HEART Pathway Implementation

NCT ID: NCT02056964

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14717 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-01-31

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.

Conditions

Chest Pain; Acute Coronary Syndrome; Chest Pain Atypical Syndrome; Chest Pain Rule Out Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Post-HEART Pathway Implementation

Data will be collected on patients presenting to the Emergency Department (ED) with chest pain after implementation of the HEART Pathway decision aid.

No interventions assigned to this group

Pre-HEART Pathway Implementation

Data will be collected on patients presenting to the Emergency Department (ED) with chest pain prior to Implementation of the HEART Pathway decision aid.

No interventions assigned to this group

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association of American Medical Colleges

OTHER

Sponsor Role: collaborator

Donaghue Medical Research Foundation

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon A Mahler, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

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Related Links

http://www.wakehealth.edu

Wake Forest Baptist Medical Center

Other Identifiers

IRB00025114

Identifier Type: -

Identifier Source: org_study_id