Clinical trial NCT02056964: HEART Pathway Implementation
Official title: The HEART Pathway: Bridging the Gap Between Operations, Research, and Education
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Acute Coronary Syndrome
Chest Pain Atypical Syndrome
Chest Pain Rule Out Myocardial Infarction
Keywords: Acute Coronary Syndrome
Chest Pain
Risk Stratification
Clinical Decision Aid
Emergency Department
Low Risk Chest Pain
Non Cardiac Chest Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Association of American Medical Colleges
name: Donaghue Medical Research Foundation
First posted: 2014-02-06
Enrollment: 14717
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population is adult patients with acute chest pain, but without obvious Acute Coronary Syndrome (ACS) on Electrocardiogram (ECG). Therefore, adult patients (\>21 years old) with acute chest pain, for whom the provider orders troponins, and without evidence of an ST-segment elevation myocardial infarction (STEMI) on ECG, will be included. Based on STEMI rates at Wake Forest Baptist Medical Center (WFBMC) we expect less than 5% of patients with acute chest pain to be excluded due to ECG criteria.

Brief summary: The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical decision aid for the care of patients with chest pain, in a "real-world" clinical setting. This will be accomplished through the building of a transformative collaboration between research, education, and health systems operations to more effectively and efficiently provide patient care.

Detailed description: Millions of patients with chest pain are seen in Emergency Departments (EDs) every year. Over half of ED patients with chest pain are admitted to the hospital to undergo further testing. Despite high testing rates, less than 1 in 10 patients with chest pain are ultimately diagnosed with an acute coronary syndrome (ACS) at estimated annual cost of $13 billion. Current care patterns for acute chest pain fail to focus health system resources, such as hospitalization and cardiac testing, on patients most likely to benefit.

The HEART Pathway, which combines a clinical decision aid, with two serial troponin measurements, has been developed to identify patients with chest pain who can safely be discharged without objective cardiac testing (stress testing or angiography). Prior retrospective and observational studies have established that use of the HEART Pathway reduces cardiac testing by \>20%, while maintaining an acceptably low adverse event rate. We now seek to integrate the HEART Pathway into "real-world" clinical settings to determine effectiveness.

The goal of this proposal is to build a transformative collaboration bridging the gap between research, education, and health systems operations to more effectively and efficiently provide patient care. The vanguard for this collaboration seeks to improve quality of care for patients with acute chest pain by integrating the HEART Pathway into cardiovascular care delivery at Wake Forest Baptist Health (WFBH). This project will build on our prior work and provide a model for using the education and operational strengths of US academic medical centers to disseminate initiatives to improve care delivery.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 21 years of age at the time of Emergency Department (ED) visit
* Chest discomfort consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation.

Exclusion Criteria:

* New ST-segment elevation in contiguous leads on any electrocardiogram (\>/= 1 mV)

Primary outcomes:
measure: Hospitalization rate
timeFrame: 30 Days after Emergency Department Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Simon A Mahler, MD, MS
role: PRINCIPAL_INVESTIGATOR
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