Outpatient vs Hospital Evaluation for Chest Pain

(CARE-CP Trial)

Recruiting at 2 trial locations

Overseen By Lauren Victory

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Stemi, Pregnancy, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

502 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether managing moderate-risk chest pain patients in the hospital (Hospitalization Evaluation) or through a quick outpatient follow-up (Outpatient Evaluation) is more effective after discharge from the emergency room. Participants will be randomly assigned to either stay in the hospital for evaluation or go home and return for a rapid outpatient check-up within 72 hours. Ideal candidates for this trial are individuals who have experienced chest pain but have not had heart attacks or certain heart procedures and show moderate risk of acute coronary syndrome, a condition where blood flow to the heart is reduced. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future patient care strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that these evaluation strategies are safe for patients with chest pain?

Research shows that quickly evaluating chest pain in an outpatient setting can be safe for patients. Moderate-risk patients, in particular, have been managed safely without hospital admission. These patients typically need a follow-up with a doctor within 72 hours after leaving the emergency room. Studies suggest this method can be effective without increasing health risks, making outpatient evaluations a viable option for those not requiring immediate hospitalization.

Specific safety data for hospital evaluations is lacking because they are standard practice. However, hospital stays have been a common method to monitor chest pain patients, ensuring their safety through close observation and treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to evaluating chest pain: hospitalization evaluation and outpatient evaluation. Unlike the standard practice, which often involves keeping patients in the hospital for observation, the outpatient evaluation method allows patients to be discharged and receive follow-up care within 72 hours. This approach could potentially reduce healthcare costs and improve patient comfort by minimizing unnecessary hospital stays. Additionally, it emphasizes timely outpatient care focused on managing cardiovascular risk factors, which might enhance overall patient outcomes. This trial could lead to more efficient and patient-friendly strategies for managing chest pain.

What evidence suggests that this trial's evaluations could be effective for chest pain?

This trial compares two approaches for evaluating chest pain in patients with a moderate risk of heart problems. Participants in the "Outpatient Evaluation" arm will be discharged and receive outpatient evaluation, or cardiovascular ambulatory rapid evaluation (CARE), focusing on medical management for cardiovascular risk factors within 72 hours of Emergency Department discharge. Research has shown that this approach can be safe, with about 35% of patients managing their condition effectively at home. The goal is to keep patients stable and help them avoid unnecessary hospital stays. Meanwhile, participants in the "Hospitalization Evaluation" arm will receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding. Guidelines support this method, recommending risk assessment before deciding on the necessary care. ^{1 2 4 6 7}

Who Is on the Research Team?

Simon Mahler, MD, MS

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 21 with chest pain or symptoms suggesting a moderate risk of acute coronary syndrome, but without severe heart conditions like prior heart attacks or major artery blockages. They must have normal troponin levels and no other serious health issues that require hospitalization.

Inclusion Criteria

My heart's arteries are not 70% or more blocked.

I am 21 years old or older.

I am experiencing chest pain or symptoms similar to a heart attack.

Exclusion Criteria

You have significant changes in your ECG, like new T-wave inversions or ST changes of 1mm or more.

I have been diagnosed with a severe type of heart attack.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Randomization and Initial Evaluation

Participants are randomized to either outpatient evaluation (CARE-CP) or hospitalization evaluation for their symptoms.

72 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial evaluation, with focus on medical management for cardiovascular risk factors.

30 days

2 visits (in-person or virtual)

Long-term Follow-up

Participants are monitored for cardiovascular rehospitalizations and other outcomes at 1 year post-randomization.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Hospitalization Evaluation
• Outpatient Evaluation

Trial Overview The CARE-CP study is testing whether it's better to evaluate patients with acute chest pain through rapid outpatient care or traditional hospitalization. Participants are randomly assigned to one of these two approaches in the emergency department.

How Is the Trial Designed?

Group I: Outpatient Evaluation Experimental Treatment 1 Intervention

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.

Group II: Hospitalization Evaluation Experimental Treatment 1 Intervention

Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.

Hospitalization Evaluation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hospitalization Evaluation for:

• Acute Chest Pain
• Suspected Acute Coronary Syndrome (ACS)

Approved in European Union as Hospital Admission for:

• Acute Chest Pain
• Suspected ACS
• Cardiovascular Emergencies

Approved in Canada as Inpatient Evaluation for:

• Acute Chest Pain
• Suspected ACS
• Cardiac Conditions Requiring Monitoring

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

Implementing a dedicated chest pain emergency department (ED) could lead to increased healthcare costs ranging from $389 million to $3.9 billion, with a potential to save only 1,029 additional lives per year, making it a costly intervention at $378,000 to $3.78 million per life saved.

