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临床试验/NCT03461536
NCT03461536已完成不适用

Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2019年1月2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
388
试验地点
2
主要终点
Radiation Dose

研究概览

简要总结

This is a randomized trial to determine the effectiveness of a clinical decision support tool on image ordering for patients with suspected nephrolithiasis. Patients who present with acute unilateral flank or abdominal pain in whom emergency department providers suspect nephrolithiasis will receive either the clinical decision support tool or no tool (usual care).

详细描述

CT scan is overused for patients who present to the ED with suspected nephrolithiasis (acute flank or abdominal pain). The investigators have developed a clinical decision support (CDS) tool to identify those patients in whom ultrasound is appropriate. The CDS tool is based on the Study of Ultrasonography vs. Computed Tomography for Suspected Nephrolithiasis in the Emergency Department.

The goal of this study is to assess the effectiveness of a clinical decision support (CDS) tool to improve advanced imaging for suspected nephrolithiasis in the ED. The investigators hypothesize those randomized to receiving the CDS tool will receive CT less often (and less radiation) compared to those receiving control. Also, the investigators hypothesize those randomized to receiving CDS will have a similar ED length of stay and rate of unexpected ED return as those receiving control.

Study design: Randomized trial of a CDS tool embedded in the electronic health record for patients with suspected nephrolithiasis. The study will be conducted at UCSF Department of Emergency Medicine.

Study subjects: The investigators will enroll adult patients who present to the UCSF ED who present with "suspected nephrolithiasis", which is defined as those with symptoms of nephrolithiasis for whom an ED provider orders a CT scan for suspected nephrolithiasis. Symptoms of nephrolithiasis include acute unilateral flank and/or abdominal pain, typically described as severe and colicky. The pain is accompanied by nausea, vomiting, and urinary symptoms, such as hematuria. The CT imaging studies emergency physicians typically order for suspected nephrolithiasis include CT scan without contrast; however a substantial minority of patients receive CT scan with contrast, and CT scan with and without contrast for acute flank pain, suspected nephrolithiasis.

Sampling, recruiting and retaining subjects: The investigators will enroll consecutive patients who present to the ED with the selection criteria. Those with suspected nephrolithiasis but have an exclusion criteria will be recorded and compared to those who were enrolled. Eligible patients will be randomized to either receiving CDS recommendations or no CDS recommendations. Subjects will not receive informed consent, and will not be contacted by staff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Patients, investigators, and outcome assessors will be blinded to study arm.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who present to the ED with flank or abdominal pain for whom ED provider orders a CT scan for suspected nephrolithiasis

排除标准

  • Previous enrollment into the study

结局指标

主要结局

Radiation Dose

时间窗: During the index emergency department visit

Radiation dose in millisieverts

CT use

时间窗: During the index emergency department visit

Whether the patient received CT scan

次要结局

  • Return Visit(Within 1 week of the ED index visit)
  • Cost(During the index emergency department visit)
  • ED Length of Stay(During the index emergency department visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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