Glucose to Goal: A Model to Support Diabetes Management in Primary Care
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|ClinicalTrials.gov Identifier: NCT02715934|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Glucose to Goal Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4994 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Glucose to Goal: A Model to Support Diabetes Management in Primary Care|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 31, 2017|
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.
Other: Glucose 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.
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.
Other: Usual 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.
- 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.
- 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.
- 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.
- 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.
- Problem Assessment in Diabetes-5 (PAID-5) [ Time Frame: As available across 18 months ]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.
- Diabetes Empowerment Scale - Short Form (DES-SF) [ Time Frame: As available across 18 months ]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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715934
|United States, Pennsylvania|
|UPMC Community Medicine, Inc.|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Linda Siminerio, RN, PhD, CDE||University of Pittsburgh|