Early sepsis care with the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the emergency department: hybrid type 1 effectiveness-implementation pilot stepped wedge randomised controlled trial (NEWS-1 TRIPS) protocol

• Published in: BMJ open Vol. 14; no. 2; p. e080676
• Main Authors: Lam, Rex Pui Kin, Hung, Kevin Kei Ching, Lui, Chun Tat, Kwok, Wai Shing, Lam, Wendy Wing Tak, Lau, Eric Ho Yin, Sridhar, Siddharth, Ng, Peter Yau Tak, Cheng, Chi Hung, Tsang, Tat Chi, Tsui, Matthew Sik Hon, Graham, Colin Alexander, Rainer, Timothy Hudson
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 01.02.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: accident & emergency medicine; Antibiotics; Clinical medicine; Early Warning Score; Emergency medical care; Emergency medicine; Emergency Service, Hospital; Endorsements; Feasibility; feasibility studies; Hospitals; Humans; Hypotension; Infections; infectious diseases; Intervention; Lactates; Mortality; Patients; Physiology; Pilot projects; qualitative research; randomized controlled trial; Randomized Controlled Trials as Topic; Sepsis; Sepsis - diagnosis; Sepsis - therapy; Vital signs; Hong Kong China; China; feasibility studies; qualitative research; accident & emergency medicine; infectious diseases; randomized controlled trial
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-080676

IntroductionEarly sepsis treatment in the emergency department (ED) is crucial to improve patient survival. Despite international promulgation, the uptake of the Surviving Sepsis Campaign (SSC) Hour-1 Bundle (lactate measurement, blood culture, broad-spectrum antibiotics, 30 mL/kg crystalloid for hypotension/lactate ≥4 mmol/L and vasopressors for hypotension during/after fluid resuscitation within 1 hour of sepsis recognition) is low across healthcare settings. Delays in sepsis recognition and a lack of high-quality evidence hinder its implementation. We propose a novel sepsis care model (National Early Warning Score, NEWS-1 care), in which the SSC Hour-1 Bundle is triggered objectively by a high NEWS-2 (≥5). This study aims to determine the feasibility of a full-scale type 1 hybrid effectiveness-implementation trial on the NEWS-1 care in multiple EDs.Methods and analysisWe will conduct a pilot type 1 hybrid trial and prospectively recruit 200 patients from 4 public EDs in Hong Kong cluster randomised in a stepped wedge design over 10 months. All study sites will start with an initial period of standard care and switch in random order at 2-month intervals to the NEWS-1 care unidirectionally. The implementation evaluation will employ mixed methods guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, which includes qualitative and quantitative data from focus group interviews, staff survey and clinical record reviews. We will analyse the 14 feasibility outcomes as progression criteria to a full-scale trial, including trial acceptability to patients and staff, patient and staff recruitment rates, accuracy of sepsis screening, protocol adherence, accessibility to follow-up data, safety and preliminary clinical impacts of the NEWS1 care, using descriptive statistics.Ethics and disseminationThe institutional review boards of all study sites approved this study. This study will establish the feasibility of a full-scale hybrid trial. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities.Trial registration numberNCT05731349.