NCT05587348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

October 14, 2022

Last Update Submit

November 18, 2025

Conditions

Keywords

Diabetes Self Management Education and SupportPeer Support

Outcome Measures

Primary Outcomes (2)

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

    EHR data from the Carolina Data Warehouse. Referral defined as within 30 days of patient seen in of office

    30 days

  • Odds of attending 1 DSMES class

    EHR data -odds of attending 1 DSMES class within 3 months of referral

    3 months

Secondary Outcomes (13)

  • Time from index patient visit to referral to DSMES

    3 months

  • Time to get to DSMES class

    3 months

  • Number of PWD who attended at least 2 DSMES group classes

    3 months

  • Number of PWD who completed the entire DSMES class

    3 months

  • A1c - Baseline

    Baseline

  • +8 more secondary outcomes

Study Arms (4)

1. Best Practice Advisory

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 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.

Behavioral: Best Practice Advisory

2. Silent Best Practice Advisory

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

3. Peer Support

EXPERIMENTAL

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.

Behavioral: Peer Support

4. Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Peer Support

Interventions

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

1. Best Practice Advisory2. Silent Best Practice Advisory
Peer SupportBEHAVIORAL

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

3. Peer Support4. Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Laura Young, MD, PhD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Katrina Donahue, MD, MPH

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

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

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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