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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Point-of-care Ultrasound | Experimental | Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician). |
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| Radiology Ultrasound | Experimental | Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0. |
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| Radiology CT | Experimental | Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care Ultrasound | Other | Perform ultrasonography in the ED (physician). |
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| Measure | Description | Time Frame |
|---|---|---|
| High Risk Diagnosis With Complication | Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality. | 30 days from baseline |
| Cumulative Radiation Exposure | Baseline plus 6 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| ED Length of Stay | Baseline visit excluding hospitalization | |
| Return Visits to ED or Hospital | 6 months post-baseline | |
| Accuracy for Stones by Arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Smith-Bindman, MD | University of California, San Francisco, Department of Radiology and Biomedical Imaging | Principal Investigator |
| Clifford Rosen, MD | Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF at Fresno | Fresno | California | 93701 | United States | ||
| University of California, Davis |
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| ID | Title | Description |
|---|---|---|
| FG000 | Point-of-care Ultrasound | Patient with suspected urolithiasis received ultrasonography performed in the emergency department. Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician). |
| FG001 | Radiology Ultrasound |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Radiology Ultrasound |
| Radiation |
Diagnostic ultrasound completed in the radiology department at time 0. |
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| Radiology CT | Other | Computed tomography of abdomen completed in the radiology department at time 0. |
|
| Up to 6 month follow-up for stone passage |
| Sacramento |
| California |
| 95817 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63130 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| University of Texas Houston Medical Center | Houston | Texas | 77026 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department. Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0. |
| FG002 | Computed Tomography | Patient with suspected urolithiasis received computed tomography in the radiology department. CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0. |
| Baseline Data Collection |
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| 6-month Follow up |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Point-of-care Ultrasound | Patient with suspected urolithiasis received ultrasonography performed in the emergency department. Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician). |
| BG001 | Radiology Ultrasound | Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department. Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0. |
| BG002 | Computed Tomography | Patient with suspected urolithiasis received computed tomography in the radiology department. CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| History of Kidney Stones or Cancer | Number | number of participants |
| ||||||||||||||||
| Self-Reported Pain Score | Range 0-10, higher numbers indicate more severe pain | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | High Risk Diagnosis With Complication | Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality. | Posted | Number | participants | 30 days from baseline |
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| Primary | Cumulative Radiation Exposure | Posted | Mean | Standard Deviation | mSv | Baseline plus 6 months post-baseline |
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| Secondary | ED Length of Stay | Posted | Median | Inter-Quartile Range | Hours | Baseline visit excluding hospitalization |
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| Secondary | Return Visits to ED or Hospital | Posted | Number | Number of visits | 6 months post-baseline |
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| Secondary | Accuracy for Stones by Arm | Posted | Number | 95% Confidence Interval | Percent probability | Up to 6 month follow-up for stone passage |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Point-of-care Ultrasound | Patient with suspected urolithiasis received ultrasonography performed in the emergency department. Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician). | 3 | 908 | 110 | 908 | ||
| EG001 | Radiology Ultrasound | Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department. Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0. | 4 | 893 | 92 | 893 | ||
| EG002 | Computed Tomography | Patient with suspected urolithiasis received computed tomography in the radiology department. CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0. | 5 | 958 | 101 | 958 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Renal Insuff/ Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Small Bowel Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ovarian Torsion | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Acute Allergy | Immune system disorders | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated Urosepsis Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Other - Various Unrelated | Renal and urinary disorders | Non-systematic Assessment | Other various unrelated adverse effects, not categorized during study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Smith-Bindman | University of California, San Francisco | 415-353-4946 | rebecca.smith-bindman@ucsf.edu |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| No Kidney Stone |
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