Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059500
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jeffrey Kline, Atrium Health

Tracking Information
First Submitted Date  ICMJE January 28, 2010
First Posted Date  ICMJE February 1, 2010
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01059500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
A. Quality: B. Effectiveness: C. Efficiency: D. Safety: E. Patient satisfaction: [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Acute Disease to Reduce Imaging Costs
Official Title  ICMJE Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Acute Coronary Syndrome
  • Pulmonary Embolism
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2010)
850
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059500
Other Study ID Numbers  ICMJE 1R18HS018519-01( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Kline, Atrium Health
Study Sponsor  ICMJE Atrium Health
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Jeffrey A Kline, MD Indiana University School of Medicine
PRS Account Atrium Health
Verification Date February 2016

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