PROmoting Diabetes Education and Management Through Peer Support and Team Referral

NCT05587348 | Completed Results

• 2 other identifiers: 22-0357R34DK132571-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Self Management Education and Support; Peer Support

Outcome Measures

Primary Outcomes (2)

• Number of Patients Referred for Diabetes Self-Management Education and Support (DSMES) Placed Through the Electronic Health Record (EHR)

  The number of patients from an EHR data from the Carolina Data Warehouse for Health. Referral defined as within 30 days of patient seen in of office.

  30 days

• Number of Patients Attending 1 DSMES Class

  Number of patients attending 1 DSMES class within 3 months of referral.

  within 3 months of referral

Secondary Outcomes (10)

• Time to Get to DSMES Class

  3 months

• Number of PWDM Who Attended at Least 2 DSMES Group Classes

  3 months

• Number of PWD Who Completed the Entire DSMES Class

  3 months

• HbA1c - Baseline

  Baseline

• Change in HbA1c From Baseline to 3 Months

  Baseline, Month 3

Study Arms (4)

Best Practice Advisory (Aim 1)

EXPERIMENTAL

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 DCES will have access to a list of eligible patients who have upcoming appointments with their primary care providers. The DCES will message the providers about the eligible patients via the electronic health record (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.

Behavioral: Best Practice Advisory

Silent Best Practice Advisory (Aim 1)

PLACEBO COMPARATOR

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

Behavioral: Best Practice Advisory

Peer Support (Aim 2)

EXPERIMENTAL

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.

Behavioral: Peer Support

Usual Care (Aim 2)

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

Interventions

Best Practice Advisory BEHAVIORAL

Provider will get Best Practice Advisory or Message from DCES in intervention practices

Best Practice Advisory (Aim 1); Silent Best Practice Advisory (Aim 1)

Peer Support BEHAVIORAL

Patients referred to DSMES classes will be randomized to get a peer supporter

Peer Support (Aim 2)

Usual Care BEHAVIORAL

Patients referred to DSMES classes who get the usual support from their clinic's personnel

Usual Care (Aim 2)

Eligibility Criteria

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

You may qualify if:

• Primary Care Providers employed at the participating practices

You may not qualify if:

• Primary Care Providers that are not employed at the participating practices
• Adult, English-speaking patients diagnosed with type 2 diabetes who are referred to DSMES classes from a provider at one of the study practices.
• Any patients who are not referred to DSMES classes from the study practices

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

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: Kathleen Mottus, PhD
• Organization: University of North Carolina at Chapel Hill

kmottus@email.unc.edu

919-966-0599

Study Officials

• Laura Young, MD, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• Katrina Donahue, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: September 12, 2023
• Primary Completion: July 14, 2025
• Study Completion: October 14, 2025
• Last Updated: July 8, 2026
• Results First Posted: July 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)