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Glucose to Goal: A Model to Support Diabetes Management in Primary Care

Glucose to Goal: A Model to Support Diabetes Management in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02715934
Enrollment
4994
Registered
2016-03-22
Start date
2016-04-30
Completion date
2017-12-31
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes Education, Chronic Disease Management, Health Care Delivery, Patient-Centered Medical Home, Primary Care

Brief summary

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.

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.

Interventions

OTHERGlucose to Goal

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.

OTHERUsual Care

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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Provider referralMonitor continuously across 18 monthsThe 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.

Secondary

MeasureTime frameDescription
Patient participationMonitor continuously across 18 monthsPatient 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.

Other

MeasureTime frameDescription
Problem Assessment in Diabetes-5 (PAID-5)As available across 18 monthsPAID 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.
Primary care practice satisfaction with implementation processBaseline, 9 months, 18 monthsThe 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.
Summary of Diabetes Self-care Activities Measure (SDSCA)As available across 18 monthsThis 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.
Diabetes Empowerment Scale - Short Form (DES-SF)As available across 18 monthsTo 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.
Hemoglobin A1cAs available across 18 monthsIn 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026