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Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)

Primary Purpose

Acute Coronary Syndrome, Pulmonary Embolism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Webtool

About this trial

This is an interventional screening trial for Acute Coronary Syndrome focused on measuring Computer-derived, quantitative pretest probability (PTP), Overtesting, Radiation, Intravenous Contrast, Anticoagulation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Beth Israel Deaconess Medical Center
University of Mississippi Medical Center
Carolinas Medical Center
Forsyth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Webtool Output

Standard of Care/No Webtool Output

Arm Description

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

The control group will not receive the numeric PTP estimate.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficiency--Total Charge of Medical Care

Amount charged for medical care.

Safety--Radiation Dose to the Chest

in millisievert (mSv)

Effectiveness--Length of Stay in Hospital

Effectiveness--Length of Stay Emergency Department

Full Information

NCT ID

NCT01059500

First Posted

January 28, 2010

Last Updated

March 22, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

1. Study Identification

Unique Protocol Identification Number

NCT01059500

Brief Title

Assessment of Acute Disease to Reduce Imaging Costs

Acronym

QUAADRICs

Official Title

Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Pulmonary Embolism

Keywords

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

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Webtool Output

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care/No Webtool Output

Arm Type

No Intervention

Arm Description

The control group will not receive the numeric PTP estimate.

Intervention Type

Device

Intervention Name(s)

Webtool

Intervention Description

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.

Primary Outcome Measure Information:

Title

Efficiency--Mean Cost of Care

Description

Time Frame

Day 30

Secondary Outcome Measure Information:

Title

Efficiency--Total Charge of Medical Care

Description

Amount charged for medical care.

Time Frame

Day 30

Title

Safety--Radiation Dose to the Chest

Description

in millisievert (mSv)

Time Frame

Day 90

Title

Effectiveness--Length of Stay in Hospital

Time Frame

Day 7

Title

Effectiveness--Length of Stay Emergency Department

Time Frame

Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey A Kline, MD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Forsyth Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24594550

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.

Results Reference

derived

PubMed Identifier

24275953

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.

Results Reference

derived

PubMed Identifier

24120629

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.

Results Reference

derived

PubMed Identifier

24070658

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.

Results Reference

derived

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/24275953/

Description

Article "Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea"

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