Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05897632
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-06-01
Brief Title:
CARE-CP Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
CARE-CP Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE-CP
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 eg 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 11 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 US and beyond
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None