Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)

Wake Forest University (WFU)

Status: Completed

Conditions: Pulmonary Embolism; Acute Coronary Syndrome

Treatments: Device: Webtool

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01059500

1R18HS018519-01

Details and patient eligibility

About

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.

Enrollment: 550 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

550 participants in 2 patient groups

Webtool Output

Experimental group

Description:

The webtool output group will receive the numeric PTP estimate from webtool output.

Treatment:

Device: Webtool

Standard of Care/No Webtool Output

No Intervention group

Description:

The control group will not receive the numeric PTP estimate.