Assessment of Acute Disease to Reduce Imaging Costs

Acute Coronary Syndrome Clinical Trial

— QUAADRICs  

Official title:

Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059500
• Other study ID #: 1R18HS018519-01
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: November 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: February 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Embolism
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency--Mean Cost of Care	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	Efficiency--Total Charge of Medical Care	Amount charged for medical care.	Day 30
Secondary	Safety--Radiation Dose to the Chest	in millisievert (mSv)	Day 90
Secondary	Effectiveness--Length of Stay in Hospital		Day 7
Secondary	Effectiveness--Length of Stay Emergency Department		Day 7

External Links

•   Article "Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea"