CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain )
概览
- 阶段
- 不适用
- 干预措施
- Hospitalization Evaluation
- 疾病 / 适应症
- Chest Pain
- 发起方
- Wake Forest University Health Sciences
- 入组人数
- 502
- 试验地点
- 5
- 主要终点
- Hospital-free days (HFD) at 30-days post-randomization
- 状态
- 招募中
- 最后更新
- 26天前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Hospitalization Evaluation
Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.
干预措施: Hospitalization Evaluation
Outpatient Evaluation
Patients randomized to this arm are discharged and receive outpatient evaluation, or cardiovascular ambulatory rapid evaluation (CARE), focused on medical management for cardiovascular risk factors (e.g. hypertension) within 72 hours of Emergency Department discharge.
干预措施: Outpatient Evaluation
结局指标
主要结局
Hospital-free days (HFD) at 30-days post-randomization
时间窗: Day 30
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.
次要结局
- Cardiovascular Hospital-free days (HFD) at 1 year post-randomization(Year 1)
- Out-of-pocket cost (based on billing data)(Day 30)
- Rate of invasive cardiac testing at 1 year post-randomization(Year 1)
- Cardiovascular repeat ED visits at 30-days post-randomization(Day 30)
- Patient satisfaction (SAPS questionnaire)(Day 30)
- Cardiovascular repeat ED visits at 1 year post-randomization(Year 1)
- Cardiovascular rehospitalizations at 30-days post-randomization(Day 30)
- Cardiovascular rehospitalizations at 1 year post-randomization(Year 1)
- Patient experience (GS-PEQ instrument)(Day 30)
- Hospital-free days (HFD) at 1-year post-randomization(Year 1)
- Cardiovascular Hospital-free days (HFD) at 30-days post-randomization(Day 30)
- Rate of noninvasive cardiac testing at 30-days post-randomization(Day 30)
- Rate of noninvasive cardiac testing at 1 year post-randomization(Year 1)
- Rate of invasive cardiac testing at 30-days post-randomization(Day 30)
- Drivers of Patient Satisfaction and Experience (Qualitative)(Day 30)