Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain
|ClinicalTrials.gov Identifier: NCT00243516|
Recruitment Status : Unknown
Verified September 2006 by PREtest Consult.
Recruitment status was: Recruiting
First Posted : October 24, 2005
Last Update Posted : November 9, 2007
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 or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Device: PREtest Consult||Phase 3|
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:
- a "show me", or disclosure group, in which patients and their clinicians will receive the output of the device, and
- 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:
- Frequency of ACS, determined by blinded adjudicated review of follow-up data,
- Rate of return to any ED for similar symptoms,
- Patient satisfaction,
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Controlled Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain|
|Study Start Date :||October 2005|
|Estimated Study Completion Date :||October 2007|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243516
|Contact: William B Webb, BSPHemail@example.com|
|Contact: Jane A Kilkenny, BAfirstname.lastname@example.org|
|United States, North Carolina|
|Carolinas Medical Center||Recruiting|
|Charlotte, North Carolina, United States, 28203|
|Contact: Jane A Kilkenny, BA 704-355-3975 email@example.com|
|Contact: William B Webb, BSPH 704-355-0602 firstname.lastname@example.org|
|Principal Investigator: Jeffrey A Kline, MD|
|Principal Investigator:||Jeffrey A Kline, MD||Carolinas Healthcare System|