Clinical trial NCT01059500: Assessment of Acute Disease to Reduce Imaging Costs
Official title: Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Pulmonary Embolism
Keywords: Computer-derived, quantitative pretest probability (PTP)
Overtesting
Radiation
Intravenous Contrast
Anticoagulation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-02-01
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

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).

Primary outcomes:
measure: Efficiency--Mean Cost of Care
timeFrame: Day 30
Secondary outcomes:
measure: Efficiency--Total Charge of Medical Care
timeFrame: Day 30
measure: Safety--Radiation Dose to the Chest
timeFrame: Day 90
measure: Effectiveness--Length of Stay in Hospital
timeFrame: Day 7
measure: Effectiveness--Length of Stay Emergency Department
timeFrame: Day 7
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Indiana University School of Medicine
name: Jeffrey A Kline, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.