Trial Outcomes & Findings for PROmoting Diabetes Education and Management Through Peer Support and Team Referral (NCT NCT05587348)
NCT ID: NCT05587348
Last Updated: 2026-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
30 days
Results posted on
2026-07-08
Participant Flow
Six (6) clinics were recruited based on there being a Diabetes Care and Education Specialist co-located in the clinic. Participants for Aim 1 were patients who met the criteria for a referral to Diabetes Self-Management and Support (DSMES). Participants for Aim 2 were participants from Aim 1 that were referred to DSMES and attended the assessment appointment.
Clinics were randomized 2:1 to Best Practice Alert (BPA) or usual referral, stratified by patient demographics. Aim 1 included 5,640 patient records screened under a waiver of informed consent; 5,408 met analysis criteria and were assigned based on clinic randomization. Aim 2 had 79 eligible participants from Aim 1; 32 were randomized 1:1 to peer support or usual care. Aim 3 qualitative interviews were exploratory and did not include primary or secondary outcomes.
Unit of analysis: Clinics
Participant milestones
| Measure |
Best Practice Advisory (Aim 1)
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 Diabetes Care and Education Specialist (DCES) specialist 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two practices will not receive the suite of tools, but the lists and BPA will be created and sent to the research team.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Peer Support (Aim 2)
Patients in any of 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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
Patients in any of the 6 clinics who are referred to DSMES classes who enroll in the study will receive the usual support offered by the clinic.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
Provider Focus Group (Aim 3)
Providers and/or clinic staff from the four best practice advisory group.
|
Diabetes Education Students (Aim 3)
Students from Aim 2 who agreed to participate in interviews.
|
Peer Supporter Interviews (Aim 3)
Study staff who provided peer support in Aim 2.
|
|---|---|---|---|---|---|---|---|
|
Best Practices Advisory (Aim 1)
STARTED
|
3593 4
|
2047 2
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Best Practices Advisory (Aim 1)
COMPLETED
|
3451 4
|
1957 2
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Best Practices Advisory (Aim 1)
NOT COMPLETED
|
142 0
|
90 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Peer Support (Aim 2)
STARTED
|
0 0
|
0 0
|
16 0
|
16 0
|
0 0
|
0 0
|
0 0
|
|
Peer Support (Aim 2)
Completed Month 3 Survey
|
0 0
|
0 0
|
13 0
|
13 0
|
0 0
|
0 0
|
0 0
|
|
Peer Support (Aim 2)
Attended at Least 1 DSMES Class
|
0 0
|
0 0
|
11 0
|
11 0
|
0 0
|
0 0
|
0 0
|
|
Peer Support (Aim 2)
Completed Month 6
|
0 0
|
0 0
|
11 0
|
10 0
|
0 0
|
0 0
|
0 0
|
|
Peer Support (Aim 2)
COMPLETED
|
0 0
|
0 0
|
13 0
|
13 0
|
0 0
|
0 0
|
0 0
|
|
Peer Support (Aim 2)
NOT COMPLETED
|
0 0
|
0 0
|
3 0
|
3 0
|
0 0
|
0 0
|
0 0
|
|
Qualitative Interviews (Aim 3)
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
44 4
|
9 0
|
2 0
|
|
Qualitative Interviews (Aim 3)
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
44 4
|
9 0
|
2 0
|
|
Qualitative Interviews (Aim 3)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PROmoting Diabetes Education and Management Through Peer Support and Team Referral
Baseline characteristics by cohort
| Measure |
Best Practice Advisory (Aim 1)
n=3451 Participants
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
n=1957 Participants
Two practices will not receive the suite of tools, but the lists and BPA will be created and sent to the research team.
|
Total
n=5408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 15.2 • n=9 Participants
|
65.9 years
STANDARD_DEVIATION 16.0 • n=27 Participants
|
64.8 years
STANDARD_DEVIATION 15.5 • n=267 Participants
|
|
Sex: Female, Male
Female
|
1929 Participants
n=9 Participants
|
1149 Participants
n=27 Participants
|
3078 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
1522 Participants
n=9 Participants
|
808 Participants
n=27 Participants
|
2330 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=9 Participants
|
66 Participants
n=27 Participants
|
171 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3346 Participants
n=9 Participants
|
1891 Participants
n=27 Participants
|
5237 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
76 Participants
n=9 Participants
|
38 Participants
n=27 Participants
|
114 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1095 Participants
n=9 Participants
|
543 Participants
n=27 Participants
|
1638 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
2157 Participants
n=9 Participants
|
1314 Participants
n=27 Participants
|
3471 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
123 Participants
n=9 Participants
|
62 Participants
n=27 Participants
|
185 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
3451 Participants
n=9 Participants
|
1957 Participants
n=27 Participants
|
5408 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: This measure only applies to Aim 1.
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.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
n=3451 Participants
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
n=1957 Participants
Two 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)
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Number of Patients Referred for Diabetes Self-Management Education and Support (DSMES) Placed Through the Electronic Health Record (EHR)
|
474 Participants
|
32 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: within 3 months of referralPopulation: This measure only applies to Aim 1.
Number of patients attending 1 DSMES class within 3 months of referral.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
n=3451 Participants
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
n=1957 Participants
Two 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)
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Number of Patients Attending 1 DSMES Class
|
37 Participants
|
32 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This measure only applies to Aim 2. Data reporting was based on patients who attended 1 class.
EHR data manually collected by chart review reporting the number of days from patient visit to attending DSMES class.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=11 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=11 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Time to Get to DSMES Class
|
—
|
—
|
20 days
Interval 2.0 to 48.0
|
22 days
Interval 6.0 to 56.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This measure only applies to Aim 2. Data reporting was based on patients who attended at least 2 classes.
EHR data manually collected by chart review for persons with diabetes (PWDM) who attended at least two DSMES classes.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=11 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=11 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Number of PWDM Who Attended at Least 2 DSMES Group Classes
|
—
|
—
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This measure only applies to Aim 2. Data reporting was based on patients who attended all 5 classes.
EHR data - patients who attended the entire DSMES class series
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=11 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=11 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Number of PWD Who Completed the Entire DSMES Class
|
—
|
—
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This measure only applies to Aim 2. Baseline HbA1c was a point of care plus or minus 1 month of enrollment date. One participant in the Peer Support (Aim 2) arm did not have results present within the required range.
HbA1c values manually collected by chart review. HbA1C is measured as a percent.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=15 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=16 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
HbA1c - Baseline
|
—
|
—
|
10.36 percentage of HbA1c
Standard Deviation 2.91
|
8.43 percentage of HbA1c
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: This measure only applies to Aim 2. Data reporting was based on patients who had HbA1c in the EHR for both Baseline and Month 3.
The difference between the HbA1c at baseline and at 3 months from chart review. A negative change indicates an improvement in HbA1c.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=11 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=10 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to 3 Months
|
—
|
—
|
-2.45 change in percent HbA1c
Standard Deviation 2.42
|
-1.57 change in percent HbA1c
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: This measure only applies to Aim 2. Data reporting was based on patients who had HbA1c in the EHR for both Baseline and Month 6.
The difference between the HbA1c at baseline and at 6 months from chart review. A negative change indicates an improvement in HbA1c.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=11 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=10 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to 6 Months
|
—
|
—
|
-2.65 change in percent HbA1c
Standard Deviation 2.39
|
-0.82 change in percent HbA1c
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: BaselinePopulation: This measure only applies to Aim 2.
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. .
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=16 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=16 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Diabetes Distress - Baseline
|
—
|
—
|
2.42 score on a scale
Standard Deviation 0.96
|
2.42 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: This measure only applies to Aim 2.
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.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=13 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=13 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Change in Diabetes Distress From Baseline to 3 Months
|
—
|
—
|
-0.41 score on a scale
Standard Deviation 0.69
|
-0.34 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: BaselinePopulation: This measure only applies to Aim 2.
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.
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=16 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=16 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Diabetes Self-Efficacy Baseline
|
—
|
—
|
4.01 score on a scale
Standard Deviation 0.58
|
4.02 score on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: This measure only applies to Aim 2.
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
Outcome measures
| Measure |
Best Practice Advisory (Aim 1)
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 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.
Best Practice Advisory: Provider will get Best Practice Advisory or Message from DCES in intervention practices
|
Silent Best Practice Advisory (Aim 1)
Two 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)
n=13 Participants
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.
Peer Support: Patients referred to DSMES classes will be randomized to get a peer supporter
|
Usual Care (Aim 2)
n=13 Participants
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.
Usual Care: Patients referred to DSMES classes who get the usual support from their clinic's personnel
|
|---|---|---|---|---|
|
Change in Diabetes Self-Efficacy From Baseline to 3 Months
|
—
|
—
|
0.38 score on a scale
Standard Deviation 0.66
|
0.02 score on a scale
Standard Deviation 0.47
|
Adverse Events
Best Practice Advisory (Aim 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silent Best Practice Advisory (Aim 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Support (Aim 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care (Aim 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kathleen Mottus, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-0599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place