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Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Kline, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01059500
First received: January 28, 2010
Last updated: August 14, 2013
Last verified: August 2013

January 28, 2010
August 14, 2013
January 2010
May 2012   (final data collection date for primary outcome measure)
Primary measurements will test if the webtool works properly(observational): A. Technical reliability B. Accurate low PTP C. Calibration [ Time Frame: After 300 patients enrolled ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059500 on ClinicalTrials.gov Archive Site
A. Quality: B. Effectiveness: C. Efficiency: D. Safety: E. Patient satisfaction: [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Assessment of Acute Disease to Reduce Imaging Costs
Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Acute Coronary Syndrome
  • Pulmonary Embolism
  • Device: Pilot Phase
    Non-intervention phase to test webtool technical reliability, accurate low PTP, and calibration.
  • Device: Intervention group, receive the numeric PTP estimate
    Receive 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.
  • Device: No Intervention
    Standard (no webtool output)
  • Pilot Phase
    First 300 patients will be assigned to arm 1 to test the accuracy of the webtool output.
    Interventions:
    • Device: Pilot Phase
    • Device: No Intervention
  • Experimental: Webtool output
    Phase 2- Intervention, One group will receive the numeric PTP estimate from webtool output, the other groupwill not receive the nemuric PTP estimate
    Intervention: Device: Intervention group, receive the numeric PTP estimate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
850
February 2013
May 2012   (final data collection date for primary outcome measure)

I. 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.

II. Pre-randomization exclusion criteria

  • 12-lead ECG with ST deviation interpreted as acute infarction or ischemia.
  • Known diagnosis of acute PE within previous 24 hours (e.g., call back for overread of a CT scan).
  • "Code STEMI" patients (patients with suspected acute myocardial infarction).
  • Other obvious condition or diagnosis identified by the emergency physician as mandating admission (evidence of circulatory shock, severe hypoxemia, decompensated heart failure, altered mental status, hemorrhage, sepsis syndrome, arrhythmia, trauma, unstable social or psychiatric situation, stroke, aortic disaster, pneumonia ).
  • Myocardial infarction, intracoronary stent placement, or CABG within the previous 30 days.
  • Known cocaine use within past 72 hours, based upon patient or laboratory report.
  • Referral to the emergency department by a personal physician.
  • Patients undergoing voluntary medical clearance for a detox center or any involuntary court or magistrate order.
  • Computer interpretation of the 12-lead ECG containing either "ischemia" or "infarction".
  • Homelessness, out-of-town residence or other condition known to preclude follow-up in 14 days.
  • Patients in police custody or currently incarcerated individuals.
  • Patients who know they are pregnant or in whom a pregnancy test was drawn as part of usual care and was found to be positive.

III. Post-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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059500
1R18HS018519-01
Yes
Jeffrey Kline, Carolinas Healthcare System
Carolinas Healthcare System
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Jeffrey A Kline, MD Carolinas Healthcare System
Carolinas Healthcare System
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP