Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

This study is currently recruiting participants.
Verified September 2013 by Wake Forest Baptist Health
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Simon Mahler, MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01665521
First received: August 7, 2012
Last updated: September 6, 2013
Last verified: September 2013

August 7, 2012
September 6, 2013
September 2012
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01665521 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
 
Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Chest Pain
Other: HEART Pathway
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
  • 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.
    Intervention: Other: HEART Pathway
  • No Intervention: Usual Care
    Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
282
March 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Stephanie Bradshaw Elliott, B.S. 336-716-5943 sbradsha@wakehealth.edu
Contact: Erin Harper, M.S.H.S. 336-716-2059 erharper@wakehealth.edu
United States
 
NCT01665521
12CRP12000001, IRB00021074
Yes
Simon Mahler, MD, Wake Forest University Baptist Medical Center
Wake Forest Baptist Health
American Heart Association
Principal Investigator: Simon A Mahler, MD Wake Forest Baptist Health
Wake Forest Baptist Health
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP