NCT02715934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,994

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

March 1, 2016

Last Update Submit

April 6, 2018

Conditions

Diabetes Mellitus

Keywords

Diabetes EducationChronic Disease ManagementHealth Care DeliveryPatient-Centered Medical HomePrimary Care

Outcome Measures

Primary Outcomes (1)

  • Provider referral

    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 Outcomes (1)

  • Patient participation

    Monitor continuously across 18 months

Other Outcomes (5)

  • Primary care practice satisfaction with implementation process

    Baseline, 9 months, 18 months

  • Hemoglobin A1c

    As available across 18 months

  • Problem Assessment in Diabetes-5 (PAID-5)

    As available across 18 months

  • +2 more other outcomes

Study Arms (2)

Glucose to Goal

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Glucose to GoalOTHER

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.

Glucose to Goal
Usual CareOTHER

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.

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes
  • Patients referred to diabetes self-management education by their primary care provider
  • Able to read and write English

You may not qualify if:

  • Clinical diagnosis of type 1 or gestational diabetes
  • Unable to speak or read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Community Medicine, Inc.

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • 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.

    PMID: 7555499BACKGROUND

  • 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.

    PMID: 19841892BACKGROUND

  • 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.

    PMID: 12716841BACKGROUND

  • 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.

    PMID: 10895844BACKGROUND

  • 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.

    PMID: 34078203DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linda Siminerio, RN, PhD, CDE

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 22, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

US(1)