Clinical trial NCT02715934: Glucose to Goal: A Model to Support Diabetes Management in Primary Care
Official title: Glucose to Goal: A Model to Support Diabetes Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Education
Chronic Disease Management
Health Care Delivery
Patient-Centered Medical Home
Primary Care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 4994
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

Eligibility criteria: 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

Primary outcomes:
measure: Provider referral
timeFrame: Monitor continuously across 18 months
Secondary outcomes:
measure: Patient participation
timeFrame: Monitor continuously across 18 months
Other outcomes:
measure: Primary care practice satisfaction with implementation process
timeFrame: Baseline, 9 months, 18 months
measure: Hemoglobin A1c
timeFrame: As available across 18 months
measure: Problem Assessment in Diabetes-5 (PAID-5)
timeFrame: As available across 18 months
measure: Diabetes Empowerment Scale - Short Form (DES-SF)
timeFrame: As available across 18 months
measure: Summary of Diabetes Self-care Activities Measure (SDSCA)
timeFrame: As available across 18 months
Locations:
city: Pittsburgh
country: United States
facility: UPMC Community Medicine, Inc.
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Linda Siminerio, RN, PhD, CDE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.