search
Back to results

ED Tracking Sheet Implementation

Primary Purpose

Sepsis, Severe Sepsis, Systemic Inflammatory Response Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED Sepsis Tracking Sheet
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring CMS Compliance, ED Pharmacist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-intervention

Post-intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of goal-directed sepsis criteria met
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

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

Full Information

First Posted
January 16, 2022
Last Updated
May 18, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05213923
Brief Title
ED Tracking Sheet Implementation
Official Title
ED Tracking Sheet Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Severe Sepsis, Systemic Inflammatory Response Syndrome
Keywords
CMS Compliance, ED Pharmacist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
No Intervention
Arm Description
Patients presenting to the Emergency Department meeting severe sepsis criteria prior to implementation of an ED Sepsis Tracking Sheet
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
Patients presenting to the Emergency Department meeting severe sepsis criteria following implementation of an ED Sepsis Tracking Sheet
Intervention Type
Procedure
Intervention Name(s)
ED Sepsis Tracking Sheet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of goal-directed sepsis criteria met
Description
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 Frame
Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Time of ED presentation to the time of in-hospital death or hospital discharge, measured in days.
Time Frame
Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Title
In-hospital mortality
Description
Death attributed to any cause occurring at any time between the patient's ED presentation and hospital discharge.
Time Frame
Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harman Gill, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans for sharing IPD at this time.
Citations:
PubMed Identifier
34599691
Citation
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.
Results Reference
background
PubMed Identifier
24335434
Citation
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.
Results Reference
background
PubMed Identifier
25275252
Citation
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.
Results Reference
background
PubMed Identifier
21220270
Citation
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.
Results Reference
background
PubMed Identifier
26903338
Citation
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.
Results Reference
background
PubMed Identifier
32572531
Citation
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.
Results Reference
background
PubMed Identifier
27805796
Citation
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.
Results Reference
background
PubMed Identifier
30872387
Citation
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.
Results Reference
background

Learn more about this trial

ED Tracking Sheet Implementation

We'll reach out to this number within 24 hrs