About this trial
The goal of this study is to determine if rapid outpatient evaluation vs hospitalization management is the best strategy (based on patient-centered measures and safe, equitable, and efficient resource use) for evaluating patients with acute chest pain who are at moderate risk for acute coronary syndrome (ACS). Patients will be randomized in the Emergency Department to either an outpatient evaluation (CARE-CP) or hospitalization evaluation for their symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥21 years old
Chest pain or Symptoms of acute coronary syndrome (ACS)
Moderate risk of ACS (all of the below)
Hear Score 4-6
Disqualifiers
ST Elevation Myocardial Infarction (STEMI) Activation
ST Changes or new T-wave inversions ≥1mm on ECG
Any Elevated Troponin Measure (Based on Sex-Specific 99th Percentile)
Serial change between Troponin Measures (Delta) ≥5 pg/mL
Trial design
Parallel
Treatments tested in this trial
Outpatient Evaluation
BehavioralSubjects will receive an outpatient evaluation within 72 of being discharged from the ED.
Hospitalization Evaluation
BehavioralPatients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.
Treatment groups
Trial outcomes
Primary outcomes
Hospital-free days (HFD) at 30-days post-randomization
Time spent in a hospital setting at 30 days post-randomization will be measured and subtracted from time spent outside the hospital. Hospital time is broadly defined, based on a patient-centered definition of cumulative time spent in the ED, observation unit, or hospital ward. Consistent with prior trials, patients who experience death during the follow-up period are assigned zero HFDs.
Secondary outcomes
Hospital-free days (HFD) at 1-year post-randomization
Time spent in a hospital setting at 1 year post-randomization will be measured and subtracted from time spent outside the hospital. Hospital time is broadly defined, based on a patient-centered definition of cumulative time spent in the ED, observation unit, or hospital ward. Consistent with prior trials, patients who experience death during the follow-up period are assigned zero HFDs.
Cardiovascular Hospital-free days (HFD) at 30-days post-randomization
Rates of cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.
Cardiovascular Hospital-free days (HFD) at 1 year post-randomization
Rates of cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.
Rate of noninvasive cardiac testing at 30-days post-randomization
The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 30-days post-randomization will be analyzed between the two treatment arms.
Sponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator