ED Tracking Sheet Implementation

NCT ID: NCT05213923

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis Severe Sepsis Systemic Inflammatory Response Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-intervention

Patients presenting to the Emergency Department meeting severe sepsis criteria prior to implementation of an ED Sepsis Tracking Sheet

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-intervention

Patients presenting to the Emergency Department meeting severe sepsis criteria following implementation of an ED Sepsis Tracking Sheet

Group Type EXPERIMENTAL

ED Sepsis Tracking Sheet

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Harman S. Gill

Principal Investigator, Assistant Professor of Emergency Medicine and Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harman Gill, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34599691 (View on PubMed)

Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014 Jan 1;5(1):4-11. doi: 10.4161/viru.27372. Epub 2013 Dec 11.

Reference Type BACKGROUND
PMID: 24335434 (View on PubMed)

Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723.

Reference Type BACKGROUND
PMID: 25275252 (View on PubMed)

Coba V, Whitmill M, Mooney R, Horst HM, Brandt MM, Digiovine B, Mlynarek M, McLellan B, Boleski G, Yang J, Conway W, Jordan J; (The Henry Ford Hospital Sepsis Collaborative Group). Resuscitation bundle compliance in severe sepsis and septic shock: improves survival, is better late than never. J Intensive Care Med. 2011 Sep-Oct;26(5):304-13. doi: 10.1177/0885066610392499. Epub 2011 Jan 10.

Reference Type BACKGROUND
PMID: 21220270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.

Reference Type BACKGROUND
PMID: 32572531 (View on PubMed)

Schorr C, Odden A, Evans L, Escobar GJ, Gandhi S, Townsend S, Levy M. Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J Hosp Med. 2016 Nov;11 Suppl 1:S32-S39. doi: 10.1002/jhm.2656.

Reference Type BACKGROUND
PMID: 27805796 (View on PubMed)

Downing NL, Rolnick J, Poole SF, Hall E, Wessels AJ, Heidenreich P, Shieh L. Electronic health record-based clinical decision support alert for severe sepsis: a randomised evaluation. BMJ Qual Saf. 2019 Sep;28(9):762-768. doi: 10.1136/bmjqs-2018-008765. Epub 2019 Mar 14.

Reference Type BACKGROUND
PMID: 30872387 (View on PubMed)

Other Identifiers

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STUDY02001224

Identifier Type: -

Identifier Source: org_study_id

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