Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
| Status: | Completed |
|---|---|
| Conditions: | Angina, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 8/16/2018 |
| Start Date: | September 2012 |
| End Date: | January 15, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
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