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临床试验/NCT04335331
NCT04335331已完成不适用

Prevent Diabetes Mellitus PreDM Clinical Decision Support Intervention in Community Health Centers

Northwestern University1 个研究点 分布在 1 个国家目标入组 7,424 人开始时间: 2020年2月27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
7,424
试验地点
1
主要终点
A1c order

研究概览

简要总结

Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. While clinical decision support (CDS) represents an effective approach for delivering guideline-based care, the potential of this strategy to improve diabetes prevention efforts has not been definitively tested. This study developed the novel Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention and evaluated its impact on clinical outcomes.

详细描述

Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used and few studies have explored how to promote their uptake in practice. One possible approach for increasing adoption of ILI and metformin in primary care includes clinical decision support (CDS), which uses electronic systems to create tailored recommendations for evidence-based clinical care. While a large body of evidence demonstrates that CDS can improve the delivery of other recommended preventive services, this approach has not been definitively studied for ILI and metformin. The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention for community health center patients with prediabetes and overweight/obesity. This novel CDS engages primary care providers and clinical staff to deliver intervention components.

This study tests the potential for CDS to promote diabetes prevention and weight loss efforts in primary care. The current study objectives were to: 1) interview providers about their preferences for CDS focused on prediabetes; 2) develop a novel CDS tool, the Prediabetes CDS (PreDM CDS), promoting evidence-based care for prediabetes; and 3) conduct a pilot evaluation of the novel CDS tool using electronic health record data. Study investigators hypothesize that the proposed PreDM CDS will increase patient's adoption of ILI and metformin, producing modest weight loss and improvements in other cardiometabolic markers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • age ≥18 years old
  • prediabetes
  • two weight measurements during the study period

排除标准

  • The primary exclusion criterion is type 2 diabetes.
  • The following additional criteria will exclude those in whom treatment is potentially harmful or outcomes assessment may be confounded: serum creatinine >1.4mg/dL in women and >1.5mg/dL in men, uncontrolled hypertension (≥180/100mmHg), prior antidiabetic medication orders, and gastric bypass surgery or pregnancy during the evaluation period.

结局指标

主要结局

A1c order

时间窗: 18 Months

Mean differences in rates of hemoglobin A1c orders between treatment arms evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers.

次要结局

  • Weight(18 Months)

研究者

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

Matthew J O'Brien

Associate Professor

Northwestern University

研究点 (1)

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