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. 2023 Sep 29;24(1):620.
doi: 10.1186/s13063-023-07644-y.

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

Hannah E Frank  1 , Laura Evans  2 , Gary Phillips  3 , RPhillip Dellinger  4 , Jessyca Goldstein  5 , Lori Harmon  6 , David Portelli  7 , Nima Sarani  8 , Christa Schorr  9 , Kathleen M Terry  10 , Sean R Townsend  11 , Mitchell M Levy  12
Affiliations

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

Hannah E Frank et al. Trials. .

Abstract

Background: Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis "bundles" (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle.

Method: The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes.

Discussion: This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles.

Funding: NHLBI R01HL162954.

Trial registration: ClinicalTrials.gov NCT05491941. Registered on August 8, 2022.

Keywords: Implementation science; Sepsis; Sepsis bundles; Septic shock.

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Conflict of interest statement

Dr. Evans is co-chair Adult Surviving Sepsis Guidelines, co-author of SSC 1-h bundle, and member of Scientific Advisory Board for Endpoint Health (USA). Dr. Dellinger has held a leadership position Surviving Sepsis Campaign 2002–2016. Dr. Schorr has been in a leadership position for the Surviving Sepsis Campaign from 2006 to present, and is a paid consultant on the current grant (R01HL162954). Dr. Townsend is a measure steward for the Centers for Medicare and Medicaid Services sepsis quality measure. Dr. Levy receives funding from T32 HL134625, 1RO1HL162954-0, is co-author of the SSC 1-h bundle, and is on scientific advisory boards for Inotrem (France) and Endpoint Health (USA). All other authors declare that they have no competing interests.

Figures

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Fig. 1
Study timeline
Fig. 2
Fig. 2
SPIRIT checklist: Schedule of enrollment, interventions and assessment
See this image and copyright information in PMC

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