Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chest Pain
- Sponsor
- Henry Ford Health System
- Enrollment
- 32609
- Locations
- 1
- Primary Endpoint
- Safe ED discharge
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).
Detailed Description
This is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new protocol is executed across 9 EDs within an integrated health system, the investigators will study its effects on patient and system-level metrics. A modified stepped wedge design will be utilized that allows comparison of the RACE-IT pathway with standard of care management
Investigators
Joseph Miller, MD
Principal Investigator
Henry Ford Health System
Eligibility Criteria
Inclusion Criteria
- •Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.
Exclusion Criteria
- •ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
- •Any ED-drawn hs-cTnI value \> 99th percentile (18 ng/L)
- •Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
- •A transfer from another facility
- •Primary residence outside the state of Michigan
- •Previous inclusion in the study
- •Enrolled in hospice
Outcomes
Primary Outcomes
Safe ED discharge
Time Frame: 30 days after initial presentation
Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
Secondary Outcomes
- Number of participants with revascularization or rehospitalization for cardiovascular disease(30-days)
- Number of participants with death or acute myocardial infarction(30-day and through 1 year)
- Length of hospital stay(From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.)
- Composite number of cardiology resources utilized(30-days)
- Hospital payments received(30-days)