N/A
N=264
Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone
Kidney Stones
Bottom Line
View on ClinicalTrials.gov: NCT01869647 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Radiation Exposure (Dose-Length-Product) at Baseline — 293.5; 482.1; 915.99 mGy*cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultra low dose CT scan (Radiation); Regular CT or Low Dose CT scan (Radiation); No imaging (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Exposure (Dose-Length-Product) at Baseline |
293.5; 482.1; 915.99 | — |
| SECONDARY Prevalence of Urological Intervention |
19; 24; 3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Exclusion Criteria Patients will be excluded for any one of the following reasons: patients that are
- pregnant
- prisoners
- 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)
Data sourced from ClinicalTrials.gov (NCT01869647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.