search
Back to results

CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain) (CARE-CP)

Primary Purpose

Chest Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient Evaluation
Hospitalization Evaluation
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring Acute Coronary Syndrome, Cardiovascular Diseases

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Hospital
  • Carolinas Medical Center
  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Outpatient Evaluation

Hospitalization Evaluation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.
Rate of noninvasive cardiac testing at 1 year post-randomization
The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 1 year post-randomization will be analyzed between the two treatment arms.
Rate of invasive cardiac testing at 30-days post-randomization
The rates of invasive testing (coronary angiography), at 30-days post-randomization will be analyzed between the two treatment arms.
Rate of invasive cardiac testing at 1 year post-randomization
The rates of invasive testing (coronary angiography), at 1 year post-randomization will be analyzed between the two treatment arms.
Cardiovascular repeat ED visits at 30-days post-randomization
The rates of Cardiovascular repeat ED visits at 30-days post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Cardiovascular repeat ED visits at 1 year post-randomization
The rates of Cardiovascular repeat ED visits at 1 year post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Cardiovascular rehospitalizations at 30-days post-randomization
The rates of Cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Cardiovascular rehospitalizations at 1 year post-randomization
The rates of Cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Patient satisfaction (SAPS questionnaire)
Satisfaction will be assessed using the Short Assessment of Patient Satisfaction (SAPS). A patient satisfaction survey will be sent that evaluates clinician communication, participation in medical decision-making, respect by the clinician, clinician carefulness, time with the clinician, and treatment effect, in any service setting on a five-point Likert scale from "very dissatisfied" to "very satisfied". Scores from each item are summed and range from 0 (extremely dissatisfied) to 28 (extremely satisfied).
Patient experience (GS-PEQ instrument)
Experience will be measured using the Generic Short Patient Experience Questionnaire (GS-PEQ). A patient experience survey will also be sent out to evaluate which assesses timeliness and organization of medical services, confidence in the clinician and treatment, patient involvement in decision-making, clinician communication, patient outcomes, and incorrect treatment on a 5-point Likert-scale from "not at all" to "to a very large extent" and one question (on wait times) scored on a 4-point Likert scale from "no" to "yes, way too long. A mean score can be calculated for each patient, with higher scores indicating better experience.
Out-of-pocket cost (based on billing data)
Patient satisfaction, patient experience, and out-of-pocket costs will be measured in all trial participants. Financial records will be utilized from each site to determine patient billing, including the amount covered by insurance vs. patient responsibility. Each item will be measured in U.S. dollars and summed for total cost.
Drivers of Patient Satisfaction and Experience (Qualitative)
A subset of 100 patients (50 from each arm) will be purposively selected to ensure diversity in sex, race, ethnicity, socioeconomic status (SES), and health literacy for 30-minute semi-structured phone interviews to determine key drivers of patient satisfaction and experience. We will use an explanatory sequential mixed-methods design, in which participants' quantitative data will guide the collection and analysis of their qualitative data.These data will provide key context and meaning to the patient's quantitative response regarding patient satisfaction, experience, and out-of-pocket cost.

Full Information

First Posted
June 1, 2023
Last Updated
October 13, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
search

