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Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461536
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ralph Wang, University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
Nephrolithiasis Behavioral: Ultrasound-first Clinical Decision Support tool Not Applicable

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 nephrolithaisis.

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:

  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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patients, investigators, and outcome assessors will be blinded to study arm.
Primary Purpose: Diagnostic
Official Title: Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clinical Decision Support
Participants in this arm will receive the study intervention, the clinical decision support.
Behavioral: Ultrasound-first Clinical Decision Support tool

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.

No Intervention: Usual care
Participants in this arm will not receive the the clinical decision support tool.



Primary Outcome Measures :
  1. CT use [ Time Frame: During the index emergency department visit ]
    Whether the patient received CT scan

  2. Radiation Dose [ Time Frame: During the index emergency department visit ]
    Radiation dose in millisieverts


Secondary Outcome Measures :
  1. Return Visit [ Time Frame: Within 1 week of the ED index visit ]
    Return visits to ED with hospitalization

  2. ED Length of Stay [ Time Frame: During the index emergency department visit ]
    ED Length of Stay

  3. Cost [ Time Frame: During the index emergency department visit ]
    Total cost



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461536


Contacts
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Contact: Angela Wong 415-353-8730 angela.wong@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94122
Contact: Ralph C Wang, MD    510-384-9514    Ralph.wang@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ralph C Wang, MD, MAS University of California, San Francisco
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Responsible Party: Ralph Wang, Associate Professor of Emergency Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03461536    
Other Study ID Numbers: 18-24325
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical