HEART Pathway Implementation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest Baptist Health
Sponsor:
Collaborators:
Association of American Medical Colleges
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Simon Mahler, MD, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT02056964
First received: February 4, 2014
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The HEART Pathway: Bridging the Gap Between Operations, Research, and Education

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Hospitalization rate [ Time Frame: 30 Days after Emergency Department Visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: November 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056964

Contacts
Contact: Erin N Harper, MSHS, CCRP 336-716-2059 erharper@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Erin N Harper, MSHS, CCRP    336-716-2059    erharper@wakehealth.edu   
Principal Investigator: Simon A Mahler, MD, MS         
Sponsors and Collaborators
Wake Forest Baptist Health
Association of American Medical Colleges
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Simon A Mahler, MD, MS Wake Forest Baptist Health
  More Information

Additional Information:
Publications:
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):974.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24.

Responsible Party: Simon Mahler, MD, Assistant Professor, Wake Forest Baptist Health
ClinicalTrials.gov Identifier: NCT02056964     History of Changes
Other Study ID Numbers: IRB00025114
Study First Received: February 4, 2014
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Acute Coronary Syndrome
Chest Pain
Risk Stratification
Clinical Decision Aid
Emergency Department
Low Risk Chest Pain
Non Cardiac Chest Pain

Additional relevant MeSH terms:
Chest Pain
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris

ClinicalTrials.gov processed this record on August 19, 2014