PARA-HEART Pilot Implementation

Acute Coronary Syndrome Clinical Trial

— PARA-HEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709135
• Other study ID #: IRB00036229
• Status: Completed
• Start date: December 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: September 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Locations

Country	Name	City	State
United States	Wake Forest School Of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE) at 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	Rate of objective cardiac testing	Objective cardiac testing will be defined by any stress testing modality, coronary computed tomography (CT) angiography, or invasive coronary angiography.	30 Days
Secondary	Length of Stay	Length of stay (LOS) will be the time from ED arrival to hospital discharge for all patients, whether admitted or not.	30 Days
Secondary	Rate of hospitalization at index	Index visit hospitalization will be defined as an inpatient or observation admission (including Observation Unit evaluations with stress testing or cardiac imaging).	30 Days
Secondary	Rate of cardiac related hospital admissions and ED visits during follow-up	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