1. Study Identification

Unique Protocol Identification Number
NCT05897632
Brief Title
CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
Acronym
CARE-CP
Official Title
CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain )
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Acute Coronary Syndrome, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized with equal probability (1:1) to the outpatient arm or the hospitalization arms using permuted block randomization.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Evaluation
Arm Type
Other
Arm Description
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.
Arm Title
Hospitalization Evaluation
Arm Type
Other
Arm Description
Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.
Intervention Type
Behavioral
Intervention Name(s)
Outpatient Evaluation
Other Intervention Name(s)
CARE-CP (Cardiovascular Ambulatory Rapid Evaluation)
Intervention Description
Subjects will receive an outpatient evaluation within 72 of being discharged from the ED.
Intervention Type
Behavioral
Intervention Name(s)
Hospitalization Evaluation
Intervention Description
Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.
Primary Outcome Measure Information:
Title
Hospital-free days (HFD) at 30-days post-randomization
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Hospital-free days (HFD) at 1-year post-randomization
Description
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.
Time Frame
Year 1
Title
Cardiovascular Hospital-free days (HFD) at 30-days post-randomization
Description
Rates of cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.
Time Frame
Day 30
Title
Cardiovascular Hospital-free days (HFD) at 1 year post-randomization
Description
Rates of cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.
Time Frame
Year 1
Title
Rate of noninvasive cardiac testing at 30-days post-randomization
Description
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.
Time Frame
Day 30
Title
Rate of noninvasive cardiac testing at 1 year post-randomization
Description
The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 1 year post-randomization will be analyzed between the two treatment arms.
Time Frame
Year 1
Title
Rate of invasive cardiac testing at 30-days post-randomization
Description
The rates of invasive testing (coronary angiography), at 30-days post-randomization will be analyzed between the two treatment arms.
Time Frame
Day 30
Title
Rate of invasive cardiac testing at 1 year post-randomization
Description
The rates of invasive testing (coronary angiography), at 1 year post-randomization will be analyzed between the two treatment arms.
Time Frame
Year 1
Title
Cardiovascular repeat ED visits at 30-days post-randomization
Description
The rates of Cardiovascular repeat ED visits at 30-days post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Time Frame
Day 30
Title
Cardiovascular repeat ED visits at 1 year post-randomization
Description
The rates of Cardiovascular repeat ED visits at 1 year post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Time Frame
Year 1
Title
Cardiovascular rehospitalizations at 30-days post-randomization
Description
The rates of Cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Time Frame
Day 30
Title
Cardiovascular rehospitalizations at 1 year post-randomization
Description
The rates of Cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Time Frame
Year 1
Title
Patient satisfaction (SAPS questionnaire)
Description
Satisfaction will be assessed using the Short Assessment of Patient Satisfaction (SAPS). A patient satisfaction survey will be sent that evaluates clinician communication, participation in medical decision-making, respect by the clinician, clinician carefulness, time with the clinician, and treatment effect, in any service setting on a five-point Likert scale from "very dissatisfied" to "very satisfied". Scores from each item are summed and range from 0 (extremely dissatisfied) to 28 (extremely satisfied).
Time Frame
Day 30
Title
Patient experience (GS-PEQ instrument)
Description
Experience will be measured using the Generic Short Patient Experience Questionnaire (GS-PEQ). A patient experience survey will also be sent out to evaluate which assesses timeliness and organization of medical services, confidence in the clinician and treatment, patient involvement in decision-making, clinician communication, patient outcomes, and incorrect treatment on a 5-point Likert-scale from "not at all" to "to a very large extent" and one question (on wait times) scored on a 4-point Likert scale from "no" to "yes, way too long. A mean score can be calculated for each patient, with higher scores indicating better experience.
Time Frame
Day 30
Title
Out-of-pocket cost (based on billing data)
Description
Patient satisfaction, patient experience, and out-of-pocket costs will be measured in all trial participants. Financial records will be utilized from each site to determine patient billing, including the amount covered by insurance vs. patient responsibility. Each item will be measured in U.S. dollars and summed for total cost.
Time Frame
Day 30
Title
Drivers of Patient Satisfaction and Experience (Qualitative)
Description
A subset of 100 patients (50 from each arm) will be purposively selected to ensure diversity in sex, race, ethnicity, socioeconomic status (SES), and health literacy for 30-minute semi-structured phone interviews to determine key drivers of patient satisfaction and experience. We will use an explanatory sequential mixed-methods design, in which participants' quantitative data will guide the collection and analysis of their qualitative data.These data will provide key context and meaning to the patient's quantitative response regarding patient satisfaction, experience, and out-of-pocket cost.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Koehler
Phone
336-716-4646
Email
lekoehle@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Victory
Phone
336-716-7260
Email
lvictory@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Mahler, MD, MS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Koehler

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)

We'll reach out to this number within 24 hrs