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

• Published in: Current controlled trials in cardiovascular medicine Vol. 24; no. 1; pp. 620 - 12
• Main Authors: Frank, Hannah E, Evans, Laura, Phillips, Gary, Dellinger, RPhillip, Goldstein, Jessyca, Harmon, Lori, Portelli, David, Sarani, Nima, Schorr, Christa, Terry, Kathleen M, Townsend, Sean R, Levy, Mitchell M
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 29.09.2023; BioMed Central; BMC
• Subjects: Aged; Care and treatment; Collaboration; Committees; Compliance; Critical care; Development and progression; Diagnosis; Electronic health records; Emergency medical care; Guideline Adherence; Hospital Mortality; Hospitals; Humans; Hypotension; Hypotheses; Implementation science; Medicare; Meetings; Mortality; Patients; Randomized Controlled Trials as Topic; Respiratory failure; Sepsis; Sepsis - diagnosis; Sepsis - therapy; Sepsis bundles; Septic shock; Shock, Septic; Study Protocol; United States; United States; United States > US; Sepsis bundles; Sepsis; Septic shock; Implementation science
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07644-y

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. 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. 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. NHLBI R01HL162954. ClinicalTrials.gov NCT05491941. Registered on August 8, 2022.