Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)

March 22, 2023 updated by: Wake Forest University Health Sciences

Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. This project addresses question of whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients with charted evidence of chest pain and dyspnea. After a validation phase, the main study will randomize patients to either the Standard care group or the Intervention group, which will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Adult (>17 years) ED patient reports a history of chest discomfort and new or worsened shortness of breath or breathing difficulty, documented in the written history of present illness or review of systems.
  • Patient must understand English or have a certified translator present.
  • Physician has ordered or plans to order a 12-lead electrocardiogram.
  • Patient indicates the site hospital was his or her "hospital of choice" in the event of return visit within 14 days.

Randomization Exclusions

  • Positive urine cocaine test.
  • Incarceration within 14 days of enrollment.
  • Patient elopement from medical care (i.e., patients who leave against medical advice).

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Webtool Output
The webtool output group will receive the numeric PTP estimate from webtool output.
Device: Webtool
Webtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications.
No Intervention: Standard of Care/No Webtool Output
The control group will not receive the numeric PTP estimate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency--Mean Cost of Care
Time Frame: Day 30
Only costs at the enrollment hospital will be used, and only for patients who indicate that they did not visit any other hospital at the time of phone follow-up. Costs would exclude unexpected and unrelated events such as trauma. Additionally, estimated costs associated with the time required of the clinician to gather and enter the 17 variables are included.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency--Total Charge of Medical Care
Time Frame: Day 30
Amount charged for medical care.
Day 30
Safety--Radiation Dose to the Chest
Time Frame: Day 90
in millisievert (mSv)
Day 90
Effectiveness--Length of Stay in Hospital
Time Frame: Day 7
Day 7
Effectiveness--Length of Stay Emergency Department
Time Frame: Day 7
Day 7

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Jeffrey A Kline, MD, Indiana University School of 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

Helpful Links

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

January 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18HS018519-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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