Diabetes Mellitus, Type 2PROMPTNCT05587348
PROmoting Diabetes Education and Management Through Peer Support and Team Referral
A study testing Best Practice Advisory and Peer Support in people with Diabetes Mellitus, Type 2, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Best Practice Advisory and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 14 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Care Providers 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.
Who cannot join
- Primary Care Providers that are not employed at the participating practices
- Any patients who are not referred to DSMES classes from the study practices
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the detailed description
Living with diabetes can be challenging, however Diabetes Self-Management Education and Support (DSMES) is well known to help persons with diabetes (PWDM) learn to cope with the uncertainties of life with diabetes. Unfortunately, DSMES is underutilized in the current health care setting. This is a multifactorial problem with the two largest issues being providers not referring patients and patients not attending the DSMES programs. These programs and the health care workers who support them have the potential to modify the disease course for many PWDM, including potentially modifying long term morbidity and mortality. A feasibility study to test the impact of Best Practice Advisories (BPAs) delivered to the health care provider and the Diabetes Care and Education Specialists (DCES)via the electronic health record when a PWDM is identified as qualifying for DSMES. The investigators will determine if the BPAs influence the time to referral for DSMES as well as the factors that predict whether a patient is referred to DSMES. The investigators also propose to assess the impact of a peer support on motivating PWDM to attend DSMES and make healthier lifestyle choices. The investigators hypothesize that if PWDM are able to connect with a peer who is also living with diabetes, they may be more likely to attend DSMES. Finally, the investigators will assess qualitatively how the health care providers felt about the use of the BPA reminders, explore how the PWDM felt about the utility of the peer supporters, and the overall relevance of the diabetes education they received. From these lessons learned the investigators will work with the stakeholders to design a large, pragmatic randomized trial designed to increase the uptake of DSMES, a vital piece of the diabetes puzzle.
Aim 1. Evaluate the relative impact of BPAs on DSMES services among providers at 6 primary care clinics.The investigators will identify six primary care practices to deploy the suite of tools designed to increase patient referrals to DSMES classes. All six practices will be from within the state of North Carolina. The providers will be a mix of genders, and ages. Providers will be a convenience sample based upon the six practices that are identified to be a part of this study.
Aim 2. Conduct a 6-month pilot of DSMES among 90 PWDM randomized to one of two groups: usual care or peer support. The investigators will identify 90 PWD who are active adult patients with type 2 diabetes from one of the six practices identified in Aim 1.
Aim 3. Engage stakeholders in designing a future large scale DSMES services trial. The investigators will interview providers and patients from Aims 1 and 2 for the qualitative interviews planned in Aim 3.
Practices: Six primary care practices within the UNC Physicians Network (UNCPN) will be recruited. Based upon the strong relationship the investigators have built with the UNCPN over the past decade, the investigators will work with the UNCPN leadership team to identify practices most likely to be interested in participation. The investigators will ensure a diverse group of practices, including a mix of rural and urban locations. Upon identification of the potential practices, the seasoned practice facilitator will arrange lunch and learn sessions within the potential practices, where they will present the project and discuss the requirements of participating. Practices will have the opportunity to discuss participation amongst their team members, and the practice facilitator will follow up with them within a week to determine their interest in enrolling.
Patients: Patients who have been referred for DSMES classes will be consented and randomized to peer support or usual care. PWDM who are randomized to the peer support group will have standard DSMES classes and as well as support via a peer supporter. The no peer support group will receive standard DSMES class only. After a referral for DSMES class has been placed, the research team will contact them to discuss the pilot trial. Multiple recruitment approaches will be used including phone call, letter, email contact via Epic, the Epic patient portal (MyChart) and informational flyers. Patients will be compensated for filling out surveys at baseline, 3 months, 6 months, and for optional focus group participation..
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Best Practice Advisory, Peer Support, Usual Care
- Keywords
- Diabetes Self Management Education and Support, Peer Support
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice AdvisoryBehavioural
Provider will get Best Practice Advisory or Message from DCES in intervention practices
Peer SupportBehavioural
Patients referred to DSMES classes will be randomized to get a peer supporter
Usual CareBehavioural
Patients referred to DSMES classes who get the usual support from their clinic's personnel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Number of Patients Attending 1 DSMES Class
Number of patients attending 1 DSMES class within 3 months of referral.
Measured: within 3 months of referral
Secondary outcomes (10)
Time to Get to DSMES Class
EHR data manually collected by chart review reporting the number of days from patient visit to attending DSMES class.
Measured: 3 months
Number of PWDM Who Attended at Least 2 DSMES Group Classes
EHR data manually collected by chart review for persons with diabetes (PWDM) who attended at least two DSMES classes.
Measured: 3 months
Number of PWD Who Completed the Entire DSMES Class
EHR data - patients who attended the entire DSMES class series
Measured: 3 months
HbA1c - Baseline
HbA1c values manually collected by chart review. HbA1C is measured as a percent.
Measured: Baseline
Change in HbA1c From Baseline to 3 Months
The difference between the HbA1c at baseline and at 3 months from chart review. A negative change indicates an improvement in HbA1c.
Measured: Baseline, Month 3
Change in HbA1c From Baseline to 6 Months
The difference between the HbA1c at baseline and at 6 months from chart review. A negative change indicates an improvement in HbA1c.
Measured: Baseline, Month 6
Diabetes Distress - Baseline
The Diabetes Distress Scale (DDS17) is a 17-item questionnaire assessing the severity of problems of living with diabetes. Participants indicate the degree to which each item impacts their life on a 6-point scale where 1 = not a problem and 6 = a very serious problem. The scores are summed and divided by 17 to generate an average score that can range from 1 to 6. Scores of 3 or more are considered high distress.
.
Measured: Baseline
Change in Diabetes Distress From Baseline to 3 Months
The Diabetes Distress Scale (DDS17) is a 17-item questionnaire assessing the severity of problems of living with diabetes. Participants indicate the degree to which each item impacts their life on a 6-point scale where 1 = not a problem and 6 = a very serious problem. The scores are summed and divided by 17 to generate an average score that can range from 1 to 6. Scores of 3 or more are considered high distress.
Measured: Baseline, Month 3
Diabetes Self-Efficacy Baseline
The Diabetes Self-Efficacy Survey Short Form (DES-SF) is an 8-item questionnaire assessing the ability of a person to self-manage their diabetes. Participants indicate the degree to which they agree with each of the statements on a 5 point scale where 1 = strongly disagree and 5 = strongly agree. The scores are summed and divided by 8 to generate an average score that can range from 1 to 5, with 5 indicating increased self-efficacy.
Measured: Baseline
Change in Diabetes Self-Efficacy From Baseline to 3 Months
The Diabetes Self-Efficacy Survey Short Form (DES-SF) is an 8-item questionnaire assessing the ability of a person to self-manage their diabetes. Participants indicate the degree to which they agree with each of the statements on a 5 point scale where 1 = strongly disagree and 5 = strongly agree. The scores are summed and divided by 8 to generate an average score that can range from 1 to 5 with 5 indicating increased self-efficacy
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start12 Sep 2023
- Primary completion14 Jul 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Young, MD, PhD, Principal investigator, UNC Chapel HillKatrina Donahue, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587348
- Sponsor's protocol ID
- 22-0357
- Other IDs
- R34DK132571-01
- Acronym
- PROMPT
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2022
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROmoting Diabetes Education and Management Through Peer Support and Team Referral
- ClinicalTrials.gov ID
- NCT05587348
- Acronym / sponsor ID
- PROMPT / 22-0357
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Self Management Education and Support, Peer Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Living with diabetes can be challenging, however Diabetes Self-Management Education and Support (DSMES) is well known to help persons with diabetes (PWDM) learn to cope with the uncertainties of life with diabetes. Unfortunately, DSMES is underutilized in the current health care setting. This is a multifactorial problem with the two largest issues being providers not referring patients and patients not attending the DSMES programs. These programs and the health care workers who support them have the potential to modify the disease course for many PWDM, including potentially modifying long term morbidity and mortality. A feasibility study to test the impact of Best Practice Advisories (BPAs) delivered to the health care provider and the Diabetes Care and Education Specialists (DCES)via the electronic health record when a PWDM is identified as qualifying for DSMES. The investigators will determine if the BPAs influence the time to referral for DSMES as well as the factors that predict whether a patient is referred to DSMES. The investigators also propose to assess the impact of a peer support on motivating PWDM to attend DSMES and make healthier lifestyle choices. The investigators hypothesize that if PWDM are able to connect with a peer who is also living with diabetes, they may be more likely to attend DSMES. Finally, the investigators will assess qualitatively how the health care providers felt about the use of the BPA reminders, explore how the PWDM felt about the utility of the peer supporters, and the overall relevance of the diabetes education they received. From these lessons learned the investigators will work with the stakeholders to design a large, pragmatic randomized trial designed to increase the uptake of DSMES, a vital piece of the diabetes puzzle.
