PARA-HEART Pilot Implementation



Status:Completed
Conditions:Angina, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:10/3/2018
Start Date:December 2016
End Date:August 30, 2018

Use our guide to learn which trials are right for you!

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.

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).

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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Principal Investigator: Simon Mahler, MD, MS
Phone: 336-716-5943
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials