Study of Tomography of Nephrolithiasis Evaluation (STONE)

• Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Compare morbidity outcomes as they vary by imaging assignment to one the three study arms. The primary outcome data are reports of adverse events during follow up and any complications primarily complications that could result from missed diagnoses. We will define the rate of adverse events as including any of the following: renal infarction, renal abscess, urosepsis, ruptured appendicitis, diverticulitis with abscess, ruptured aortic aneurysm, thoracic dissection with ischemia or death.
  
  

• Radiation Dose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Compare the average effective dose of ionizing radiation based on imaging tests received and patient's randomization status.
  
  
• Cost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Compare the direct health care costs within 9 months following each ED encounter, based on patient's randomization to one of the three study arms.
  
  

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 10 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 RCT of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.