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Completed

NCT Number: NCT02199769

Reducing Type 2 Diabetes Diagnostic Delays Using Decision Support

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

The growing epidemic of type 2 diabetes affects over 8.3% of the US population and presents a major challenge to healthcare systems and public health. An additional 7 million people have undiagnosed diabetes and over 79 million have pre-diabetes, which if unrecognized and untreated can progress to full-blown diabetes. Although screening and diagnostic tests are routinely available, health systems struggle to diagnose patients with diabetes in a timely manner. In fact, clinical diagnosis lags 8-12 years behind the onset of glucose dysregulation, resulting in diagnostic delays and the presence of diabetes complications at the time of diagnosis. Among patients engaged in clinical care without a known diagnosis of diabetes, nearly all patients have random plasma glucose (RPG) data available which potentially provides valuable, early warning safety signals regarding the need for further diabetes testing. However, elevated glucose values are commonly unrecognized and over 60% of abnormal values are not followed-up with diabetes testing in a timely fashion. Opportunities exist to leverage existing data within electronic medical records (EMR) to identify patients in need of further diabetes testing and develop systems-based solutions to reduce: 1) failures in following-up abnormal glucose tests, 2) delays in diagnosing diabetes, and 3) frequency of missed diagnoses of diabetes.

This proposal will leverage the Epic EMR at the University of Texas Southwestern Medical Center (UTSW) to improve the detection and follow-up testing rates of abnormal glucose values in real-world practice.

The investigators will conduct a cluster randomized, pragmatic trial comparing the effectiveness of a clinical decision support strategy versus usual care to reduce failures in timely follow-up of abnormal RPGs.

The investigators will focus on the cohort of 20,000 established patients cared for by 31 attending physicians in three outpatient, adult primary care practices at UTSW (two general internal medicine one family medicine and one geriatric practice). Primary care providers (PCPs) will be randomized to either the clinical decision support intervention or usual care. Providers in the clinical decision support/intervention arm will receive clinical decision support that identifies abnormal random glucose values and prompts providers to conduct diabetes screening. Outcomes will be tracked at the patient level and 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. Data on study eligibility, patient clinical risk factors and sociodemographics, provider and visit characteristics, and outcomes will be ascertained using the comprehensive Epic EMR. The investigators hypothesize that the visit-based provider decision support will be superior to usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Clinical Decision Support

Other

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.

Primary outcomes

  1. Resulted Diabetes Screening Test

    Time frame: 90 days

    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.

Secondary outcomes

  1. Ordered Diabetes Screening

    Time frame: 90 days

    Proportion of individuals that have diabetes screening test ordered after BPA fires or would have fired in clinical practice

  2. Time to diabetes testing

    Time frame: 12 months

    The time to ordered diabetes testing from the first alert fire or time when alert would have fired in usual care.

  3. Time to diabetes diagnosis

    Time frame: 12 months

    The time to diabetes diagnosis from first alert fire or when it would have fired in usual care.

  4. Pre-diabetes diagnosis

    Time frame: 90 days

    The proportion of patients diagnosed with pre-diabetes.

  5. Diabetes Diagnosis

    Time frame: 90 days

    proportion of patients meeting diabetes diagnostic criteria

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Harnessing the Electronic Medical Record to Reduce Delays in the Diagnosis of Type 2 Diabetes: a Systems-based, Decision Support Approach

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 24, 2014
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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