Limit Computed Tomography (CT) Scanning in Suspected Renal Colic (Prospective)

March 4, 2020 updated by: Yale University

Validation of a Decision Rule to Limit CT Scanning in Suspected Renal Colic

Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents only 11% of radiologic examinations but is responsible for two-thirds of the ionizing radiation associated with medical imaging in the U.S. Recent estimates suggest that there will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common, non-life-threatening condition for which CT is overused. As many as 12% of people will have a kidney stone in their lifetime, and more than one million per year will present to the emergency department (ED). CT is now a first line test for renal colic, and is very accurate. However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT rarely alters management. A decision rule is needed to determine which patients with suspected renal colic require CT. While the signs and symptoms of renal colic have been shown to be predictable, no rule has yet been rigorously derived or validated to guide CT imaging in renal colic. A subset of patients with suspected renal colic may have a more serious diagnosis or a kidney stone that will require intervention; however the investigators maintain that clinical criteria, point of care ultrasound and plain radiography (when appropriate), will provide a more comparatively effective and safer approach by appropriately limiting imaging.

Study Overview

Status

Completed

Conditions

Detailed Description

Study Aim: The specific aim of this study is to prospectively validate the previously derived decision rule for obtaining a Flank Pain Protocol (FPP) CT scan in suspected renal colic.

The investigators will integrate the derived clinical decision rule from the ongoing retrospective analysis with gestalt clinician pre-test probability, point of care ultrasound, and plain radiography (when appropriate) to prospectively and observationally test the rule at two distinct clinical settings. CT results and 90-day follow-up will be used to determine predefined outcomes.

Study Hypothesis: Prospective observational testing of a clinical decision rule, combined with point of care ultrasound and plain radiography when appropriate, will categorize >85% of patients who will require intervention, validating a decision rule to avoid unnecessary CT.

This amendment comes from recent evidence and work at our institution to develop an "ultra-low dose" CT scan protocol (ULDCT) with an effective radiation dose close to that of a plain film of the abdomen (KUB), or near 1mSv (compared to 8.5mSv in current practice). While we expect the ULDCT to be better than a KUB at localizing and characterizing kidney stones, what is unknown is how the loss in resolution with an ultra-low dose CT protocol might affect this localization and characterization of stones relative to a regular dose CT (current protocol), as well as the ability to find alternate diagnoses. Incorporating this additional imaging study in a subgroup of patients during the observational phase will allow us to determine test characteristics of the ULDCT that will allow incorporation into the prospective phase. This will hopefully provide excellent evidence about how to implement an ultra-low dose CT scan in practice, ultimately leading to a dramatic reduction in radiation exposure for a large number of patients at Yale and other sites.

We filed an amendment 11-15-2011. This amendment comes from recent evidence and work at our institution to develop an "ultra-low dose" CT scan protocol (ULDCT) with an effective radiation dose close to that of a plain film of the abdomen (KUB), or near 1mSv (compared to 8.5mSv in current practice). While we expect the ULDCT to be better than a KUB at localizing and characterizing kidney stones, what is unknown is how the loss in resolution with an ultra-low dose CT protocol might affect this localization and characterization of stones relative to a regular dose CT (current protocol), as well as the ability to find alternate diagnoses. Incorporating this additional imaging study in a subgroup of patients during the observational phase will allow us to determine test characteristics of the ULDCT that will allow incorporation into the prospective phase. This will hopefully provide excellent evidence about how to implement an ultra-low dose CT scan in practice, ultimately leading to a dramatic reduction in radiation exposure for a large number of patients at Yale and other sites.

This amendment comes from recent evidence and work at our institution to develop an "ultra-low dose" CT scan protocol (ULDCT) with an effective radiation dose close to that of a plain film of the abdomen (KUB), or near 1mSv (compared to 8.5mSv in current practice). While we expect the ULDCT to be better than a KUB at localizing and characterizing kidney stones, what is unknown is how the loss in resolution with an ultra-low dose CT protocol might affect this localization and characterization of stones relative to a regular dose CT (current protocol), as well as the ability to find alternate diagnoses. Incorporating this additional imaging study in a subgroup of patients during the observational phase will allow us to determine test characteristics of the ULDCT that will allow incorporation into the prospective phase. This will hopefully provide excellent evidence about how to implement an ultra-low dose CT scan in practice, ultimately leading to a dramatic reduction in radiation exposure for a large number of patients at Yale and other sites.

Future Direction: Ultimately the investigators intend to implement the validated decision rule at both study sites to evaluate further the feasibility, physician acceptance and comparative effectiveness of our rule. Using standard dissemination techniques and integration of the rule into the computerized physician order entry (CPOE) system at our institutions the investigators will determine the actual reduction in the number of FPP CT scans ordered, clinical outcomes based on 90-day follow up, survey of physician acceptance of the rule as well as an comparative effective analysis. The investigators will submit an application at a later date nearing the end of our projected enrollment for this study.

Study Type

Observational

Enrollment (Actual)

635

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Shoreline Medical Center
      • New Haven, Connecticut, United States, 06519
        • Yale University, Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population will be all patients aged 18 or above presenting to the Yale New Haven Hospital (YNHH) ED and Shoreline Medical Center (SMC) ED for whom a FPP CT scan is ordered by the treating physician for suspected renal colic. A total of 800-1000 patients will be enrolled over a 1.5 year period 6-2011 to 1-2013, matching the sex/race/ethnicity makeup of that found for the retrospective study.

The population of the primary catchment area for YNHH is 350,000 and includes a diverse ethnic and cultural mix. Women and minorities are strongly represented in the population. Women represent approximately 51% of the ED population. The racial mix is approximately 50% White, not of Hispanic Origin; 33% Black, not of Hispanic Origin, 15% Hispanic; 1% Asian and 1% other. The ethnicity of SMC patients is mostly White and 54% female.

Description

Inclusion Criteria:

  • Patients who present to the adult YNHH ED and Shoreline Medical Center SMC ED who are

    • 18 years or older,
    • renal colic is suspected upon presentation to the ED suggested by flank pain, back pain, abdominal pain, and/or hematuria, 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:

  • 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) and
    • with a history or physical evidence of recent trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultra Low Dose vs Regular CT Scans
Time Frame: Baseline-90 Days
both the CT results and the follow-up documentation will be reviewed by two separate MD observers who are blinded to both the predictor variables and the outcome of the decision rule. CT results will be categorized as defined above, and intervention as defined above will either be considered present (immediate or delayed) or absent based on follow-up documentation. In the case where there is a discrepancy in the categorization of CT or intervention, a third reviewer will be used as a tie-breaker, with discussion amongst all parties to reach a consensus if this is not clear.
Baseline-90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Christopher L Moore, MD, Yale University School of Medicine, Emergency Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1104008278
  • HS018322 (Other Identifier: Other Federal Funding)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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