Study of Tomography of Nephrolithiasis Evaluation (STONE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01451931
First received: October 11, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Urolithiasis
Other: Diagnostic ultrasonography in radiology department
Radiation: CT in Radiology
Other: Ultrasonography in the Emergency Department
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: 1 month ] [ 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 serious adverse events during follow up and any complications, primarily complications that could result from missed diagnoses. We will define this as the rate of severe serious adverse events which includes any of the following diagnoses that occur within 30 days of randomization: renal infarction, renal abscess, urosepsis, ruptured appendicitis, diverticulitis with abscess, bowel ischemia with perforation, ruptured aortic aneurysm, thoracic dissection with ischemia, pneumonia with sepsis, ovarian torsion with necrosis, 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 imaging-related costs within 6 months following each ED encounter, based on patient's randomization to one of the three study arms.


Secondary Outcome Measures:
  • Delayed Diagnoses [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Rates of delayed diagnoses of a serious condition such as appendicitis, diverticulitis, etc. but without severe complications included in the primary outcome.

  • Pain score at each follow-up assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison of pain scores across the three arms of the study at each follow-up assessment.

  • Total days of work lost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total days of work lost within 6 months following randomization.

  • Length of initial Emergency Department stay [ Time Frame: after initial Emergency Department discharge ] [ Designated as safety issue: No ]
  • Emergency Department readmission [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Rate of emergency department readmission within 6 months following randomization.

  • Hospital admission [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Rate of hospital admission within 6 months following randomization.

  • Total days of hospital admission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total days of hospital admission up to 6 months following randomization.

  • Surgical treatments and interventions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Rate of surgical treatments and/or interventions up to 6 months following randomization.

  • Repeat medical imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of repeat medical imaging within 6 months following randomization.

  • Lifetime Attributable Risk of cancer from medical imaging [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Accuracy of diagnoses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Accuracy of initial baseline diagnoses including sensitivity and specificity.

  • Overall quality of life assessment [ Time Frame: 3 month follow-up assessment ] [ Designated as safety issue: No ]
  • Wage loss costs and self-reported health care costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total cost from wage lost and self-reported reported out-of-pocket costs.

  • Rate of Serious Adverse Events (SAEs) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of SAEs regardless of severity or relatedness.

  • Rate of attributable Serious Adverse Events (SAEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Rate of SAEs that are attributable to the randomized imaging test.


Enrollment: 2776
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasonography Emergency Department
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Other: Ultrasonography in the Emergency Department
Perform ultrasonography in the ED (physician).
Experimental: Ultrasonograpy Radiology
Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department.
Other: Diagnostic ultrasonography in radiology department
Diagnostic ultrasound completed in the radiology department at time 0.
Experimental: CT in Radiology
Patient with suspected urolithiasis will receive computed tomography in the radiology department.
Radiation: CT in Radiology
Computed tomography of abdomen completed in the radiology department at time 0.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men or women = or >18 but <76 years of age presenting with acute renal colic
  • Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

Exclusion Criteria:

  • children < 18 years old
  • elderly patients > or = 76 years old
  • pregnancy or planning pregnancy
  • Morbid obesity (>285 pounds in men, >250 pounds in women)
  • patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).
  • history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451931

Locations
United States, California
UCSF at Fresno
Fresno, California, United States, 93701
University of California, Davis
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63130
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
University of Texas Houston Medical Center
Houston, Texas, United States, 77026
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Rebecca Smith-Bindman, MD University of California, San Francisco, Department of Radiology and Biomedical Imaging
Study Chair: Clifford Rosen, MD Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01451931     History of Changes
Other Study ID Numbers: RSB-1002670
Study First Received: October 11, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
kidney stone
urolithiasis
urinary tract infection
ultrasound
computed tomography
safety
cost
accuracy

Additional relevant MeSH terms:
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014