N/A
N=541
Assessment of Acute Disease to Reduce Imaging Costs
Acute Coronary Syndrome · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT01059500 ↗Enrolled (actual)
541
Serious AEs
15.3%
Results posted
Mar 2023
Primary outcome: Primary: Efficiency--Mean Cost of Care — 3933; 2761 US Dollars
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Webtool (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficiency--Mean Cost of Care |
3933; 2761 | — |
| SECONDARY Efficiency--Total Charge of Medical Care |
16413; 11916 | — |
| SECONDARY Safety--Radiation Dose to the Chest |
5.2; 4.2 | — |
| SECONDARY Effectiveness--Length of Stay in Hospital |
31.7; 27.1 | — |
| SECONDARY Effectiveness--Length of Stay Emergency Department |
5.7; 5.7 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01059500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.