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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to encourage people with type 2 diabetes to attend diabetes education classes (DSMES). Researchers will test various approaches, including a Best Practice Advisory (BPA) system that alerts doctors to refer patients and peer support to help patients attend classes. The trial includes several groups: one receives usual care, another receives the BPA, and another receives peer support. The trial seeks English-speaking adults with type 2 diabetes who have been referred to DSMES classes by their doctor. As an unphased trial, this study offers a unique opportunity to enhance diabetes education strategies.

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.

What prior data suggests that these methods are safe for diabetes management?

A previous study demonstrated that using a Best Practice Advisory (BPA) in clinics improves diabetes care by ensuring more patients are referred to essential education classes. These classes, known as DSMES, have a strong track record of enhancing health outcomes. No reports indicate harmful effects from the BPA itself, as it primarily involves sending reminders to healthcare providers through electronic records.

Research has shown that peer support programs are safe and offer emotional and social assistance to individuals managing diabetes. These programs connect patients with supporters who understand their challenges, improving diabetes management. Reports suggest that patients benefit from this support without experiencing negative effects.

Overall, both BPA and peer support methods are well-tolerated and focus on enhancing diabetes care through education and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they focus on enhancing diabetes management through innovative approaches. The Best Practice Advisory (BPA) stands out by using electronic health records to automatically prompt healthcare providers to refer patients to Diabetes Self-Management Education and Support (DSMES) classes, potentially increasing referral rates. Meanwhile, the Peer Support approach pairs patients with a peer supporter to encourage class attendance, adding a personalized touch to the usual clinical support. These strategies aim to improve patient engagement and education, which are critical for effective diabetes management.

What evidence suggests that this trial's treatments could be effective for diabetes management?

Research has shown that using a Best Practice Advisory (BPA), which participants in this trial may receive, can increase referrals to diabetes education programs. Studies indicate that these programs improve health outcomes for people with diabetes, such as better blood sugar control and fewer hospital visits. Additionally, Peer Support, another approach tested in this trial, has proven effective. It can lower blood sugar levels and enhance the overall quality of life for those with diabetes. Together, these approaches aim to help people manage their diabetes more effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Laura Young, MD, PhD

Principal Investigator

UNC Chapel Hill

Katrina Donahue, MD, MPH

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]

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]

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]

Citations

1. diabetesjournals.org diabetesjournals.org/care/article/45/2/484/140905/2022-National-Standards-for-Diabetes-Self

2022 National Standards for Diabetes Self-Management ... Numerous studies have proven the benefits of DSMES, which include improved clinical outcomes and quality of life, while reducing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160547/

2022 National Standards for Diabetes Self-Management ... Numerous studies have proven the benefits of DSMES, which include improved clinical outcomes and quality of life, while reducing hospitalizations and healthcare ...

3. cdc.gov cdc.gov/diabetes/pdfs/evaluation-resources/CDC-DSMES-Rapid-Evaluation-Practice-Based-Guide-508.pdf

Implementing and Evaluating Diabetes Self-Management ... In general, evaluating DSMES programs involves assessing the degree to which the program was implemented as planned and intended outcomes were achieved. Exhibit ...

4. researchprotocols.org researchprotocols.org/2025/1/e71038

Implementation and Evaluation of a Best Practice Advisory ... This study aims to develop and evaluate a best practice advisory (BPA) within the electronic medical record (EMR) to reduce racial and ethnic disparities in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05587348

PROmoting Diabetes Education and Management Through ... A feasibility study to test the impact of best practice advisories (BPAs) delivered to the health care provider and the diabetes care and education (DCE) ...

6. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Based on recent data (13,14,16), DSMES results in an average A1C reduction of 0.45–0.57% when compared with usual care for people with type 2 ...