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Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-first Clinical Decision Support tool
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nephrolithiasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients who present to the ED with flank or abdominal pain for whom ED provider orders a CT scan for suspected nephrolithiasis

Exclusion Criteria:

- Previous enrollment into the study

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Clinical Decision Support

Usual care

Arm Description

Participants in this arm will receive the study intervention, the clinical decision support.

Participants in this arm will not receive the the clinical decision support tool.

Outcomes

Primary Outcome Measures

CT use
Whether the patient received CT scan
Radiation Dose
Radiation dose in millisieverts

Secondary Outcome Measures

Return Visit
Return visits to ED with hospitalization
ED Length of Stay
ED Length of Stay
Cost
Total cost

Full Information

First Posted
March 5, 2018
Last Updated
October 10, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03461536
Brief Title
Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis
Official Title
Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized trial to determine the effectiveness of a clinical decision support tool on image ordering for patients with suspected nephrolithiasis. Patients who present with acute unilateral flank or abdominal pain in whom emergency department providers suspect nephrolithiasis will receive either the clinical decision support tool or no tool (usual care).
Detailed Description
CT scan is overused for patients who present to the ED with suspected nephrolithiasis (acute flank or abdominal pain). The investigators have developed a clinical decision support (CDS) tool to identify those patients in whom ultrasound is appropriate. The CDS tool is based on the Study of Ultrasonography vs. Computed Tomography for Suspected Nephrolithiasis in the Emergency Department. The goal of this study is to assess the effectiveness of a clinical decision support (CDS) tool to improve advanced imaging for suspected nephrolithiasis in the ED. The investigators hypothesize those randomized to receiving the CDS tool will receive CT less often (and less radiation) compared to those receiving control. Also, the investigators hypothesize those randomized to receiving CDS will have a similar ED length of stay and rate of unexpected ED return as those receiving control. Study design: Randomized trial of a CDS tool embedded in the electronic health record for patients with suspected nephrolithiasis. The study will be conducted at UCSF Department of Emergency Medicine. Study subjects: The investigators will enroll adult patients who present to the UCSF ED who present with "suspected nephrolithiasis", which is defined as those with symptoms of nephrolithiasis for whom an ED provider orders a CT scan for suspected nephrolithiasis. Symptoms of nephrolithiasis include acute unilateral flank and/or abdominal pain, typically described as severe and colicky. The pain is accompanied by nausea, vomiting, and urinary symptoms, such as hematuria. The CT imaging studies emergency physicians typically order for suspected nephrolithiasis include CT scan without contrast; however a substantial minority of patients receive CT scan with contrast, and CT scan with and without contrast for acute flank pain, suspected nephrolithiasis. Sampling, recruiting and retaining subjects: The investigators will enroll consecutive patients who present to the ED with the selection criteria. Those with suspected nephrolithiasis but have an exclusion criteria will be recorded and compared to those who were enrolled. Eligible patients will be randomized to either receiving CDS recommendations or no CDS recommendations. Subjects will not receive informed consent, and will not be contacted by staff. Intervention: The intervention is the CDS tool, which consists of 4 components: Four questions which assess the appropriateness of ultrasound for this patient A link to the evidence Buttons to remove CT scan and order ultrasound If the CT scan order is kept, reasons why ultrasonography is not appropriate The CDS tool will be placed or integrated into EPIC, at the point of order entry. The tool will be triggered by an order for CT to identify or rule out kidney stone. Co-primary outcomes: Proportion of study arm who receive CT, and radiation dose. Proportion of study arm who receive CT is defined as #CT scans ordered/#patients in study arm. Radiation dose will be reported as median radiation dose in mSv. The secondary outcomes will include proportion of patients with an unscheduled return due to missed diagnosis, cost, ED length of stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, investigators, and outcome assessors will be blinded to study arm.
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Decision Support
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive the study intervention, the clinical decision support.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants in this arm will not receive the the clinical decision support tool.
Intervention Type
Behavioral
Intervention Name(s)
Ultrasound-first Clinical Decision Support tool
Intervention Description
Intervention: The intervention is the CDS tool, which consists of 4 components: Four questions which assess the appropriateness of ultrasound for this patient A link to the evidence Buttons to remove CT scan and order ultrasound If the CT scan order is kept, reasons why ultrasonography is not appropriate The CDS tool will be placed or integrated into EPIC, at the point of order entry. The tool will be triggered by an order for CT scan for kidney stone. Appropriateness criteria for ultrasound: Adults aged >18 and < 76 Non-obese (men < 285lbs, women < 250lbs) Low risk of Stone Emergency (Obstructing stone and any of the following: urosepsis, renal deterioration, post kidney transplant, solitary kidney, intractable symptoms) Low risk of clinically significant alternative diagnosis (e.g. appendicitis, cholecystitis, AAA, ovarian torsion) If all responses are affirmative, then the subject should receive US, and US order is provided.
Primary Outcome Measure Information:
Title
CT use
Description
Whether the patient received CT scan
Time Frame
During the index emergency department visit
Title
Radiation Dose
Description
Radiation dose in millisieverts
Time Frame
During the index emergency department visit
Secondary Outcome Measure Information:
Title
Return Visit
Description
Return visits to ED with hospitalization
Time Frame
Within 1 week of the ED index visit
Title
ED Length of Stay
Description
ED Length of Stay
Time Frame
During the index emergency department visit
Title
Cost
Description
Total cost
Time Frame
During the index emergency department visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients who present to the ED with flank or abdominal pain for whom ED provider orders a CT scan for suspected nephrolithiasis Exclusion Criteria: - Previous enrollment into the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph C Wang, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35986979
Citation
Wang RC, Fahimi J, Dillon D, Shyy W, Mongan J, McCulloch C, Smith-Bindman R. Effect of an ultrasound-first clinical decision tool in emergency department patients with suspected nephrolithiasis: A randomized trial. Am J Emerg Med. 2022 Oct;60:164-170. doi: 10.1016/j.ajem.2022.08.015. Epub 2022 Aug 10.
Results Reference
derived

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Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis

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