Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain (HEART Pathway)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome Chest Pain |
Other: HEART Pathway |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain |
- Objective cardiac testing (stress testing or cardiac imaging) within 30 days [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Rate of objective cardiac testing within 30 days
- Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Index objective cardiac testing rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ] [ Designated as safety issue: No ]proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
- Index Hospital Admission Rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ] [ Designated as safety issue: No ]Proportion of patients hospitalized for admission or observation during the index visit
- Early discharge rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ] [ Designated as safety issue: No ]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 [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
- Major adverse cardiac events (MACE) [ Time Frame: 30 Days and 1 Year ] [ Designated as safety issue: Yes ]
- Missed MACE [ Time Frame: 30 Days and 1 Year ] [ Designated as safety issue: Yes ]MACE occurring in patients discharged without objective cardiac testing.
- Provider adherence to the HEART Pathway [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ] [ Designated as safety issue: No ]
- Inter-rater reliability of the HEART Pathway [ Time Frame: Duration of the Index ED visit, less than 1 day ] [ Designated as safety issue: No ]
| Enrollment: | 282 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | January 2016 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HEART Pathway
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.
|
Other: HEART Pathway
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
|
|
No Intervention: Usual Care
Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01665521
| United States, North Carolina | |
| Wake Forest Wake Forest University Baptist Medical Center - Emergency Department | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Simon A Mahler, MD | Wake Forest Baptist Health |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Simon Mahler, MD, Associate Professor, Wake Forest Baptist Health |
| ClinicalTrials.gov Identifier: | NCT01665521 History of Changes |
| Other Study ID Numbers: | 12CRP12000001 IRB00021074 |
| Study First Received: | August 7, 2012 |
| Last Updated: | December 8, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest Baptist Health:
|
Acute Coronary Syndrome Chest pain Risk Stratification HEART Pathway Emergency Department |
Additional relevant MeSH terms:
|
Emergencies Acute Coronary Syndrome Chest Pain Disease Attributes Pathologic Processes Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 26, 2016