Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)
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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 |
- 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 ]
- 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 |
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| Contact: Jackeline Hernandez | 704-355-2612 | jackeline.hernandez@carolinas.org |
| 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 | |
| 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, 2013