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Diabetes Education and Management for Diabetes (PROMPT Trial)

N/A

Waitlist Available

Led By Katrina Donahue, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 6

Summary

This trial seeks to improve referral & attendance to diabetes self-management services, by testing the best time points for referral & by conducting a pilot study to compare the effectiveness of peer support.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on education and management strategies rather than medication, it does not have typical medical side effects. However, participants may experience stress or time constraints due to additional commitments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Odds of attending 1 DSMES class

Odds of referral for DSMES Placed through the Electronic Health Record (EHR)

Secondary study objectives

A1c - Baseline

Change in A1c from baseline to 3 months

Change in A1c from baseline to 6 months

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 3. Peer SupportExperimental Treatment1 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 AdvisoryExperimental Treatment1 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 CarePlacebo Group1 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 AdvisoryPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Best Practice Advisory

2022

N/A

~160