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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by PREtest Consult.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
PREtest Consult
ClinicalTrials.gov Identifier:
NCT00243516
First received: October 17, 2005
Last updated: November 8, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Device: PREtest Consult
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized, Controlled Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain

Resource links provided by NLM:


Further study details as provided by PREtest Consult:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 400
Study Start Date: October 2005
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243516

Contacts
Contact: William B Webb, BSPH 704-355-0602 bwebb@pretestconsult.com
Contact: Jane A Kilkenny, BA 704-355-3975 jane.kilkenny@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jane A Kilkenny, BA    704-355-3975    jane.kilkenny@carolinashealthcare.org   
Contact: William B Webb, BSPH    704-355-0602    bwebb@pretestconsult.com   
Principal Investigator: Jeffrey A Kline, MD         
Sponsors and Collaborators
PREtest Consult
Investigators
Principal Investigator: Jeffrey A Kline, MD Carolinas Healthcare System
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00243516     History of Changes
Other Study ID Numbers: 1
Study First Received: October 17, 2005
Last Updated: November 8, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by PREtest Consult:
Acute Coronary Syndrome
Emergency Department
Chest Pain Evaluation Unit
Overtesting
Chest Pain Protocol
Myocardial Infarction
Medical Malpractice

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Syndrome
Angina Pectoris
Cardiovascular Diseases
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014