Prehospital Translation of Chest Pain Tools

Completed

• Conditions: Pulmonary Embolism; Acute Coronary Syndrome
• Interventions: Other: Data Collection

• Registration Number: NCT03494556
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary Embolism (PE) and have become standard practice in the ED setting. This study seeks to determine whether prehospital use of these decision aids is feasible and determine which are the most sensitive and specific for prediction of ACS and PE, respectively.

Detailed Description

To accomplish our Specific Aims the study team proposes a prospective, observational pilot study of four rapid risk stratification tools, the HEART Pathway Score, EDACS score, revised Geneva score, and PERC score, among 250 chest pain patients within two large EMS systems. The proposed pilot study has broad-based support from local and state EMS agencies, including Cumberland and New Hanover County EMS agencies. Each tool will be pilot tested and compared in the prehospital setting for feasibility and accuracy. Paramedics will be trained in risk stratification tool use and then will prospectively collect the clinical data needed to calculate each risk stratification score when caring for adults with chest pain. Completed paramedic risk assessments will be used to determine feasibility. Patients will be followed for 30 days to determine occurrence of ACS and PE events and the sensitivity of each risk stratification decision aid will be determined.

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Study Start: 2018-04-18
• Primary Completion: 2019-02-18
• Status Verified: 2019-10
• Study Completion: 2020-09-09
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

• Age greater than or equal to 21
• Acute non-traumatic chest pain
• Transported by Cumberland or New Hanover County EMS to a local Emergency Department

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Exclusion Criteria

• Patients with evidence of ST elevation myocardial infarction (STEMI) on ECG
• Inter-facility transports (transfers)
• Patients with unstable vital signs
• Prisoners
• Non-english speakers

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Intervention	Data Collection	Paramedic will use data collected during routine care to complete four risk stratification tools.

Primary Outcome Measures

Name	Time	Method
Determine whether prehospital chest pain decision aid use is feasible.	24 hours	Paramedics and blinded Emergency Department providers will be complete four risk stratification tools on a convenience sample of patients with acute chest pain. Inter-rater reliability (kappa) will be determined for each tool.

Secondary Outcome Measures

Name	Time	Method
Compare decision aids to determine which are the most sensitive and specific	30 days	Destination hospitals have well established linkages between the prehospital and hospital Electronic Medical Record (EMR) facilitating patient outcome ascertainment. Data will be abstracted from the EMR to determine occurrence of 30 day study outcomes.

Trial Locations

Locations (2)

Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS; 🇺🇸 Fayetteville, North Carolina, United States

New Hanover Regional Medical Center EMS; 🇺🇸 Wilmington, North Carolina, United States