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Completed

NCT Number: NCT02056964

HEART Pathway Implementation

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Hospitalization rate

    Time frame: 30 Days after Emergency Department Visit

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Association of American Medical Colleges
  • Donaghue Medical Research Foundation

Registry information

Official study title

The HEART Pathway: Bridging the Gap Between Operations, Research, and Education

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2014
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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