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

Sponsor:	Carolinas Healthcare System
Collaborator:	Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT01059500

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: 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 ]

Estimated Enrollment:	850
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 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.
Experimental: Webtool output Intervention, receive the numeric PTP estimate from webtool output.	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.
No Intervention: Standard (no webtool output)	Device: No Intervention Standard (no webtool output)

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

Contacts

Contact: Jackeline Hernandez

704-355-2612

jackeline.hernandez@carolinas.org

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nathan I Shapiro, MD
Principal Investigator: Nathan I Shapiro, MD
United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
Contact: Alan Jones, MD 601-815-5533 aejones@umc.edu
Contact: Sylvia Dryer 601-815-5533 spowell@umc.edu
Principal Investigator: Alan Jones, MD
United States, North Carolina
Carolinas Medical Center	Recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Jeffrey A Kline, MD
Forsyth Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Darrell Nelson, MD
Principal Investigator: Darrel Nelson, MD

Sponsors and Collaborators

Carolinas Healthcare System

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:

Jeffrey A Kline, MD

Carolinas Healthcare System

More Information

No publications provided

Responsible Party:	Jeffrey A. Kline/ Principal Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT01059500 History of Changes
Other Study ID Numbers:	1R18HS018519-01
Study First Received:	January 28, 2010
Last Updated:	July 5, 2011
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:

Embolism
Pulmonary Embolism
Acute Coronary Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases

Respiratory Tract Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012