Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Self Management Education and Support, Peer Support
Brief summary
A 3-step project is proposed. Step 1 will test which BPA time point(s) maximize referral rates to DSMES services in the real world clinic setting (Aim 1). Step 2 will utilize that approach within a pilot study of six sites, comparing the effectiveness of peer support to improve attendance to DSMES services (Aim 2). Step 3 will engage stakeholders in designing a future large scale DSMES services trial to improve referral and attendance to DSMES classes.
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..
Interventions
BEHAVIORALBest Practice Advisory
Provider will get Best Practice Advisory or Message from DCES in intervention practices
BEHAVIORALPeer Support
Patients referred to DSMES classes will be randomized to get a peer supporter
BEHAVIORALUsual Care
Patients referred to DSMES classes who get the usual support from their clinic's personnel
Sponsors
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Referred for Diabetes Self-Management Education and Support (DSMES) Placed Through the Electronic Health Record (EHR) | 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 | within 3 months of referral | Number of patients attending 1 DSMES class within 3 months of referral. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Get to DSMES Class | 3 months | EHR data manually collected by chart review reporting the number of days from patient visit to attending DSMES class. |
| Number of PWDM Who Attended at Least 2 DSMES Group Classes | 3 months | EHR data manually collected by chart review for persons with diabetes (PWDM) who attended at least two DSMES classes. |
| Number of PWD Who Completed the Entire DSMES Class | 3 months | EHR data - patients who attended the entire DSMES class series |
| HbA1c - Baseline | Baseline | HbA1c values manually collected by chart review. HbA1C is measured as a percent. |
| Change in HbA1c From Baseline to 3 Months | Baseline, Month 3 | The difference between the HbA1c at baseline and at 3 months from chart review. A negative change indicates an improvement in HbA1c. |
| Change in HbA1c From Baseline to 6 Months | Baseline, Month 6 | The difference between the HbA1c at baseline and at 6 months from chart review. A negative change indicates an improvement in HbA1c. |
| Diabetes Distress - Baseline | 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. . |
| Change in Diabetes Distress From Baseline to 3 Months | Baseline, Month 3 | 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. |
| Diabetes Self-Efficacy Baseline | 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. |
| Change in Diabetes Self-Efficacy From Baseline to 3 Months | Baseline, Month 3 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Young, MD, PhD
UNC Chapel Hill
PRINCIPAL_INVESTIGATORKatrina Donahue, MD, MPH
UNC Chapel Hill
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 171 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5237 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 114 Participants |
| Race (NIH/OMB) Black or African American | 543 Participants |
| Race (NIH/OMB) More than one race | 62 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3471 Participants |
| Region of Enrollment United States | 5408 Participants |
| Sex: Female, Male Female | 3078 Participants |
| Sex: Female, Male Male | 1522 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 1 / 16 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed