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临床试验/NCT01869647
NCT01869647已完成不适用

Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone

Yale University2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
264
试验地点
2
主要终点
Radiation Exposure (Dose-Length-Product) at Baseline

研究概览

简要总结

This is the third phase (feasibility and impact) of a three-phase project designed to derive, validate and test the feasibility and impact of implementing clinical decision support to safely limit the use of Computerized Tomography (CT) and its accompanying radiation and cost in emergency department patients with suspected renal colic.

Hypothesis: Using a before and after model, integration of a clinical prediction rule into decisions about imaging in patients with suspected renal colic will result in a reduction of between 25-50% of radiation received from CT scanning in this population, without adverse affects on patient-centered outcomes.

详细描述

Patients that a clinician deems a CT Flank Pain Protocol for suspected kidney stone is warranted based on their usual practice will be eligible for enrollment. Clinicians will be encouraged to page the Research Associate (RA) prior to ordering the CT, and an automatic page will go out for all CT flank pain protocols that are ordered via EPIC. RAs will approach eligible subjects for written informed consent. Subjects who are incapable or unwilling to provide informed consent, including non-English speaking patients will be excluded.

Following written informed consent, eligibility for the S.T.O.N.E. score will be determined.

Subjects that consent to enrollment but have exclusion criteria will be enrolled observationally to determine the performance of the S.T.O.N.E. score and outcomes in these groups, but will not be eligible for alternate imaging pathways.

Subjects who do not have any of the above exclusion criteria will be placed in one of three groups based on the S.T.O.N.E. score (which may be supplemented by gestalt clinician pre-test probability and/or point-of-care ultrasound for hydronephrosis). The groups are low, moderate, or high and correspond to the likelihood of the patient having a kidney stone as described in results from phases I and II.Subjects in the "high" likelihood of stone group will be eligible to get either Ultra Low Dose Computerized Tomography (ULDCT) or "expectant management". The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone. We will attempt to contact these patients at ~1 week after their ED visit, and they will also have the option to contact our study team. If symptoms are persistent for a week or more, subjects may of course pursue further clinical care with the clinician of their choice and this will not be billed to the study.

Subjects in the "moderate" likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Patients 18 or older who present to the adult YNHH ED, Saint Raphael Campus ED or SMC ED in whom renal colic is suspected upon presentation, and the physician intends to order a CT FPP study for suspicion of a kidney stone. Members of all ethnic and racial groups are eligible.

排除标准

  • Exclusion Criteria Patients will be excluded for any one of the following reasons: patients that are
  • unable or unwilling to consent (including non-English speaking)
  • with a history or physical evidence of recent trauma
  • renal colic not suspected by clinician
  • Patients with the following will not be eligible for alternate imaging, but will be enrolled observationally:
  • evidence of infection (leucocytes in urine, fever)
  • pre-existing renal disease (including creatinine 1.5 or greater)
  • prior urologic intervention
  • active malignancy (within last 6 months)

结局指标

主要结局

Radiation Exposure (Dose-Length-Product) at Baseline

时间窗: Baseline (at enrollment)

Radiation exposure at baseline was collected using the mean dose length product mGy\*cm.

次要结局

  • Prevalence of Urological Intervention(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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