Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain

November 8, 2007 updated by: PREtest Consult

Randomized, Controlled Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain

The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Specifically, the study will examine whether the PREtest Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly reduce the use of chest pain unit evaluation in very low risk emergency department (ED) patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce unnecessary procedures and lower hospital costs and will examine patient satisfaction of patients with whom pretest probability assessment was used compared to those with whom it was not used.

The researchers hypothesize that patients in the control group of the study will have statistically significant reductions in mean time spent in the emergency department, mean charges billed to the patient or their insurance carrier, hospital length of stay, mean number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chest pain represents the second most frequent complaint among the 110 million persons who visit emergency departments in the U.S. each year. Perceived medicolegal risk compels emergency physicians to overtest for possible acute coronary syndrome (ACS), contributing to more than $20 billion in unnecessary diagnostic testing each year. The hypothesis of the present work states that quantitative pretest probability assessment can significantly and safely increase the proportion of very low risk patients with symptoms of ACS who are discharged from one emergency department. Quantitative pretest probability will be assessed with the validated, commercially available PREtest Consult ACS software device, which employs computer assisted, attribute matching. This method matches an 8-component clinical profile from any individual patient to the same profile shared by patients who were previously evaluated for ACS and whose profiles are stored in a 14,800 patient reference database. Pretest probability estimates ≤ 2% will be considered "test negative." A phase II multicenter study found that when the ACS PREtest Consult produced a pretest probability of ACS ≤ 2.0% that the actual outcome of ACS at 45 days was 0.3% (95% CI 0 to 1.8%) compared with 0.4% (0 to 0.9%) for patients discharged after negative testing in a chest pain unit (CPU) that included serial biomarkers, overnight monitoring, and cardiologist-interpreted provocative testing. Over one-quarter of all patients referred to the CPU had an estimate ≤ 2%. The present study will randomize 400 ED patients with a non-diagnostic or normal ECG and a troponin test ordered into two groups:

  1. a "show me", or disclosure group, in which patients and their clinicians will receive the output of the device, and
  2. a "no show" or concealed group will receive no output.

The sample size will detect an 11.5% difference in rate of discharge between groups with α = 0.05 and β = 0.20. All discharged patients will undergo structured telephone and medical record follow-up at 7 and 45 days using validated methodology.

Primary outcome measures will evaluate the development of acute coronary syndrome.

Secondary variables will include:

  1. Frequency of ACS, determined by blinded adjudicated review of follow-up data,
  2. Rate of return to any ED for similar symptoms,
  3. Patient satisfaction,
  4. Charges.

Project significance includes the potential to reduce patient exposure to unnecessary invasive procedures and to save Medicare and other insurers over $100 million in unnecessary diagnostic testing each year in the U.S.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergency department patients aged > 17 who report a history of torso or arm discomfort within the past 24 hours.
  • Physician orders an electrocardiogram and serum troponin measurement.
  • Physician has undergone a 10 minute explanation session and has provided consent

Exclusion Criteria:

  • 12-lead electrocardiogram (ECG) with ST deviation or T-wave changes that are interpreted by clinician as indicative of acute infarction or ischemia
  • "Code STEMI" patients (patients with suspected acute myocardial infarction).
  • Other primary diagnosis mandating admission (e.g., pneumonia, diabetic ketoacidosis, trauma)
  • Patients with myocardial infarction, intracoronary stent placement, or coronary artery bypass grafting within the previous 30 days.
  • Evidence of circulatory shock (SBP [systolic blood pressure] < 100 mmHg with symptoms defined by Jones)
  • Cocaine use within the past 72 hours.
  • A moderate to high-risk composite clinical picture that causes an emergency medicine specialist to consult a cardiologist.
  • Homelessness, out-of-town residence or other condition known to preclude follow-up.
  • Prisoners and pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Documented myocardial infarction (ESC criteria)
Death thought to be from ACS (autopsy not required)
Need for revascularization (stent or surgical) within 45 days
Cardiac catheterization demonstrating

Secondary Outcome Measures

Outcome Measure
Percentage of patients deemed very low risk (pretest probability less than 2%) by the physician or the PREtest Consult ACS platform during the index visit
Percentage of patients discharged without admission to the hospital or emergency department chest pain unit during the index visit
Length of stay for the index visit to the emergency department
Incidence of stress testing, cardiac imaging and cardiac catheterization during the index visit and in the 45 days following the index visit
Hospital charges billed to each patient or their insurance provider for the index visit
Rate of reimbursement to the hospital for the index visit of each patient
Patient satisfaction as recorded by a survey instrument during a phone interview seven (7) days post-index visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PREtest Consult

Investigators

  • Principal Investigator: Jeffrey A Kline, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

October 1, 2007

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Estimate)

November 9, 2007

Last Update Submitted That Met QC Criteria

November 8, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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