- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02715934
Glucose to Goal: A Model to Support Diabetes Management in Primary Care
April 6, 2018 updated by: Linda Siminerio, University of Pittsburgh
Diabetes education is a very important part of diabetes care.
Most people with diabetes receive care in primary care practices where diabetes education is not always available.
This project tests a model designed to improve access to diabetes education services.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evidence that diabetes self-management education (DSME) can improve health outcomes has repeatedly been shown and is considered to be a critical component of care.
Diabetes educators are highly skilled at addressing diabetes-related clinical and behavioral needs through DSME, but engagement with diabetes educators is underutilized.
It has been suggested that poor referral practices and the way in which DSME service is delivered are the problems.
Most patients receive diabetes care in primary care yet most DSME programs are distinctly separate from primary care practice.
This limits care coordination and diabetes educator access to amenities currently available to primary care.
Efforts are underway to change the US health care paradigm with a focus on quality in primary care that includes practice redesign, population management, and communication through electronic medical records.
The purpose of this application is to evaluate the deployment of Glucose to Goal, a model relying on a systematic redesign of practice that links diabetes educators services with primary care.
This will be compared to the traditional process for DSME delivery, without the direct connection to primary care processes, for an eighteen month period.
The hypothesis is that the proportion of primary care provider referrals and patient utilization of diabetes educator services from primary care practices participating in Glucose to Goal will be higher compared to those associated with traditional DSME.
It is anticipated that this model will appeal to primary care providers, demonstrate a feasible approach to offering diabetes education in the current health environment, and set the stage for future testing of the model, namely its impact on meaningful improvements on diabetes outcomes and cost-effectiveness.
Study Type
Interventional
Enrollment (Actual)
4994
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Community Medicine, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes
- Patients referred to diabetes self-management education by their primary care provider
- Able to read and write English
Exclusion Criteria:
- Clinical diagnosis of type 1 or gestational diabetes
- Unable to speak or read English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucose to Goal
Three diabetes educators will be assigned to the Glucose to Goal/experimental arm.
The educators will each identify two primary care practices of mid to large size to participate in the Glucose to Goal intervention.
Patients will not be formally recruited or enrolled.
Rather, information documented in the electronic medical record system will be extracted to evaluate patient-level outcomes.
Based on a random sampling of mid to large size primary care practices in study communities, an estimated 2,200 patients with diabetes per study group will meet eligibility criteria for DSME referral.
|
The Glucose to Goal intervention applies elements of the Patient Centered Medical Home (i.e., practice design, decision support, population management, etc) to diabetes education services and operationalizes the current DSME objectives in the primary care setting.
|
Other: Control Group
Two usual care diabetes educators will each identify three primary care practices of mid to large size to include in the control arm and participate in the usual care intervention.
Uneven group assignment accounts for the amount of time (one day equivalent/per week) that the intervention diabetes educators will devote to each primary care practice versus the full-time availability of the usual care diabetes educators to see patients at the outpatient, hospital-based program.
Like the experimental arm, an estimated 2,200 patients with diabetes will meet eligibility criteria for DSME referral.
Patients will not be formally recruited or enrolled into the control arm; data will be extracted from the electronic medical record system to evaluate patient-level outcomes.
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The control group will follow the traditional DMSE delivery model, which includes primary care providers referring patients to an outpatient, hospital-based diabetes educator for DSME, but in a passive manner (i.e., without proactive patient identification), which is the usual process for referrals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider referral
Time Frame: Monitor continuously across 18 months
|
The proportion of provider referrals for DSME divided by the total number of patients eligible for a referral.
Patients will be considered eligible for referral if they were seen by their primary care provider during the intervention period and the provider did not contraindicate DSME for any reason.
Referrals (eligibility for and made) will be tracked through electronic medical record review.
|
Monitor continuously across 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient participation
Time Frame: Monitor continuously across 18 months
|
Patient participation will be reported as the proportion of patients who participate in DSME divided by the total number of eligible patients from each participating primary care practice during the study period and will take into account patterns and frequency of visits.
