Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone

NCT01869647 | Completed Results DMC

• 2 other identifiers: 13010113155R01H50118322
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stones

Keywords

kidney stones

Outcome Measures

Primary Outcomes (1)

• Radiation Exposure (Dose-Length-Product) at Baseline

  Radiation exposure at baseline was collected using the mean dose length product mGy\*cm.

  Baseline (at enrollment)

Secondary Outcomes (1)

• Prevalence of Urological Intervention

  90 days

Study Arms (3)

"high" likelihood of stone group

ACTIVE COMPARATOR

Subjects in the "high" likelihood of stone group will be eligible to get either ULDCT or "expectant management". The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone. Participants in this group will receive Ultra low dose CT scan.

Radiation: Ultra low dose CT scan

"moderate" likelihood of stone group

ACTIVE COMPARATOR

Subjects in the "moderate" likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient. Participants in this group will receive regular or low dose CT scan.

Radiation: Regular CT or Low Dose CT scan

"low" likelihood of stone group

ACTIVE COMPARATOR

In the "low" likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol. Participants in this group will not receive imaging.

Radiation: No imaging

Interventions

Ultra low dose CT scan RADIATION

Ultra low dose CT scan

"high" likelihood of stone group

Regular CT or Low Dose CT scan RADIATION

Regular CT or Low Dose CT scan

"moderate" likelihood of stone group

No imaging RADIATION

No imaging

"low" likelihood of stone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Chris L. Moore
• Organization: Yale Emergency Medicine

chris.moore@yale.edu

(203)737-3313

Study Officials

• Christopher L Moore, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 5, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 20, 2020
• Results First Posted: September 21, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)