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临床试验/NCT02199769
NCT02199769已完成不适用

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

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 747 人开始时间: 2014年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
747
试验地点
2
主要终点
Resulted Diabetes Screening Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Study Patients Excluded: will be those who are:
  • 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

结局指标

主要结局

Resulted Diabetes Screening Test

时间窗: 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.

次要结局

  • Pre-diabetes diagnosis(90 days)
  • Time to diabetes testing(12 months)
  • Diabetes Diagnosis(90 days)
  • Ordered Diabetes Screening(90 days)
  • Time to diabetes diagnosis(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Edward Bowen

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (2)

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