appointments allow doctors to provide care to multiple patients at once, which can help manage diabetes more effectively. ^{1 2 3 4 5}

Are shared medical appointments safe for people with diabetes?

The research on shared medical appointments for diabetes does not report any specific safety concerns, suggesting they are generally safe for use in humans. ^{1 2 4 6 7}

How does the treatment of shared medical appointments differ from other treatments for type 2 diabetes?

Shared medical appointments for type 2 diabetes involve group sessions where multiple patients receive care and education from a physician at the same time. This approach is unique because it maximizes resources by allowing the physician to deliver consistent care to several patients simultaneously, potentially improving diabetes management and patient education compared to traditional one-on-one appointments. ^{1 3 4 5 7}

What is the purpose of this trial?

The goal of this clinical trial is to learn if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question\[s\] it aims to answer are: * Is shared medical appointments an acceptable care delivery model for this population? * Does shared medical appointment improve psychosocial outcomes for this population? Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

Research Team

Lily Chao, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for English-speaking youths aged 12-18 with type 2 diabetes who are on medication, and their caregivers if they speak English or Spanish. Participants must receive care at CHLA or UCSF and be willing to attend clinic visits, group sessions, and complete surveys.

Inclusion Criteria

Receives care for type 2 diabetes at either CHLA or UCSF

I am a young person who speaks English.

I am willing to go to clinic visits, join group sessions if needed, and fill out surveys.

Exclusion Criteria

Inability or unwillingness of individual to give written informed consent

Pregnancy

I am unable or unwilling to give consent for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend quarterly clinic appointments and group activities, and take surveys as part of the shared medical appointment model

1 year

4 quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Shared Medical Appointments

Trial Overview The TCT2 study is testing whether shared medical appointments are a good way to treat young people with type 2 diabetes. It compares the effectiveness of these group appointments against the usual one-on-one care by looking at how well patients accept this model and its impact on their mental health.

Participant Groups

Group I: Shared Medical Appointment Active Control 1 Intervention

Participants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics.

Group II: Standard Care Placebo Group 1 Intervention

Multidisciplinary team based care every 3 months.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Findings from Research

Shared medical appointments (SMAs) significantly improved key health indicators for diabetes patients, including a reduction in hemoglobin A1c levels by an average of 0.55 percentage points and systolic blood pressure by 5.2 mmHg, based on a review of 17 studies.

Despite these improvements in biophysical outcomes, the effectiveness of SMAs on LDL cholesterol levels was not significant, and there was not enough data to assess their impact on patient experience or healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with diabetes mellitus: a systematic review. Edelman, D., Gierisch, JM., McDuffie, JR., et al.[2022]

Diabetes shared medical appointments (SMAs) significantly improved A1c levels in participants compared to usual care, with reductions of up to 0.53% for those attending at least half of the SMAs, based on a study involving 1537 adults with type 2 diabetes.

While SMAs showed immediate benefits in glycemic control, these improvements were not sustained at the 12-month follow-up, indicating a need for further research on long-term strategies to maintain these gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. Heisler, M., Burgess, J., Cass, J., et al.[2022]

A systematic review of nine randomized trials involving various chronic illnesses (excluding diabetes and mental health) found that shared medical appointments do not negatively impact patient quality of life, knowledge, or satisfaction compared to usual care.

Patients attending shared medical appointments experienced fewer hospital admissions, suggesting potential benefits for healthcare systems, although more rigorous studies with larger sample sizes are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with a nondiabetic physical chronic illness: A systematic review. Kelly, F., Liska, C., Morash, R., et al.[2019]

Patients involved in shared medical appointments showed notable enhancements in their blood sugar levels, indicating improved glycemic control.

This approach suggests that collaborative care models may be effective in managing diabetes and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments and Their Effects on Achieving Diabetes Mellitus Goals in a Veteran Population. Tardi, A., Kapadia, S., Kurpius, M., et al.[2020]

Shared medical appointments (SMAs) may improve glycemic outcomes and diabetes knowledge in patients with type 2 diabetes mellitus (T2DM), based on a review of 19 studies.

However, the effectiveness of SMAs compared to standard care is still unclear due to limited studies and variability in study designs, indicating a need for larger, more standardized research to evaluate their practicality in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments May Be Effective for Improving Clinical and Behavioral Outcomes in Type 2 Diabetes: A Narrative Review. Menon, K., Mousa, A., de Courten, MP., et al.[2019]

Shared medical appointments (SMA) for 30 male veterans with diabetes led to significant improvements in key health metrics, including A1c, blood pressure, and cholesterol levels over a 6-month period, with no hospitalizations reported.

Veteran satisfaction with the SMA approach increased significantly, highlighting its potential as an effective intervention for managing chronic conditions like diabetes in the veteran population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of Shared Medical Appointments in Veterans With Diabetes: A Quality Improvement Study. Omogbai, T., Milner, KA.[2019]

Shared medical appointments can improve education and outcomes for patients with chronic conditions, particularly among the elderly, as shown in several trials.

The effectiveness of shared medical appointments compared to traditional care remains uncertain, as it is unclear if benefits arise from the unique format or simply from increased provider interaction and time spent with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of shared medical appointments in the care of the elderly. Cherniack, EP.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with diabetes mellitus: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with a nondiabetic physical chronic illness: A systematic review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments and Their Effects on Achieving Diabetes Mellitus Goals in a Veteran Population. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments May Be Effective for Improving Clinical and Behavioral Outcomes in Type 2 Diabetes: A Narrative Review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of Shared Medical Appointments in Veterans With Diabetes: A Quality Improvement Study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The use of shared medical appointments in the care of the elderly. [2013]