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)

NCT06657625 | Enrolling By Invitation

• 1 other identifier: 29BRC24.0223 - IPA-SOS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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 sepsis/septic 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.

Conditions

Sepsis; Septic Shock; Critical Illness; Emergency Medicine; Surviving Sepsis Campaign; Sepsis Performance Improvement Program; Sepsis Team

Outcome Measures

Primary Outcomes (1)

• Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy

  Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy in minutes. From ION assessment to the first antibiotic administration in the emergency departement.

  Up to 6 hours

Secondary Outcomes (10)

• Quality of selected antibiotic therapy

  Up to 6hours

• Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation

  Up to 6 hours

• Quality of fluid resuscitation

  Up to 3 hours

• Quality of oxygen therapy

  Up to 6 hours

• Proportion of sepsis patients progressing to septic shock in the emergency department

  Up to 6 hours

Study Arms (2)

Pre-implementation cohort

Patients from January 1, 2017, to December 31, 2017, before the implementation of the performance improvement program.

Post-implementation cohort

Patients from May 1, 2022, to April 30, 2024, after the implementation of the performance improvement program.

Other: Sepsis Performance Improvement Program

Interventions

Sepsis Performance Improvement Program OTHER

Training/awareness for medical and paramedical staff; creation of informational posters; development of an institutional pathway in the emergency department; creation of a protocol ; establishment of a sepsis team with a dedicated contact number.

Also known as: Implementation of a Performance Improvement Program, Performance Improvement Program

Post-implementation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with blood cultures collected and a SOFA score ≥ 2 presenting to the emergency department of Brest University Hospital, between January 1, 2017, to December 31, 2017 and May 1, 2022, to April 30, 2024.

You may qualify if:

• Major
• Patients with positive blood cultures and a positive SOFA score
• Patients with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
• Patients enrolled in a social security scheme

You may not qualify if:

• Patients under judicial protection (guardianship, curatorship, etc.)
• Refusal to participate
• Pregnant patients

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

Related Publications (6)

• Rezig S, Branthome S, Basset A, Helies R, Fiore C, Bailly P, et al. Une "Sepsis Team" est elle indispensable dans chaque hopital ? Médecine Mal Infect. 1 juin 2019;49:S55-6.

  BACKGROUND

• Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

  PMID: 31954465 BACKGROUND

• Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015.

  PMID: 25946168 BACKGROUND

• 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, Hylander Moller M, 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. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.

  PMID: 34605781 BACKGROUND

• Chiu C, Legrand M. Epidemiology of sepsis and septic shock. Curr Opin Anaesthesiol. 2021 Apr 1;34(2):71-76. doi: 10.1097/ACO.0000000000000958.

  PMID: 33492864 BACKGROUND

• Schinkel M, Holleman F, Vleghels R, Brugman K, Ridderikhof ML, Dzelili M, Nanayakkara PWB, Wiersinga WJ. The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. Infection. 2023 Aug;51(4):945-954. doi: 10.1007/s15010-022-01957-x. Epub 2022 Nov 17.

  PMID: 36394818 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 24, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)