Study of Tomography of Nephrolithiasis Evaluation
Condition: Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared
      to computed tomography (CT) for the initial emergency room evaluation of patients with
      suspected renal colic. The investigators will compare several measures of effectiveness
      including morbidity related to the patient's underlying disease, or complications related to
      delayed diagnosis, patient status regarding pain/missed days of work, and utilization of
      health care resources based on one of three study arms: ultrasound in the Emergency
      Department, ultrasound in Radiology or CT.
    

Detailed description: 
      This is a multi-center, randomized controlled trial of ultrasonography compared with computed
      tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be
      conducted at 15 large urban Emergency Departments (EDs), reflecting geographic,
      socioeconomic, racial and ethnic diversity, and include academic medical centers as well as
      safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in
      the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The
      investigators will then collect precise and unbiased data on a comprehensive range of
      outcomes that will allow assessment of effectiveness, safety, accuracy and cost between
      patients randomized to one the three groups. Taken together, these measures are intended to
      provide the basis for a valid comparison of imaging of patients with suspected urolithiasis
      seen in the ED. The results of this trial could lead to a change in clinical practice that is
      associated with both improved patient outcomes and reduced cost. Broad stakeholder
      involvement from within radiology, emergency medicine and several subspecialty communities
      has been sought to ensure the strategic completion of study aims and to help rapidly
      disseminate the results of the study into clinical practice. This will create a collaborative
      network of EDs willing to act as a laboratory for studying the comparative effectiveness of
      diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of
      conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of
      outcomes that can be expanded to additional imaging tests in the future.
    

Intervention name(s): Point-of-care Ultrasound; Radiology Ultrasound; Radiology CT
Intervention type(s): Other; Radiation; Other
Intervention description(s): Perform ultrasonography in the ED (physician).; Diagnostic ultrasound completed in the radiology department at time 0.; Computed tomography of abdomen completed in the radiology department at time 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: kidney stone; urolithiasis; urinary tract infection; ultrasound; computed tomography; safety; cost; accuracy