ED Tracking Sheet Implementation

May 18, 2023 updated by: Harman S. Gill, Dartmouth-Hitchcock Medical Center
The purpose of this study is to assess whether implementation of an ED Sepsis Tracking Sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic Emergency Department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sepsis remains a common cause of morbidity and mortality in the hospital setting. Accurate diagnosis and timely initiation of therapy are important drivers of patient-centered outcomes in sepsis management. Compliance with the core measures listed in the surviving sepsis campaign guidelines has been variable.

An ED-specific Sepsis Tracking Sheet (STS) - a tool for implementing and documenting critical actions in sepsis management - was created at our institution by a team of physicians, nurses, and ED pharmacists. Dedicated ED pharmacists were instructed to fill this sheet within one hour of the sepsis-specific best practice advisory (BPA) being activated in the ED. Core measures associated with the one hour and three hour sepsis bundles were tracked and outcomes were compared pre- and post-implementation of the STS.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 years old
  • Initially evaluated in the DHMC Lebanon Emergency Department
  • Activated sepsis BPA upon initial presentation (triage history consistent with infection combined with 2 or more SIRS criteria? Are these the criteria that trigger our sepsis BPA?)

Exclusion Criteria:

  • Patients who are transferred to the DHMC Lebanon Emergency Department from another facility
  • Patients with absent data regarding one or more of the goal-directed sepsis criteria
  • Patients who did not initially meet criteria to trigger the sepsis BPA, but developed sepsis later in their hospital course

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-intervention
Patients presenting to the Emergency Department meeting severe sepsis criteria prior to implementation of an ED Sepsis Tracking Sheet
Experimental: Post-intervention
Patients presenting to the Emergency Department meeting severe sepsis criteria following implementation of an ED Sepsis Tracking Sheet
Procedure: ED Sepsis Tracking Sheet
Implementation of an ED Sepsis Tracking Sheet. This sheet will track time of patient presentation, time of High-Acuity Medical Response (HAMR) page, time of bilateral 18g or larger IV access, time of initial lactate, time two sets of blood cultures were sent, time antibiotics were administered as well as which antibiotics and what dose, time initial IV fluid bolus was completed, time repeat lactate was sent, timing of post-IV-fluid bolus vital signs, as well as the presence of persistent hypotension following this IV fluid bolus and whether or not vasopressors were applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of goal-directed sepsis criteria met
Time Frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Goal-directed sepsis criteria involve the following: 1) Was an initial lactate obtained? 2) Were two sets of blood cultures sent? 3) Were antibiotics given within one hour of identification of severe sepsis? 4) Was the patient given an initial IV fluid bolus? 5) Was a repeat lactate sent if the initial lactate was elevated? These five criteria will be assessed as "met" or "not met" for each patient. The total of "met" and "not met" criteria will be aggregated across patients. The percentage of goal-directed sepsis criteria met will be calculated as "met" criteria divided by the sum of "met" plus "not met" criteria.
Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Time of ED presentation to the time of in-hospital death or hospital discharge, measured in days.
Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
In-hospital mortality
Time Frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Death attributed to any cause occurring at any time between the patient's ED presentation and hospital discharge.
Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Harman Gill, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans for sharing IPD at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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