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ED Tracking Sheet Implementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05213923
Recruitment Status : Completed
First Posted : January 28, 2022
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Harman S. Gill, Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sepsis Severe Sepsis Systemic Inflammatory Response Syndrome Procedure: ED Sepsis Tracking Sheet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ED Tracking Sheet Implementation
Actual Study Start Date : July 1, 2021
Actual Primary Completion Date : June 1, 2022
Actual Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05213923


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Harman Gill, MD Dartmouth-Hitchcock Medical Center
More Information
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Publications:
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

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Responsible Party: Harman S. Gill, Principal Investigator, Assistant Professor of Emergency Medicine and Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT05213923    
Other Study ID Numbers: STUDY02001224
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans for sharing IPD at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harman S. Gill, Dartmouth-Hitchcock Medical Center:
CMS Compliance
ED Pharmacist
Additional relevant MeSH terms:
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Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infections
 Inflammation
Pathologic Processes
Shock