Chest Pain, Myocardial Ischemia
Conditions
Keywords
high-sensitivity troponin, chest pain
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
Interventions
OTHERRACE-IT Pathway
This care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score
OTHERStandard of Care
Standard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score
Sponsors
Beckman Coulter, Inc.
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped-Wedge Cluster Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy 2. Any ED-drawn hs-cTnI value \> 99th percentile (18 ng/L) 3. Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident) 4. A transfer from another facility 5. Primary residence outside the state of Michigan 6. Previous inclusion in the study 7. Enrolled in hospice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safe ED discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit |
| Number of participants with death or acute myocardial infarction | 30-day and through 1 year | Death or presence of acute myocardial infarction determined by adjudication panel |
| Composite number of cardiology resources utilized | 30-days | Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention |
| Hospital payments received | 30-days | The total hospital payments received for the initial ED visit and any subsequent hospitalizations and procedures that are cardiology related over 30-days from the initial encounter. |
| Number of participants with revascularization or rehospitalization for cardiovascular disease | 30-days | revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pre-specified sub-group analyses of the primary outcome | 30 days | We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge |
Countries
United States
Outcome results
None listed