Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.

Area of Science:

• Critical Care Medicine
• Implementation Science
• Health Services Research

Background:

• Sepsis is a major cause of ICU admission and mortality.
• Sepsis bundles, like the 3-hour bundle, are national standards for early management.
• Emerging data suggest earlier intervention (1-hour bundle) may improve mortality.

Purpose of the Study:

• To evaluate the clinical outcomes of initiating the 3-hour sepsis bundle within 1 hour versus 3 hours of recognition.
• To assess the effectiveness of a rigorous implementation strategy on adherence to sepsis bundles.
• To identify sepsis phenotypes and their impact on treatment outcomes.

Main Methods:

• A cluster-randomized trial conducted in the Emergency Department across 18 sites.
• Comparing clinical outcomes between the 1-hour and 3-hour sepsis bundle initiation.
• Utilizing an implementation science framework to enhance bundle compliance.

Main Results:

• The study is designed to provide data on the effectiveness of the 1-hour sepsis bundle.
• It will quantify the impact of an implementation strategy on bundle compliance.
• Secondary analysis will explore the role of clinical sepsis phenotypes.

Conclusions:

• This cluster-randomized trial uses a hybrid effectiveness-implementation design.
• The findings will rigorously evaluate the 1-hour and 3-hour sepsis bundles.
• The study is expected to significantly impact clinical practice in sepsis management.