Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)

• ClinicalTrials.gov Identifier: NCT01059500
• Recruitment Status: Completed
• First Posted: February 1, 2010
• Last Update Posted: February 17, 2016
• Sponsor: Atrium Health
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Jeffrey Kline, Atrium Health

Tracking Information

• First Submitted Date: January 28, 2010
• First Posted Date: February 1, 2010
• Last Update Posted Date: February 17, 2016
• Study Start Date: January 2010
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: January 28, 2010): A. Quality: B. Effectiveness: C. Efficiency: D. Safety: E. Patient satisfaction: [ Time Frame: 2 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Acute Disease to Reduce Imaging Costs
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening

Condition

• Acute Coronary Syndrome
• Pulmonary Embolism

Intervention

• 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

• 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 *

• Peitz GW, Troyer J, Jones AE, Shapiro NI, Nelson RD, Hernandez J, Kline JA. Association of body mass index with increased cost of care and length of stay for emergency department patients with chest pain and dyspnea. Circ Cardiovasc Qual Outcomes. 2014 Mar;7(2):292-8. doi: 10.1161/CIRCOUTCOMES.113.000702. Epub 2014 Mar 4.
• Kline JA, Jones AE, Shapiro NI, Hernandez J, Hogg MM, Troyer J, Nelson RD. Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea. Circ Cardiovasc Imaging. 2014 Jan;7(1):66-73. doi: 10.1161/CIRCIMAGING.113.001080. Epub 2013 Nov 25.
• Kline JA, Shapiro NI, Jones AE, Hernandez J, Hogg MM, Troyer J, Nelson RD. Outcomes and radiation exposure of emergency department patients with chest pain and shortness of breath and ultralow pretest probability: a multicenter study. Ann Emerg Med. 2014 Mar;63(3):281-8. doi: 10.1016/j.annemergmed.2013.09.009. Epub 2013 Oct 10.
• Kline JA, Stubblefield WB. Clinician gestalt estimate of pretest probability for acute coronary syndrome and pulmonary embolism in patients with chest pain and dyspnea. Ann Emerg Med. 2014 Mar;63(3):275-80. doi: 10.1016/j.annemergmed.2013.08.023. Epub 2013 Sep 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2010): 850
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01059500
• Other Study ID Numbers: 1R18HS018519-01( U.S. AHRQ Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jeffrey Kline, Atrium Health
• Study Sponsor: Atrium Health
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Jeffrey A Kline, MD; Indiana University School of Medicine

• PRS Account: Atrium Health
• Verification Date: February 2016