Aim 1. Evaluate the relative impact of BPAs on DSMES services among providers at 6 primary care clinics.The investigators will identify six primary care practices to deploy the suite of tools designed to increase patient referrals to DSMES classes. All six practices will be from within the state of North Carolina. The providers will be a mix of genders, and ages. Providers will be a convenience sample based upon the six practices that are identified to be a part of this study.
Aim 2. Conduct a 6-month pilot of DSMES among 90 PWDM randomized to one of two groups: usual care or peer support. The investigators will identify 90 PWD who are active adult patients with type 2 diabetes from one of the six practices identified in Aim 1.
Aim 3. Engage stakeholders in designing a future large scale DSMES services trial. The investigators will interview providers and patients from Aims 1 and 2 for the qualitative interviews planned in Aim 3.
Practices: Six primary care practices within the UNC Physicians Network (UNCPN) will be recruited. Based upon the strong relationship the investigators have built with the UNCPN over the past decade, the investigators will work with the UNCPN leadership team to identify practices most likely to be interested in participation. The investigators will ensure a diverse group of practices, including a mix of rural and urban locations. Upon identification of the potential practices, the seasoned practice facilitator will arrange lunch and learn sessions within the potential practices, where they will present the project and discuss the requirements of participating. Practices will have the opportunity to discuss participation amongst their team members, and the practice facilitator will follow up with them within a week to determine their interest in enrolling.
Patients: Patients who have been referred for DSMES classes will be consented and randomized to peer support or usual care. PWDM who are randomized to the peer support group will have standard DSMES classes and as well as support via a peer supporter. The no peer support group will receive standard DSMES class only. After a referral for DSMES class has been placed, the research team will contact them to discuss the pilot trial. Multiple recruitment approaches will be used including phone call, letter, email contact via Epic, the Epic patient portal (MyChart) and informational flyers. Patients will be compensated for filling out surveys at baseline, 3 months, 6 months, and for optional focus group participation..
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Best Practice Advisory (Aim 1) | Experimental | Behavioral: Best Practice AdvisoryFour 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. |
| Silent Best Practice Advisory (Aim 1) | Placebo comparator | Behavioral: Best Practice AdvisoryTwo practices will not receive the suite of tools, but the lists and BPA will be created and sent to the research team. |
| Peer Support (Aim 2) | Experimental | Behavioral: Peer SupportPatients 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. |
| Usual Care (Aim 2) | Placebo comparator | Behavioral: Usual CarePatients in the 6 clinics who are referred to DSMES classes who enroll in the study will receive the usual support offered by the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary Care Providers 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.
Key exclusion criteria (2 listed)
- Primary Care Providers that are not employed at the participating practices
- Any patients who are not referred to DSMES classes from the study practices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Practice AdvisoryProvider will get Best Practice Advisory or Message from DCES in intervention practices | Behavioural | Best Practice Advisory (Aim 1), Silent Best Practice Advisory (Aim 1) |
| Peer SupportPatients referred to DSMES classes will be randomized to get a peer supporter | Behavioural | Peer Support (Aim 2) |
| Usual CarePatients referred to DSMES classes who get the usual support from their clinic's personnel | Behavioural | Usual Care (Aim 2) |
Primary outcome
Number of Patients Referred for Diabetes Self-Management Education and Support (DSMES) Placed Through the Electronic Health Record (EHR)
Time frame: 30 days
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.
Number of Patients Attending 1 DSMES Class
Time frame: within 3 months of referral
Number of patients attending 1 DSMES class within 3 months of referral.
10 secondary outcomes
Time to Get to DSMES Class
Time frame: 3 months
Number of PWDM Who Attended at Least 2 DSMES Group Classes
Time frame: 3 months
Number of PWD Who Completed the Entire DSMES Class
Time frame: 3 months
HbA1c - Baseline
Time frame: Baseline
Change in HbA1c From Baseline to 3 Months
Time frame: Baseline, Month 3
Change in HbA1c From Baseline to 6 Months
Time frame: Baseline, Month 6
Diabetes Distress - Baseline
Time frame: Baseline
Change in Diabetes Distress From Baseline to 3 Months
Time frame: Baseline, Month 3
Diabetes Self-Efficacy Baseline
Time frame: Baseline
Change in Diabetes Self-Efficacy From Baseline to 3 Months
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Young, MD, PhD principal investigator
UNC Chapel Hill
Katrina Donahue, MD, MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Advisory and Peer Support in people with Diabetes Mellitus, Type 2, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Referred for Diabetes Self-Management Education and Support (DSMES) Placed Through the Electronic Health Record (EHR) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.