Assessment of Acute Disease to Reduce Imaging Costs

Wake Forest University Health Sciences550 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

550

Conditions

Acute Coronary Syndrome Pulmonary Embolism

Interventions

WebtoolDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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).

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

Outcomes

Primary Outcomes

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.

Time frame: Day 30

Secondary Outcomes

Efficiency--Total Charge of Medical Care

Amount charged for medical care.

Time frame: Day 30

Safety--Radiation Dose to the Chest

in millisievert (mSv)

Time frame: Day 90

Effectiveness--Length of Stay in Hospital

Time frame: Day 7

Effectiveness--Length of Stay Emergency Department

Time frame: Day 7