Clinical trial NCT05897632: CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
Official title: CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain )
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
Keywords: Acute Coronary Syndrome
Cardiovascular Diseases
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-06-09
Enrollment: 502
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized with equal probability (1:1) to the outpatient arm or the hospitalization arms using permuted block randomization.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Current care patterns for the 7 million patients visiting Emergency Departments (EDs) in the United States with chest pain are heterogeneous and not sustainable from a healthcare quality or economic perspective. Chest pain is the second most common cause of ED visits and the most common reason for short-stay hospitalizations. During these hospitalizations patients undergo in-depth evaluations (stress testing, computed tomography coronary angiography, or invasive angiography), but ultimately \<10% are diagnosed with acute coronary syndrome (ACS). These evaluations cost $3 billion annually and strain health system resources without clear evidence of improved health outcomes or patient experience. The preliminary data suggest that moderate risk patients (35% of patients with chest pain) can be safely managed as outpatients using a cardiovascular ambulatory rapid evaluation (CARE-CP) strategy as an alternative to hospitalization. In the CARE-CP strategy, patients are discharged from the ED and receive outpatient clinic follow-up within 72 hours focused on medical management for cardiovascular risk factors (e.g., hypertension, diabetes) and determining whether further cardiac testing is needed. This strategy aims to enhance patient-centered outcomes while safely and equitably decreasing hospital resource utilization. However, equipoise exists between outpatient and hospitalization strategies for moderate risk patients. There is a paucity of prospective data evaluating the efficacy and patient-centeredness of outpatient chest pain evaluation strategies in moderate risk patients. Thus, it is unclear whether use of an outpatient chest pain management strategy (CARE-CP) will safely reduce healthcare utilization and be preferred by patients compared to a traditional hospitalization strategy. To address this key evidence gap, the study proposes the first prospective multisite randomized trial testing outpatient vs hospitalization strategies in moderate risk patients. The research teams will randomize 502 patients 1:1 to the CARE-CP or hospitalization management arms at three ED sites with a history of high recruitment rates and productive collaborations in cardiovascular clinical trials. The primary outcome will be hospital-free days (HFD) over a 30-day period. This novel trial addresses a key evidence gap by providing guidance on how best to evaluate moderate risk ED patients with acute chest pain. Without this guidance care patterns are likely to remain heterogeneous, inefficient, non-patient-centered, and unguided by the highest level of evidence. We hypothesize that data from this trial will support widespread implementation of a CARE-CP strategy, which could improve the quality and value of care for millions of patients in the U.S. and beyond.

Eligibility criteria: Inclusion Criteria:

* 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
* Non-Ischemic electrocardiogram (ECG)
* Two Troponin measures \< Sex-Specific Upper Reference Limit

  * Women \<15 pg/ml
  * Men \<20 pg/ml
* No prior coronary artery disease (CAD)

  * No Prior Myocardial Infarction (MI)
  * No Prior Coronary Revascularization Procedures
  * No Patients with ≥ 70% Obstructive Coronary Disease

Exclusion Criteria:

* 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
* Stress Echocardiography, Nuclear Stress Test, Stress ECG, Stress Cardiac MRI, Coronary CT Angiogram (CCTA), Invasive Coronary Angiography (Cardiac Cath) within 1 year
* "Clean" CCTA or Cardiac Cath (0% stenosis in all vessels) within the past 2 years
* Chest Trauma
* Pregnancy
* Life Expectancy \< 1 year
* Other comorbid conditions requiring hospitalization
* Unstable Vitals (Blood Pressure \<90, Heart Rate \>120 or \<50, O2 Sat \<90%)
* End Stage Renal Disease; Dialysis or estimated glomerular filtration rate (eGFR) \<30 mL/min
* Transfers From Another Hospital
* Non-English Speaking
* Prisoners
* Prior Enrollment
* Already Enrolled in Other Interventional Trial

Primary outcomes:
measure: Hospital-free days (HFD) at 30-days post-randomization
timeFrame: Day 30
Secondary outcomes:
measure: Hospital-free days (HFD) at 1-year post-randomization
timeFrame: Year 1
measure: Cardiovascular Hospital-free days (HFD) at 30-days post-randomization
timeFrame: Day 30
measure: Cardiovascular Hospital-free days (HFD) at 1 year post-randomization
timeFrame: Year 1
measure: Rate of noninvasive cardiac testing at 30-days post-randomization
timeFrame: Day 30
measure: Rate of noninvasive cardiac testing at 1 year post-randomization
timeFrame: Year 1
measure: Rate of invasive cardiac testing at 30-days post-randomization
timeFrame: Day 30
measure: Rate of invasive cardiac testing at 1 year post-randomization
timeFrame: Year 1
measure: Cardiovascular repeat ED visits at 30-days post-randomization
timeFrame: Day 30
measure: Cardiovascular repeat ED visits at 1 year post-randomization
timeFrame: Year 1
measure: Cardiovascular rehospitalizations at 30-days post-randomization
timeFrame: Day 30
measure: Cardiovascular rehospitalizations at 1 year post-randomization
timeFrame: Year 1
measure: Patient satisfaction (SAPS questionnaire)
timeFrame: Day 30
measure: Patient experience (GS-PEQ instrument)
timeFrame: Day 30
measure: Out-of-pocket cost (based on billing data)
timeFrame: Day 30
measure: Drivers of Patient Satisfaction and Experience (Qualitative)
timeFrame: Day 30
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Simon Mahler, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: