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Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain (HEART Pathway)

Primary Purpose

Acute Coronary Syndrome, Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEART Pathway
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Chest pain, Risk Stratification, HEART Pathway, Emergency Department

Eligibility Criteria

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

Inclusion Criteria:

  • Age greater than or equal to 21 years
  • Chest discomfort or other symptoms consistent with possible ACS
  • The treating physician feels the patient could be discharged home if cardiac disease was excluded

Exclusion Criteria:

  • New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV)
  • Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate)
  • Terminal diagnosis with life expectancy less than 1 year
  • A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing.
  • Prior enrollment
  • Incapacity or unwillingness to provide consent and comply with study procedures
  • Non-English speaking

Sub-study I & II

Inclusion Criteria:

  • ED attending physicians

Exclusion Criteria:

  • ED attending physicians who decline to participate

Sites / Locations

  • Wake Forest Wake Forest University Baptist Medical Center - Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HEART Pathway

Usual Care

Arm Description

The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing.

Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.

Outcomes

Primary Outcome Measures

Objective cardiac testing (stress testing or cardiac imaging) within 30 days
Rate of objective cardiac testing within 30 days

Secondary Outcome Measures

Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.
Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain.
Index objective cardiac testing rate
proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
Index Hospital Admission Rate
Proportion of patients hospitalized for admission or observation during the index visit
Early discharge rate
Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing
Composite of 30 day hospital admission and objective cardiac testing

Full Information

First Posted
August 7, 2012
Last Updated
March 3, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01665521
Brief Title
Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
Acronym
HEART Pathway
Official Title
Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
February 20, 2016 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
American Heart Association

4. Oversight

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

5. Study Description

Brief Summary
Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.
Detailed Description
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. The total cost of chest pain evaluations has been estimated at $5-10 billion annually, yet only 10% of these patients are ultimately diagnosed with an acute coronary syndrome. American College of Cardiology/ American Heart Association (ACC/AHA) guidelines recommend that patients at low-risk for acute coronary syndrome should receive serial cardiac markers followed by objective cardiac testing (stress testing or cardiac imaging). However, many have questioned the value of objective cardiac testing in all low-risk patients.Cardiac testing for all patients at low-risk for acute coronary syndrome (ACS) is not sustainable from a healthcare quality or economic perspective. In addition to increasing costs, objective cardiac testing is associated with a substantial number of false positive and non-diagnostic tests, which lead to additional unnecessary and often invasive procedures. Implementation of accurate risk stratification care pathways designed to eliminate unnecessary cardiac testing could improve the efficiency and quality of care by decreasing false positive/non-diagnostic testing, radiation, and costs. The HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, is a recently developed care pathway designed to identify chest pain patients for early discharge without objective testing. Primary Hypothesis: The HEART Pathway, when compared to usual care, will reduce 30 day objective cardiac testing, hospital length of stay, and cost, while maintaining patient safety. Methods: Participants (n=282) at risk for ACS will be recruited into a clinical trial from Wake Forest Baptist Medical Center (WFBMC) ED. Patients will be equally randomized to HEART Pathway or Usual Care. HEART Pathway participant's treating physician will follow HEART Pathway guidelines for identifying patients to be admitted to the hospital or observation unit for cardiac testing or to be discharged home without testing. Usual Care participant's treating physicians will decide whether the patients should be discharged home or admitted to the hospital or observation unit based on ACC/AHA guidelines without using the HEART pathway.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Chest Pain
Keywords
Acute Coronary Syndrome, Chest pain, Risk Stratification, HEART Pathway, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEART Pathway
Arm Type
Experimental
Arm Description
The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.
Intervention Type
Other
Intervention Name(s)
HEART Pathway
Intervention Description
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
Primary Outcome Measure Information:
Title
Objective cardiac testing (stress testing or cardiac imaging) within 30 days
Description
Rate of objective cardiac testing within 30 days
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.
Time Frame
30 Days
Title
Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain.
Time Frame
1 Year
Title
Index objective cardiac testing rate
Description
proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
Time Frame
Duration of Index Hospitalization, average of 1 to 2 days
Title
Index Hospital Admission Rate
Description
Proportion of patients hospitalized for admission or observation during the index visit
Time Frame
Duration of Index Hospitalization, average of 1 to 2 days
Title
Early discharge rate
Description
Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing
Time Frame
Duration of Index Hospitalization, average of 1 to 2 days
Title
Composite of 30 day hospital admission and objective cardiac testing
Time Frame
30 Days
Other Pre-specified Outcome Measures:
Title
Major adverse cardiac events (MACE)
Time Frame
30 Days and 1 Year
Title
Missed MACE
Description
MACE occurring in patients discharged without objective cardiac testing.
Time Frame
30 Days and 1 Year
Title
Provider adherence to the HEART Pathway
Time Frame
Duration of Index Hospitalization, average of 1 to 2 days
Title
Inter-rater reliability of the HEART Pathway
Time Frame
Duration of the Index ED visit, less than 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 21 years Chest discomfort or other symptoms consistent with possible ACS The treating physician feels the patient could be discharged home if cardiac disease was excluded Exclusion Criteria: New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV) Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate) Terminal diagnosis with life expectancy less than 1 year A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing. Prior enrollment Incapacity or unwillingness to provide consent and comply with study procedures Non-English speaking Sub-study I & II Inclusion Criteria: ED attending physicians Exclusion Criteria: ED attending physicians who decline to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon A Mahler, MD
Organizational Affiliation
Wake Forest Baptist Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Wake Forest University Baptist Medical Center - Emergency Department
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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URL
http://www.wakehealth.edu
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Wake Forest Baptist Health

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Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

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