Diabetes Education and Management for Diabetes

(PROMPT Trial)

Overseen By Jacquie Halladay, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-referred patients

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A 3-step project is proposed. Step 1 will test which BPA time point(s) maximize referral rates to DSMES services in the real world clinic setting (Aim 1). Step 2 will utilize that approach within a pilot study of six sites, comparing the effectiveness of peer support to improve attendance to DSMES services (Aim 2). Step 3 will engage stakeholders in designing a future large scale DSMES services trial to improve referral and attendance to DSMES classes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on diabetes education and management rather than medication changes.

Is peer support for diabetes management safe for humans?

The research on peer support for diabetes management does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the Diabetes Education and Management treatment differ from other diabetes treatments?

This treatment is unique because it emphasizes peer support, where individuals with diabetes help each other manage their condition through emotional and practical support, education, and skills training. This approach complements traditional medical care by providing ongoing, personalized support that can be adapted to different cultural settings and health systems. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Diabetes Education and Management for Diabetes?

Research shows that peer support, a key component of this treatment, can significantly improve diabetes management by providing emotional and practical help, leading to better blood sugar control and overall health outcomes. Studies have found that peer support interventions improve glycemic control and other health indicators, such as cholesterol levels and waist-to-hip ratio, in people with diabetes. ^{1 6 8 9 10}

Who Is on the Research Team?

Katrina Donahue, MD, MPH

Principal Investigator

UNC Chapel Hill

Laura Young, MD, PhD

Principal Investigator

UNC Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adult, English-speaking patients with type 2 diabetes who are referred to Diabetes Self-Management Education and Support (DSMES) classes by primary care providers from the participating practices. Providers not employed at these practices or patients not referred to DSMES from them cannot join.

Inclusion Criteria

Primary Care Providers employed at the participating practices

I am an adult with type 2 diabetes and have been referred to a diabetes education class.

Exclusion Criteria

Doctors who work at other healthcare centers cannot participate.

Any patients who are not referred to DSMES classes from the study practices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

Conduct a 6-month pilot of DSMES among 90 PWDM randomized to usual care or peer support

6 months

Multiple visits as per DSMES class schedule

Stakeholder Engagement

Engage stakeholders in designing a future large scale DSMES services trial

Varies

Follow-up

Participants are monitored for safety and effectiveness after the pilot study

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Best Practice Advisory
• Peer Support

Trial Overview The study tests a Best Practice Advisory (BPA) timing strategy to maximize referrals to DSMES services and compares peer support's effectiveness in improving attendance at these services. It involves three steps: optimizing BPA timing, piloting peer support, and planning a larger trial.

How Is the Trial Designed?

Group I: 3. Peer Support Experimental Treatment 1 Intervention

45 patients in the 6 clinics who are referred to DSMES classes who enroll in the study will be assigned a peer supporter who will work with the participant and encourage attendance to the DSMES classes in addition to the usual support offered by the clinic.

Group II: 1. Best Practice Advisory Experimental Treatment 1 Intervention

Four practices receive a suite of tools intended to increase the rate of referral to DSMES classes for patients with type 2 diabetes. In these four practices, the assigned DCE specialist will have access to a list of eligible patients who have upcoming appointments with their primary care providers. The DCE specialist will message the providers about the eligible patients via the EHR. They will also place a pended order for referral to DSMES class for the eligible patients. The health care provider will be able to either approve or deny the order for the referral Additionally, when an eligible patient presents for an appointment in one of the four intervention clinics, a best practice advisory (BPA) will fire within the EHR and encourage the provider to place a referral for DSMES classes.

Group III: 4. Usual Care Placebo Group 1 Intervention

45 patients in the 6 clinics who are referred to DSMES classes who enroll in the study will receive the usual support offered by the clinic.

Group IV: 2. Silent Best Practice Advisory Placebo Group 1 Intervention

Two practices will not receive the suite of tools, but the lists and BPA will be created and sent to the research team.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Peer support programs can significantly enhance social and emotional support for adults with diabetes, helping them manage their condition more effectively between healthcare visits.

These programs not only assist with daily diabetes management but also promote connections to clinical care, indicating a promising avenue for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Heisler, M.[2022]

In a study involving 1,299 participants with type 2 diabetes, group peer support over 8-12 months led to a small but significant reduction in systolic blood pressure, particularly for those who attended at least one face-to-face session.

Despite the positive impact on blood pressure, there were no significant changes in HbA1c levels or other metabolic and psychological outcomes, suggesting that while peer support may help with blood pressure, its overall effectiveness on diabetes management needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community based peer support in type 2 diabetes: a cluster randomised controlled trial of individual and/or group approaches. Simmons, D., Prevost, AT., Bunn, C., et al.[2022]

Diabetes peer support initiatives in New Zealand, led by organizations like Diabetes New Zealand, have shown potential in assisting individuals with diabetes, particularly through trained lay educators providing personalized support.

Despite the positive feedback on these programs, there has been no quantitative evaluation of their health impact, indicating a need for formal assessment to better understand their effectiveness in diabetes prevention and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Zealand experience in peer support interventions among people with diabetes. Simmons, D., Voyle, J., Rush, E., et al.[2018]

Peer support groups (PSGs) established in community health centers (CHCs) were more effective and sustainable than those in an eye hospital, with 83% of CHC members reporting satisfaction and positive lifestyle changes, such as regular medication adherence and dietary modifications.

The study involved 195 participants attending 53 sessions across 11 PSGs, highlighting the importance of location and support in diabetes management, as attendance declined in the eye hospital group due to barriers like distance and lack of family support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing peer support groups for diabetic retinopathy in India: Lessons learned and way ahead. Gudlavalleti, AG., Gilbert, C., Shukla, R., et al.[2020]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

The role of peer support in diabetes care and self-management. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. [2022]

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

Peer support for self-management of diabetes improved outcomes in international settings. [2022]

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

Impact of community based peer support in type 2 diabetes: a cluster randomised controlled trial of individual and/or group approaches. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Evaluation of peer support education mode for type 2 diabetes control in rural residents]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The New Zealand experience in peer support interventions among people with diabetes. [2018]

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

Building Bridges Through Collaboration and Consensus: Expanding Awareness and Use of Peer Support and Peer Support Communities Among People With Diabetes, Caregivers, and Health Care Providers. [2020]

8. India pubmed.ncbi.nlm.nih.gov

Establishing peer support groups for diabetic retinopathy in India: Lessons learned and way ahead. [2020]

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

The impact of diabetes education and peer support upon weight and glycemic control of elderly persons with noninsulin dependent diabetes mellitus (NIDDM). [2022]

10. England pubmed.ncbi.nlm.nih.gov

Experiences in peer-to-peer training in diabetes mellitus: challenges and implications. [2010]