The study suggests that the current hospital-based evaluation systems for chest pain need improvement rather than complete replacement, advocating for an evolutionary change rather than the establishment of new chest pain EDs, which may not be an efficient use of resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The chest pain emergency department and the outpatient chest pain evaluation center: revolution or evolution? Shesser, R., Smith, M.[2019]

A stand-alone chest pain evaluation center (CPEC) effectively assessed 181 patients in its first 6 weeks, with 88% being discharged home, indicating a successful protocol for managing low-to-intermediate risk patients without acute coronary syndrome.

The establishment of the CPEC led to a significant reduction in hospital admissions for chest pain evaluations, dropping from 53% to 42% over two years, while the number of evaluations increased by 66%, demonstrating improved efficiency in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a stand-alone chest pain evaluation center within an academic emergency department. Winchester, DE., Stomp, D., Shifrin, RY., et al.[2021]

The Brief PREPARED (B-PREPARED) instrument, tested in a study of 460 patients, effectively measures how prepared patients feel for discharge from the hospital, showing good internal consistency and predictive validity.

Higher scores on the B-PREPARED scale correlate with better satisfaction regarding medication information and predict fewer emergency department visits after discharge, indicating its potential usefulness in improving discharge processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief scale measuring patient preparedness for hospital discharge to home: Psychometric properties. Graumlich, JF., Novotny, NL., Aldag, JC.[2015]

The Modified Physician-PREPARED scale was validated as a reliable tool to measure outpatient physicians' perceptions of hospital discharge quality, based on a survey of 403 patients and a 76% response rate.

Higher scores on the scale were associated with better discharge planning and communication, particularly when outpatient physicians were involved in the discharge process and aware of community support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discharge planning scale: community physicians' perspective. Graumlich, JF., Grimmer-Somers, K., Aldag, JC.[2015]

In a study of 322 patients presenting with chest pain in the emergency department, 3.7% experienced adverse cardiac events within 60 days after being discharged, highlighting the need for careful evaluation before discharge.

Despite a low rate of adverse events, 39.1% of patients followed up with a cardiologist, indicating ongoing concern and the importance of post-discharge monitoring for patients with chest pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of chest pain patients discharged from a French emergency department: a 60-day prospective study. Montassier, E., Batard, E., Gueffet, JP., et al.[2019]

In a study of 817 intermediate-risk chest pain patients referred to rapid access clinics, only 9.3% experienced major adverse coronary events (MACE) within 6 weeks, indicating that outpatient management is a safe option for these patients.

The most predictive factors for MACE were elevated troponin levels and patient history, suggesting that careful assessment of these components can help identify patients who may need closer monitoring or intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can ED chest pain patients with intermediate HEART scores be managed as outpatients? Moustapha, A., Mah, AC., Roberts, L., et al.[2022]

The implementation of a standardized chest pain protocol for intermediate risk patients at Advocate Christ Medical Center showed a trend towards reduced costs per discharge, with the protocol group averaging $830 less than the control group, although this difference was not statistically significant.

While the length of stay for patients in the protocol group was lower than in the control group, the difference was also not statistically significant, likely due to the small sample size of only 30 patients analyzed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Chest Pain Protocol Targeting Intermediate Cardiac Risk Patients in an Observation Unit of an Academic Tertiary Care Center. Yousuf, T., Keshmiri, H., Ziffra, J., et al.[2020]

A study involving 3081 patients found that same-day discharge after percutaneous coronary interventions (PCI) did not lead to significantly different adverse cardiovascular outcomes compared to an overnight hospital stay, indicating that same-day discharge is a safe option for patients with stable coronary artery disease (CAD).

Key outcomes such as mortality, myocardial infarction, and major adverse cardiac events were similar between the two groups, suggesting that patients can be safely discharged on the same day without increased risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same Day Discharge versus Overnight Stay in the Hospital following Percutaneous Coronary Intervention in Patients with Stable Coronary Artery Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Bundhun, PK., Soogund, MZ., Huang, WQ.[2018]

In a study of 157 emergency department patients with chest pain who had negative evaluations for acute coronary syndrome, 14% experienced adverse cardiac events within six months, highlighting a significant long-term risk after such evaluations.

