Assessment of Acute Disease to Reduce Imaging Costs

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Pulmonary Embolism
• Interventions: Device: Webtool

• Registration Number: NCT01059500
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-02-01
• Primary Completion: 2012-05
• Study Completion: 2013-02
• Results First Submitted: 2016-07-25
• Status Verified: 2022-11
• Results First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Results First Posted: 2023-03-23
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Webtool Output	Webtool	The webtool output group will receive the numeric PTP estimate from webtool output.

Primary Outcome Measures

Name	Time	Method
Efficiency--Mean Cost of Care	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.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States