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| ID | Type | Description | Link |
|---|---|---|---|
| R34DK132571-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice Advisory | Behavioral | Provider will get Best Practice Advisory or Message from DCES in intervention practices |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Number of PWDM Who Attended at Least 2 DSMES Group Classes |
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Inclusion Criteria Providers:
Exclusion Criteria Providers:
Inclusion Criteria Patients:
Exclusion Criteria Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Young, MD, PhD | UNC Chapel Hill | Principal Investigator |
| Katrina Donahue, MD, MPH | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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.
Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | Provider Focus Group (Aim 3) | Providers and/or clinic staff from the four best practice advisory group. |
| FG005 | Diabetes Education Students (Aim 3) | Students from Aim 2 who agreed to participate in interviews. |
| FG006 | Peer Supporter Interviews (Aim 3) | Study staff who provided peer support in Aim 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Best Practices Advisory (Aim 1) |
| |||||||||||||
| Peer Support (Aim 2) |
| |||||||||||||
| Qualitative Interviews (Aim 3) |
|
Participants in Peer Support (Aim 2) are not reported separately here because they were a subset of the Best Practices Advisory (Aim 1). Per protocol, baseline characteristics data for Aim 3 were not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This measure only applies to Aim 1. | Posted | Count of Participants | Participants | 30 days |
|
Adverse Events were not monitored/assessed for the study.
All-cause mortality, serious, and other adverse events (AEs) were not prospectively monitored, as the study activities were not expected to pose risk and much of the sample was derived from existing records. AEs were not collected for Aim 3 interviews (no randomization or intervention). One death (Peer Support participant) was identified during 3-month follow-up and is reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 practicesAdditionally, 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Mottus, PhD | University of North Carolina at Chapel Hill | 919-966-0599 | kmottus@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 8, 2025 | Jun 4, 2026 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Peer Support | Behavioral | Patients referred to DSMES classes will be randomized to get a peer supporter |
|
| Usual Care | Behavioral | Patients referred to DSMES classes who get the usual support from their clinic's personnel |
|
EHR data manually collected by chart review for persons with diabetes (PWDM) who attended at least two DSMES classes.
| 3 months |
| Number of PWD Who Completed the Entire DSMES Class | EHR data - patients who attended the entire DSMES class series | 3 months |
| HbA1c - Baseline | HbA1c values manually collected by chart review. HbA1C is measured as a percent. | 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. | 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. | 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. . | 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. | 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. | 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 | Baseline, Month 3 |
| Completed Month 3 Survey |
|
| Attended at Least 1 DSMES Class |
|
| Completed Month 6 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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 |
| OG003 | 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 |
|
|
|
| Primary | Number of Patients Attending 1 DSMES Class | Number of patients attending 1 DSMES class within 3 months of referral. | This measure only applies to Aim 1. | Posted | Count of Participants | Participants | within 3 months of referral |
|
|
|
| Secondary | 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. | This measure only applies to Aim 2. Data reporting was based on patients who attended 1 class. | Posted | Median | Full Range | days | 3 months |
|
|
|
| Secondary | 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. | This measure only applies to Aim 2. Data reporting was based on patients who attended at least 2 classes. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of PWD Who Completed the Entire DSMES Class | EHR data - patients who attended the entire DSMES class series | This measure only applies to Aim 2. Data reporting was based on patients who attended all 5 classes. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | HbA1c - Baseline | HbA1c values manually collected by chart review. HbA1C is measured as a percent. | 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. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | change in percent HbA1c | Baseline, Month 3 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | change in percent HbA1c | 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. . | This measure only applies to Aim 2. | Posted | Mean | Standard Deviation | score on a scale | 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. | This measure only applies to Aim 2. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 |
|
|
|
|
| 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. | This measure only applies to Aim 2. | Posted | Mean | Standard Deviation | score on a scale | 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 | This measure only applies to Aim 2. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 1 | 16 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |