NCT01059500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2023

Completed
Last Updated

March 23, 2023

Status Verified

November 1, 2022

Enrollment Period

2.3 years

First QC Date

January 28, 2010

Results QC Date

July 25, 2016

Last Update Submit

March 22, 2023

Conditions

Acute Coronary SyndromePulmonary Embolism

Keywords

Computer-derived, quantitative pretest probability (PTP)OvertestingRadiationIntravenous ContrastAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • Efficiency--Mean Cost of Care

    Only costs at the enrollment hospital will be used, and only for patients who indicate that they did not visit any other hospital at the time of phone follow-up. Costs would exclude unexpected and unrelated events such as trauma. Additionally, estimated costs associated with the time required of the clinician to gather and enter the 17 variables are included.

    Day 30

Secondary Outcomes (4)

  • Efficiency--Total Charge of Medical Care

    Day 30

  • Safety--Radiation Dose to the Chest

    Day 90

  • Effectiveness--Length of Stay in Hospital

    Day 7

  • Effectiveness--Length of Stay Emergency Department

    Day 7

Study Arms (2)

Webtool Output

EXPERIMENTAL

The webtool output group will receive the numeric PTP estimate from webtool output.

Device: Webtool

Standard of Care/No Webtool Output

NO INTERVENTION

The control group will not receive the numeric PTP estimate.

Interventions

WebtoolDEVICE

Webtool provides 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.

Webtool Output

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Positive urine cocaine test.
  • Incarceration within 14 days of enrollment.
  • Patient elopement from medical care (i.e., patients who leave against medical advice).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (4)

  • 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.

    PMID: 24594550DERIVED

  • 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.

    PMID: 24275953DERIVED

  • 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.

    PMID: 24120629DERIVED

  • 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.

    PMID: 24070658DERIVED

Related Links

MeSH Terms

Conditions

Acute Coronary SyndromePulmonary Embolism

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and Thrombosis

Results Point of Contact

Title
jeffrey kline
Organization
indiana university school of medicine
jefkline@iu.edu
317 880 3869

Study Officials

  • Jeffrey A Kline, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 1, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2012

Study Completion

February 1, 2013

Last Updated

March 23, 2023

Results First Posted

March 23, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)