Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243516
Status:
UNKNOWN
Last Update Posted:
2007-11-09
First Post:
2005-10-17
Brief Title:
Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain
Sponsor:
PREtest Consult
Organization:
PREtest Consult
Study Overview
Official Title:
Randomized Controlled Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 20 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
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
Detailed Description:
Chest pain represents the second most frequent complaint among the 110 million persons who visit emergency departments in the US 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 14800 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 20 that the actual outcome of ACS at 45 days was 03 95 CI 0 to 18 compared with 04 0 to 09 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 115 difference in rate of discharge between groups with α 005 and β 020 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 US
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 115 difference in rate of discharge between groups with α 005 and β 020 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 US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None