NCT02199769

Brief Summary

This study will focus on the cohort of 20,000 established patients cared for by 31 attending physicians in the outpatient, adult primary care practices at UT Southwestern (two general internal medicine one family medicine and one geriatric practice). The investigators will develop and implement an automated Diabetes Detection Tool (DDT) that does data mining on electronic medical record (EMR) lab data to systematically identify all primary care patients with elevated random plasma glucose results (RPGs) who are at high risk of diabetes and thus in need of further testing. In a cluster-randomized trial, primary care providers will be randomized to either the intervention/DDT arm or usual care. Providers in the intervention arm will receive visit-based, EMR-enabled case identification and real-time decision support. Outcomes will be tracked at a patient level. All subjects will be followed for 12 months to assess rates of follow-up diabetes testing, time to testing, rates of subsequent diabetes diagnosis, and time to diagnosis. The investigators hypothesize that the visit-based provider decision support will be superior to usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
747

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jul 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

July 22, 2014

Last Update Submit

April 24, 2023

Conditions

DiabetesPrediabetes

Keywords

Clinical decision supportDiabetes screening

Outcome Measures

Primary Outcomes (1)

  • Resulted Diabetes Screening Test

    The proportion of patients completing diabetes testing, defined by a resulted A1C or fasting plasma glucose (FPG) within 90 days of the first best practice alert (BPA) fire or the time that the alert would have fired in the control group.

    90 days

Secondary Outcomes (5)

  • Ordered Diabetes Screening

    90 days

  • Time to diabetes testing

    12 months

  • Time to diabetes diagnosis

    12 months

  • Pre-diabetes diagnosis

    90 days

  • Diabetes Diagnosis

    90 days

Study Arms (2)

Clinical Decision Support

EXPERIMENTAL

Visit-based, EMR-enabled case identification and real-time decision support to identify patients without diabetes who have a RBG\>= 125mg/dL and no resulted diabetes screening.

Other: Clinical Decision Support

Usual care

NO INTERVENTION

Diabetes screening/testing and diagnosis per usual care at the discretion of the treating physician.

Interventions

Clinical Decision SupportOTHER

Investigators will develop and implement an automated Diabetes Detection Tool (DDT) that does data mining on EMR lab data to systematically identify all primary care patients with elevated RPGs who are at high risk of diabetes and in need of further diabetes testing/screening.

Clinical Decision Support

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study Patients Included: will be those who are:
  • an established patient of a study PCP;
  • have no diagnosis of diabetes (encounter diagnoses, problem list, medical history);
  • over 18 years of age
  • have at least one RPG≥125mg/dL in the past 2 years

You may not qualify if:

  • Study Patients Excluded: will be those who are:
  • pregnant;
  • under 18 years of age and
  • Patients with an A1C\<6.5% in the past 12 months, as this would indicate the appropriate follow-up was done

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes MellitusPrediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael E Bowen, MD, MPH

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 24, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

April 1, 2016

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)