Patients will be considered eligible if they have received a referral to DSME from their primary care provider.
Patients will be offered the opportunity to meet with the diabetes educator for a series of DSME visits and these visits will occur in individual or group format, depending on space, scheduling, etc.
The number and content of the visits will be patient-centered (driven by the patient).
Patients eligible for and participating in DSME will be tracked through electronic medical record review.
|
Monitor continuously across 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary care practice satisfaction with implementation process
Time Frame: Baseline, 9 months, 18 months
|
The research team will collect data on the implementation process at the primary care practice orientation and team huddles at the mid-point and end of the intervention.
During the practice orientation, the manner in which practices negotiate adoption of the key features of Glucose to Goal will be documented.
With the assistance of trained qualitative researchers, mid and end point team huddles will be conducted using a focus group format to review experiences, examine challenges and barriers, identify best practices, and gauge provider and diabetes educator satisfaction.
|
Baseline, 9 months, 18 months
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Hemoglobin A1c
Time Frame: As available across 18 months
|
In preparation for a larger scale, longitudinal study testing the effectiveness of the Glucose to Goal model on diabetes control, hemoglobin A1c values and other key diabetes markers (i.e., lipid panels, blood pressure) that are documented in the electronic medical record system during the study period will be extracted and analyzed.
Dates and frequency of tests, absolute values, and whether values were within recommended target ranges will be documented.
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As available across 18 months
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Problem Assessment in Diabetes-5 (PAID-5)
Time Frame: As available across 18 months
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PAID is a measure of psychosocial adjustment and diabetes emotional distress.
Psychometric reports to date on PAID have shown it to have consistently high internal and test-retest reliability; correlate strongly with a wide range of theoretically related constructs such as general emotional distress, depression, diabetes self-care behaviors, diabetes coping, and health beliefs; and be a statistically significant predictor of glycemic control (Polonsky et al, 1995).
The 5-item version (McGuire et al, 2010) will be administered at DSME visits.
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As available across 18 months
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Diabetes Empowerment Scale - Short Form (DES-SF)
Time Frame: As available across 18 months
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To allow for a brief overall assessment of diabetes-related psychosocial self-efficacy, the DES-SF, an 8-item scale, was developed based on the original 37-item DES (Anderson et al, 2003).
DES-SF items address participants' perceived ability to assess readiness to change, set/reach goals, overcome barriers, cope with emotions, manage stress, obtain support, motivation, and make cost/benefit decisions.
The DES-SF will be administered at DSME visits.
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As available across 18 months
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Summary of Diabetes Self-care Activities Measure (SDSCA)
Time Frame: As available across 18 months
|
This instrument will be used to evaluate self-care with questions about number of days in a week that the participant reports self-care behaviors related to general diet, specific diet, exercise, blood glucose testing, foot care, and smoking.
Correlations with other measures of diet and exercise generally support validity of SDSCA subscales (Toobert et al, 2000).
The SDSCA will be administered at DSME visits.
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As available across 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linda Siminerio, RN, PhD, CDE, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
- Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
- McGuire BE, Morrison TG, Hermanns N, Skovlund S, Eldrup E, Gagliardino J, Kokoszka A, Matthews D, Pibernik-Okanovic M, Rodriguez-Saldana J, de Wit M, Snoek FJ. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010 Jan;53(1):66-9. doi: 10.1007/s00125-009-1559-5. Epub 2009 Oct 20.
- Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.
- Krall JS, Kanter JE, Ruppert KM, Arena VC, Solano FX, Siminerio LM. Effect of a Primary Care-Based Diabetes Education Model on Provider Referrals and Patient Participation. Sci Diabetes Self Manag Care. 2021 Feb;47(1):74-84. doi: 10.1177/0145721720981840.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
March 1, 2016
First Submitted That Met QC Criteria
March 16, 2016
First Posted (Estimate)
March 22, 2016
Study Record Updates
Last Update Posted (Actual)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 6, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34DK106684-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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