PARA-HEART Pilot Implementation (PARA-HEART)

March 3, 2022 updated by: Wake Forest University Health Sciences

Can Pre-Hospital Use of the HEART Score and Abbott i-STAT® Point-of-Care Troponin Predict Major Adverse Cardiovascular Events: the PARA-HEART Pilot Implementation

Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing.While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients.Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing.

Study Overview

Status

Completed

Conditions

Detailed Description

Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause. Missing the diagnosis of ACS is associated with high rates of morbidity, mortality, and malpractice claims. Therefore, to avoid missing the diagnosis of ACS, patients with chest pain typically undergo extensive evaluations at an estimated cost of $10-13 billion annually. However, less than 10% of these patients are ultimately diagnosed with ACS. As the US healthcare system shifts towards a value-based model, it is clear that the current care patterns for acute chest pain, which fail to focus health system resources, such as hospitalization and cardiac testing, on patients most likely to benefit, are not sustainable.

In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing. The HEART Pathway, which utilizes an easy to use clinical decision aid (the HEART score) and serial troponin measurement, has been shown to significantly reduce objective cardiac testing (stress testing and coronary angiography), shorten hospital length of stay, and increase the early discharge rate from the Emergency Department among patients with acute chest pain. These important efficiency gains occur without missing ACS and without increasing return visits to the ED or downstream admissions to the hospital over a 30 day period.

While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients. Therefore, integrating objective risk stratification tools, such as the HEART score and point-of-care troponin testing, into Emergency Medical Services (EMS) triage and destination plans represents an opportunity to improve care. Furthermore, expanding use of the HEART score to paramedics in the pre-hospital setting is a natural extension of our prior work, especially given the growing sophistication of mobile integrated healthcare ("community paramedicine") over the last decade. Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed.

The investigators anticipate that a standardized approach to paramedic risk stratification using the HEART score with Abbott's i-STAT® POC troponin testing will be feasible and achieve high accuracy for the detection of ACS. Ultimately the investigators believe this planned implementation will improve the quality and value of chest pain care. Placing these tools in the hands of our first responders will identify patients with ACS earlier and speed the delivery of potentially life-saving care. For example, EMS triage and destination plans (chest pain treatment and transportation triage and destination plans) could be amended so that patients with positive POC troponins or high HEART scores could be transported directly to a hospital with cardiac catheterization capabilities, avoiding delays and costs associated with inter-facility transfers. However, before EMS triage and destination plans can fully incorporate the HEART score and POC troponin testing, first the feasibility of such an implementation must be established by collecting quality surveillance data.

To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing. This pilot will include paramedics from three demographically distinct counties (Forsyth, Surry, and Stokes counties) in North Carolina, who will begin using the HEART score and i-STAT POC Troponin as part of their risk assessment for patients with acute chest pain. However, EMS triage and transportation plans will not be altered based on the HEART score assessment until feasibility and accuracy have been established. To ensure the feasibility and accuracy of paramedic chest pain risk assessment the investigators will be performing surveillance of electronic health records (EHR) and contacting patients by phone (which is a common practice in EMS quality assurance). Quality surveillance participants (n=500) will be identified retrospectively and quality assurance data will be collected electronically using EHR (EMS records, and Wake Forest Baptist Health health records) and via telephone follow-up calls (which are customary in EMS quality assurance projects).

Study Type

Observational

Enrollment (Actual)

511

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with symptoms concerning for acute coronary syndrome who are being transported to the Wake Forest Baptist Medical Center Emergency Department by paramedics trained to complete a HEART Score and POC troponin assessment will be eligible for inclusion in this quality surveillance study.

Description

Inclusion Criteria:

  • age greater than or equal to 21 years
  • Non-traumatic chest discomfort or other symptoms consistent with possible
  • Patient being transported to Wake Forest Baptist Health ED for further care

Exclusion Criteria:

  • ST-segment elevation in contiguous leads on any electrocardiogram
  • Inter-facility transfers
  • Short Pre-hospital times: anticipated scene + transportation time less than 5 mins
  • Unstable vitals signs
  • Known terminal diagnosis with life expectancy less than 1 year
  • Concomitant non-cardiac medical, surgical, or psychiatric emergency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pre-hospital HEART Score
All subjects included in this quality surveillance study will have had a HEART score, including POC troponin calculated by paramedics prior to arrival at the emergency department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE) at 30 days
Time Frame: 30 Days
The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of objective cardiac testing
Time Frame: 30 Days
Objective cardiac testing will be defined by any stress testing modality, coronary computed tomography (CT) angiography, or invasive coronary angiography.
30 Days
Length of Stay
Time Frame: 30 Days
Length of stay (LOS) will be the time from ED arrival to hospital discharge for all patients, whether admitted or not.
30 Days
Rate of hospitalization at index
Time Frame: 30 Days
Index visit hospitalization will be defined as an inpatient or observation admission (including Observation Unit evaluations with stress testing or cardiac imaging).
30 Days
Rate of cardiac related hospital admissions and ED visits during follow-up
Time Frame: 30 Days
Hospital admissions and ED visits occurring during the 30 day follow up period will be categorized as cardiac-related if a cardiac procedure is performed, the primary reason for admission/visit is chest pain, possible ACS, or a discharge diagnosis relates to chest pain, myocardial infarction (MI), acute coronary syndrome, heart failure, dysrhythmias, pericardial disease, or other cardiac disease. Cardiac procedures include cardiac imaging / stress testing (excluding resting echo), coronary revascularization, and pacemaker or defibrillator insertion.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Simon Mahler, MD, MS, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00036229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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