PROmoting Diabetes Education and Management Through Peer Support and Team Referral

Diabetes Mellitus, Type 2 Clinical Trial

— PROMPT  

Official title:

PROmoting Diabetes Education and Management Through Peer Support and Team Referral

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587348
• Other study ID #: 22-0357
• Secondary ID: 1R34DK132571-01
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Kathleen Mottus, PhD
• Phone: 919-966-0599
• Email: kmottus[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Step 3 will engage stakeholders in designing a future large scale DSMES services trial to improve referral and attendance to DSMES classes.

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 (DCE) specialists 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Providers:

• Primary Care Providers employed at the participating practices

Exclusion Criteria Providers:

• Primary Care Providers that are not employed at the participating practices

Inclusion Criteria Patients:

• Adult, English-speaking patients diagnosed with type 2 diabetes who are referred to DSMES classes from a provider at one of the study practices.

Exclusion Criteria Patients:

• Any patients who are not referred to DSMES classes from the study practices

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Best Practice Advisory
Provider will get Best Practice Advisory or Message from DCE in intervention practices
• Peer Support
Patients referred to DSMES classes will be randomized to get a peer supporter

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Odds of attending 1 DSMES class	EHR data -odds of attending 1 DSMES class within 3 months of referral	3 months
Secondary	Time from index patient visit to referral to DSMES	EHR data- number of days from patient visit to referral placed in EMR	3 months
Secondary	Time to get to DSMES class	EHR data- number of days from patient visit to attending DSMES class	3 months
Secondary	Number of PWD who attended at least 2 DSMES group classes	EHR data - patients who attended two DSMES classes	3 months
Secondary	Number of PWD who completed the entire DSMES class	EHR data - patients who attended the entire DSMES class series	3 months
Secondary	A1c - Baseline	Pulled from EHR data	Baseline
Secondary	Change in A1c from baseline to 3 months	Pulled from EHR data	Baseline, Month 3
Secondary	Change in A1c from baseline to 6 months	Pulled from EHR data	Baseline, Month 6
Secondary	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.; The DDS17 has 4 sub-scores.; A. Emotional burden, uses items 1,4, 7, 10, and 14 summed and divided by 5 to generate an average score.; B. Physician distress, uses items 2, 5, 11, and15 summed and divided by 4 to generate an average score.; C. Regimen distress, uses item 6, 8, 3, 12, and 16 summed and divided by 5 to generate an average score.; D. Interpersonal distress, uses item 9,13, and 17 summed and divided by 3 to generate an average score.; .	Baseline
Secondary	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.; The DDS17 has 4 sub-scores.; A. Emotional burden, uses items 1,4, 7, 10, and 14 summed and divided by 5 to generate an average score.; B. Physician distress, uses items 2, 5, 11, and15 summed and divided by 4 to generate an average score.; C. Regimen distress, uses item 6, 8, 3, 12, and 16 summed and divided by 5 to generate an average score.; D. Interpersonal distress, uses item 9,13, and 17 summed and divided by 3 to generate an average score.	Baseline, Month 3
Secondary	Change in Diabetes Distress from baseline to 6 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.; The DDS17 has 4 sub-scores.; A. Emotional burden, uses items 1,4, 7, 10, and 14 summed and divided by 5 to generate an average score.; B. Physician distress, uses items 2, 5, 11, and15 summed and divided by 4 to generate an average score.; C. Regimen distress, uses item 6, 8, 3, 12, and 16 summed and divided by 5 to generate an average score.; D. Interpersonal distress, uses item 9,13, and 17 summed and divided by 3 to generate an average score.	Baseline, Month 6
Secondary	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.	Baseline
Secondary	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	Baseline, Month 3
Secondary	Change in Diabetes Self-Efficacy from baseline to 6 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.	Baseline, Month 6