Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02709135
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2016-03-03
Brief Title:
PARA-HEART Pilot Implementation
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARA-HEART
Brief 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 causeIn 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 testingWhile 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 patientsThus multidisciplinary leaders within Emergency Medicine Cardiology and Prehospital Medicine have agreed that a limitedpilot evaluation of the HEART Score with Abbotts 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
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 limitedpilot evaluation of the HEART Score with Abbotts 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 Abbotts 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 n500 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
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 limitedpilot evaluation of the HEART Score with Abbotts 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 Abbotts 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 n500 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None