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OpenTrials
Completed

NCT Number: NCT01059500

Assessment of Acute Disease to Reduce Imaging Costs

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Lung Diseases Myocardial Ischemia Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Webtool

Device

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.

Primary outcomes

  1. Efficiency--Mean Cost of Care

    Time frame: Day 30

    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.

Secondary outcomes

  1. Efficiency--Total Charge of Medical Care

    Time frame: Day 30

    Amount charged for medical care.

  2. Safety--Radiation Dose to the Chest

    Time frame: Day 90

    in millisievert (mSv)

  3. Effectiveness--Length of Stay in Hospital

    Time frame: Day 7

  4. Effectiveness--Length of Stay Emergency Department

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Acronym: QUAADRICs

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Feb 1, 2010
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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