Field Paramedic Application of Sepsis Triage (FAST)

Given the implementation of the Hamilton Early Warning Score (HEWS) and the use of capnography by paramedics, this study will involve a large multi-site retrospective evaluation (before vs after implementation) of the HEWS score and comparison of the HEWS to systemic inflammatory response syndrome (SIRS), quick Sepsis Related Organ failure Assessment (qSOFA) and Modified Early Warning Score (MEWS) when applied retrospectively for the identification of sepsis in the prehospital setting.

Study Overview

• Status: Unknown
• Conditions: Sepsis

Detailed Description

1. To determine the accuracy of the HEWS score, compared to qSOFA, and SIRS for early sepsis recognition when used in the prehospital setting by paramedics for the identification of patients with sepsis or suspected sepsis.
2. To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.
3. To identify the before and after healthcare outcomes of a prehospital sepsis alert program.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Natasha Clayton, CRA, RA; Phone Number: 44832 905-521-2100; Email: clayton@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8E 5E3
      • Recruiting
      • Centre for Paramedic Education and Research, Hamilton Health Sciences
      • Contact: Natasha Clayton, CRA, RA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with suspected infection.

Description

Inclusion Criteria:

Any patient to which paramedics apply the Hamilton Early Warning Score or patients who arrive to the Emergency Department (ED) by ambulance without a pre-alert and meet the definition of sepsis in the ED will also be included, and patient is ≥ 18 years

Exclusion Criteria:

Patient is an inter-facility transfer, or patients with absent vital signs are absent, or death before blood can be drawn in the Emergency Department, or the patient fits the criteria for another prehospital alert (ST-elevation myocardial infarction, cerebrovascular vascular accident, or trauma)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective; The Investigators will examine data from 1-year prior to paramedic implementation of the Hamilton Early Warning Score tool.
Prospective; The Investigators will examine data from 1-year after paramedic implementation of the Hamilton Early Warning Score tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of HEWS	To determine the accuracy of the HEWS score, compared to qSOFA, and SIRS for early sepsis recognition when used in the prehospital setting by paramedics for the identification of patients with sepsis or suspected sepsis.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the addtion of end-tidal carbon dioxide (ETCO2) values	To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.	1 year
Evaluate sepsis alert program	To identify the before and after healthcare outcomes of a prehospital sepsis alert program.	2 years

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Hamilton Academic Health Sciences Organization
• Investigators: Principal Investigator: Michelle Wellsford, MD, Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
• Canadian Institute for Health Information. In Focus: A National Look at Sepsis.; 2009. https://secure.cihi.ca/free_products/HSMR_Sepsis2009_e.pdf.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2016
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: sepsis, septic shock, early warning scores, infecion
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 3075-C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No