NCT03461536

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

March 5, 2018

Last Update Submit

October 10, 2022

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (2)

  • CT use

    Whether the patient received CT scan

    During the index emergency department visit

  • Radiation Dose

    Radiation dose in millisieverts

    During the index emergency department visit

Secondary Outcomes (3)

  • Return Visit

    Within 1 week of the ED index visit

  • ED Length of Stay

    During the index emergency department visit

  • Cost

    During the index emergency department visit

Study Arms (2)

Clinical Decision Support

ACTIVE COMPARATOR

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

Behavioral: Ultrasound-first Clinical Decision Support tool

Usual care

NO INTERVENTION

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

Interventions

Ultrasound-first Clinical Decision Support toolBEHAVIORAL

Intervention: The intervention is the CDS tool, which consists of 4 components: 1. Four questions which assess the appropriateness of ultrasound for this patient 2. A link to the evidence 3. Buttons to remove CT scan and order ultrasound 4. 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: 1. Adults aged \>18 and \< 76 2. Non-obese (men \< 285lbs, women \< 250lbs) 3. Low risk of Stone Emergency (Obstructing stone and any of the following: urosepsis, renal deterioration, post kidney transplant, solitary kidney, intractable symptoms) 4. 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.

Clinical Decision Support

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Previous enrollment into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

Related Publications (1)

  • 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.

    PMID: 35986979DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Ralph C Wang, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patients, investigators, and outcome assessors will be blinded to study arm.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 12, 2018

Study Start

January 2, 2019

Primary Completion

December 19, 2019

Study Completion

December 19, 2019

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)