Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657625
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Impact of the Introduction of a Performance Improvement Program on the Initial Management of Sepsis and Septic Shock in Adults in the Emergency Department a Before-and-after Study IPA-SOS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of the Introduction of a Performance Improvement Program on the Initial Management of Sepsis and Septic Shock in Adults in the Emergency Department a Before-and-after Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPA-SOS
Brief Summary:
The goal of this observational study is to evaluate if a performance improvement program can improve the initial management of sepsis and septic shock in adults at Brest University Hospital The study will include adult patients with positive blood cultures and a positive SOFA Sequential Organ Failure Essessment score or with blood cultures collected a positive SOFA score and sepsisseptic shock confirmed by the sepsis team at Brest University Hospital
The main questions it aims to answer are
Does the implementation of a performance improvement program increase adherence to the 2021 Surviving Sepsis Campaign SSC guidelines
Does the program improve patient outcomes such as 90-day mortality progression to septic shock and length of stay in the ICU and hospital
Researchers will compare patients from two periods pre-implementation January 1 2017 to December 31 2017 and post-implementation May 1 2022 to April 30 2024 to see if the performance improvement program leads to better compliance with SSC guidelines and improved patient outcomes
Participants will
Have their clinical data such as blood cultures SOFA scores and treatment times collected and analyzed
Be monitored for time to antibiotic therapy initial fluid resuscitation and other key treatment interventions following the recognition of sepsis or septic shock
The main questions it aims to answer are
Does the implementation of a performance improvement program increase adherence to the 2021 Surviving Sepsis Campaign SSC guidelines
Does the program improve patient outcomes such as 90-day mortality progression to septic shock and length of stay in the ICU and hospital
Researchers will compare patients from two periods pre-implementation January 1 2017 to December 31 2017 and post-implementation May 1 2022 to April 30 2024 to see if the performance improvement program leads to better compliance with SSC guidelines and improved patient outcomes
Participants will
Have their clinical data such as blood cultures SOFA scores and treatment times collected and analyzed
Be monitored for time to antibiotic therapy initial fluid resuscitation and other key treatment interventions following the recognition of sepsis or septic shock
Detailed Description:
Sepsis and septic shock are conditions with a significant public health impact yet the incidence of sepsis continues to rise To improve the management of these conditions experts recommend implementing performance improvement programs These recommendations were applied at Brest University Hospital in 2018 including the creation of a sepsis team responsible for prevention education and providing guidance and advice on sepsis and septic shock The team consists of infectious disease specialists emergency physicians and critical care doctors
Due to the heterogeneity of such programs worldwide it is important to assess the effectiveness of the performance improvement program at Brest University Hospital by evaluating adherence to the 2021 Surviving Sepsis Campaign SSC guidelines before and after its implementation
The study will include adult patients with positive blood cultures and a positive SOFA score or with blood cultures collected a positive SOFA score and sepsisseptic shock confirmed by the sepsis team at Brest University Hospital Two periods from 01012017 to 31122017 and from 01052022 to 30042024
The pre- and post-implementation groups will be compared with the primary outcome being compliance with the 2021 SSC recommendations antibiotic therapy hemodynamic management respiratory support corticosteroid therapy Secondary outcomes include time from admission to first physician contact time from first contact to initiation of antibiotic therapy time from first contact to first fluid resuscitation the proportion of sepsis patients progressing to septic shock in the emergency department length of ICU and hospital stay 90-day mortality duration of mechanical ventilation and changes in SOFA score at 24 hours Day 2 and Day 7
The role of the Initial Orientation Nurse ION is integrated into the evaluation criteria Using a triage grid sometimes in collaboration with the senior emergency physician or resuscitation physician the ION determines the optimal time frame for care and the most appropriate treatment pathway The ION plays a key role in the early recognition of sepsisseptic shock
The investigators will consider the time from patient evaluation by the ION to assess the speed of activation of the appropriate care pathway and the promptness of sepsisseptic shock management after recognition
The objective of this study is to evaluate the impact of implementing a performance improvement program on the initial management of sepsis and septic shock in adults in the emergency medicine department of Brest University Hospital guided by the 2021 Surviving Sepsis Campaign SSC guidelines
Due to the heterogeneity of such programs worldwide it is important to assess the effectiveness of the performance improvement program at Brest University Hospital by evaluating adherence to the 2021 Surviving Sepsis Campaign SSC guidelines before and after its implementation
The study will include adult patients with positive blood cultures and a positive SOFA score or with blood cultures collected a positive SOFA score and sepsisseptic shock confirmed by the sepsis team at Brest University Hospital Two periods from 01012017 to 31122017 and from 01052022 to 30042024
The pre- and post-implementation groups will be compared with the primary outcome being compliance with the 2021 SSC recommendations antibiotic therapy hemodynamic management respiratory support corticosteroid therapy Secondary outcomes include time from admission to first physician contact time from first contact to initiation of antibiotic therapy time from first contact to first fluid resuscitation the proportion of sepsis patients progressing to septic shock in the emergency department length of ICU and hospital stay 90-day mortality duration of mechanical ventilation and changes in SOFA score at 24 hours Day 2 and Day 7
The role of the Initial Orientation Nurse ION is integrated into the evaluation criteria Using a triage grid sometimes in collaboration with the senior emergency physician or resuscitation physician the ION determines the optimal time frame for care and the most appropriate treatment pathway The ION plays a key role in the early recognition of sepsisseptic shock
The investigators will consider the time from patient evaluation by the ION to assess the speed of activation of the appropriate care pathway and the promptness of sepsisseptic shock management after recognition
The objective of this study is to evaluate the impact of implementing a performance improvement program on the initial management of sepsis and septic shock in adults in the emergency medicine department of Brest University Hospital guided by the 2021 Surviving Sepsis Campaign SSC guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None