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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
Sponsor:
Information provided by (Responsible Party):
Linda Siminerio, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 1, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date April 10, 2018
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 16, 2016)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Glucose to Goal: A Model to Support Diabetes Management in Primary Care
Official Title  ICMJE Glucose to Goal: A Model to Support Diabetes Management in 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Glucose to Goal
  • 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.
    Intervention: Other: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2018)
4994
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
4400
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715934
Other Study ID Numbers  ICMJE 1R34DK106684-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linda Siminerio, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda Siminerio, RN, PhD, CDE University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP