Assessment of Acute Disease to Reduce Imaging Costs

Study Overview
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Brief Summary
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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.

Official Title
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Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Conditions
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Acute Coronary Syndrome, Pulmonary Embolism

Intervention / Treatment
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* Device: Webtool


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Webtool Output<br>The webtool output group will receive the numeric PTP estimate from webtool output. | Device: Webtool<br>* 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.<br>|
| No Intervention: Standard of Care/No Webtool Output<br>The control group will not receive the numeric PTP estimate. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer-derived, quantitative pretest probability (PTP), Overtesting, Radiation, Intravenous Contrast, Anticoagulation