Assessment of Acute Disease to Reduce Imaging Costs - Full Text View

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome Pulmonary Embolism	Device: Pilot Phase Device: Intervention group, receive the numeric PTP estimate Device: No Intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Resource links provided by NLM:

MedlinePlus related topics: Diagnostic Imaging Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

A. Quality: B. Effectiveness: C. Efficiency: D. Safety: E. Patient satisfaction: [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]


Enrollment:	850
Study Start Date:	January 2010
Study Completion Date:	February 2013
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pilot Phase First 300 patients will be assigned to arm 1 to test the accuracy of the webtool output.	Device: Pilot Phase Non-intervention phase to test webtool technical reliability, accurate low PTP, and calibration. Device: No Intervention Standard (no webtool output)
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	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.

Arms

Assigned Interventions

Pilot Phase

First 300 patients will be assigned to arm 1 to test the accuracy of the webtool output.

Device: Pilot Phase

Non-intervention phase to test webtool technical reliability, accurate low PTP, and calibration.

Device: No Intervention

Standard (no webtool output)

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

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.

Eligibility


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059500

Locations


United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103

Sponsors and Collaborators

Carolinas Healthcare System

Agency for Healthcare Research and Quality (AHRQ)

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Jeffrey Kline, Research Director, Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT01059500 History of Changes
Other Study ID Numbers:	1R18HS018519-01
Study First Received:	January 28, 2010
Last Updated:	February 15, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Carolinas Healthcare System:


Computer-derived, quantitative pretest probability (PTP) Overtesting Radiation Intravenous Contrast Anticoagulation

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 26, 2016

Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)