Patients undergoing outpatient diagnostic tests had a significantly higher risk of adverse cardiac events compared to those tested inpatient, suggesting that inpatient testing may be more appropriate for patients at risk of noncompliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse cardiac events in emergency department patients with chest pain six months after a negative inpatient evaluation for acute coronary syndrome. Manini, AF., Gisondi, MA., van der Vlugt, TM., et al.[2019]

In a study of 38,778 emergency department patients evaluated for chest pain by 327 physicians, there was a significant variation in hospital admission rates, ranging from 1.5% to 68.9%, even after adjusting for patient characteristics.

Despite the differences in admission rates, there was no significant difference in the 30-day rates of death or acute myocardial infarction between patients treated by high-admitting and low-admitting physicians, indicating that higher admission rates do not necessarily lead to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Emergency Physician Chest Pain Hospitalization Rates Do Not Lead to Improved Patient Outcomes. Natsui, S., Sun, BC., Shen, E., et al.[2022]

A systematic review of 13 studies involving 111,830 patients suggests that same-day discharge (SDD) after percutaneous coronary intervention (PCI) is a reasonable option for selected patients, showing no significant increase in complications compared to overnight hospitalization (ON).

However, the results showed considerable variability across studies, indicating that more extensive and well-powered trials are needed to definitively assess the safety and efficacy of SDD versus ON after PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and meta-analysis. Abdelaal, E., Rao, SV., Gilchrist, IC., et al.[2022]

The study introduces the Composite Patient Encounter (CPE) as a new measure to accurately reflect hospital productivity by equating outpatient and inpatient care based on production costs.

CPE was derived from actual data and tested against other variables, showing it to be the most accurate statistic for representing overall hospital activity compared to previous measures that were limited or mixed in their approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What we do and how to measure it. Ford, RL.[2007]

Patients excluded from same-day discharge after percutaneous coronary intervention (PCI) had significantly higher rates of major adverse cardiac events, such as death and myocardial infarction, compared to those who were randomized for same-day discharge, with rates of 10.2% vs. 1.6% at 30 days.

Two specific angiographic criteria—transient vessel closure and residual dissection greater than grade B—were identified as independent predictors of worse outcomes, highlighting their importance in determining which patients should remain hospitalized after PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and late outcomes in patients excluded from same-day home discharge after transradial stenting and maximal antiplatelet therapy. Bertrand, OF., Rodés-Cabau, J., Larose, E., et al.[2016]

A study of 36 elective PCI patients showed that same-day discharge is safe, with only two minor in-hospital bleeding events and no adverse events reported within the first 24 hours.

The findings suggest that same-day discharge after PCI could enhance patient satisfaction and hospital efficiency, but further research is needed to confirm these benefits in larger, more diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Same-day discharge after elective coronary angioplasty: a single-center initial experience]. Capoferri, A., Degani, M., Ghedi, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11386260/

Rapid outpatient evaluation for emergency department ... This study aims to assess the safety of an outpatient chest pain pathway (OCPP) for patients presenting to the emergency department (ED) with chest pain and ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05897632/care-cp-testing-a-cardiovascular-ambulatory-rapid-evaluation-for-patients-with-chest-pain

CARE-CP (Testing a Cardiovascular Ambulatory Rapid ... The preliminary data suggest that moderate risk patients (35% of patients with chest pain) can be safely managed as outpatients using a ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/emp2.13280

Rapid outpatient evaluation for emergency department ... This study aims to assess the safety of an outpatient chest pain pathway (OCPP) for patients presenting to the emergency department (ED) with ...

4. aafp.org aafp.org/pubs/afp/issues/2020/1215/p721.html

Acute Chest Pain in Adults: Outpatient Evaluation Initial evaluation is based on determining whether the patient needs to be referred to a higher level of care to rule out acute coronary syndrome (ACS).

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001029

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR ... This guideline presents an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain.

6. annemergmed.com annemergmed.com/article/S0196-0644(19)30708-5/fulltext

32 Implementation of a Novel Rapid Cardiac Evaluation ... Chest pain (CP) accounts for 5.2% of emergency department cases, with an approximate treatment cost of $3,500pp (ED+CP/OBS stay). Although there are methods ...

7. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01HS029017&arg_ProgOfficeCode=7

Award Information | HHS TAGGS Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients with Chest Pain (CARE-CP). Award Number: R01HS029017. ORGANIZATION: AGENCY FOR HEALTH CARE ...