{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T16:30:29Z","timestamp":1777653029607,"version":"3.51.4"},"reference-count":58,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T00:00:00Z","timestamp":1706832000000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Heath and Medical Research Fund of the Food and Health Bureau of the Hong Kong Special Administrative Region","award":["19201161"],"award-info":[{"award-number":["19201161"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,1,24]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"\n Introduction<\/jats:title>\n Early 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\u2009mL\/kg crystalloid for hypotension\/lactate \u22654\u2009mmol\/L and vasopressors for hypotension during\/after fluid resuscitation within 1\u2009hour 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 (\u22655). 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.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n We 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.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n The 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.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT05731349<\/jats:ext-link>.<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-080676","type":"journal-article","created":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T23:25:19Z","timestamp":1706829919000},"page":"e080676","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["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"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05731349","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05731349","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5937-8989","authenticated-orcid":false,"given":"Rex Pui Kin","family":"Lam","sequence":"first","affiliation":[{"name":"Department of Emergency Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"},{"name":"Accident and Emergency Department, Queen Mary Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8706-7758","authenticated-orcid":false,"given":"Kevin Kei Ching","family":"Hung","sequence":"additional","affiliation":[{"name":"Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Hong Kong, China"},{"name":"Accident and Emergency Department, Prince of Wales Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chun Tat","family":"Lui","sequence":"additional","affiliation":[{"name":"Accident and Emergency Department, Tuen Mun Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wai Shing","family":"Kwok","sequence":"additional","affiliation":[{"name":"Accident and Emergency Department, Pamela Youde Nethersole Eastern Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wendy Wing Tak","family":"Lam","sequence":"additional","affiliation":[{"name":"School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric Ho Yin","family":"Lau","sequence":"additional","affiliation":[{"name":"School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Siddharth","family":"Sridhar","sequence":"additional","affiliation":[{"name":"Department of Microbiology, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter Yau Tak","family":"Ng","sequence":"additional","affiliation":[{"name":"Accident and Emergency Department, Tuen Mun Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chi Hung","family":"Cheng","sequence":"additional","affiliation":[{"name":"Accident and Emergency Department, Prince of Wales Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tat Chi","family":"Tsang","sequence":"additional","affiliation":[{"name":"Accident and Emergency Department, Queen Mary Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew Sik Hon","family":"Tsui","sequence":"additional","affiliation":[{"name":"Accident and Emergency Department, Queen Mary Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4381-7470","authenticated-orcid":false,"given":"Colin Alexander","family":"Graham","sequence":"additional","affiliation":[{"name":"Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Hong Kong, China"},{"name":"Accident and Emergency Department, Prince of Wales Hospital, Hospital Authority, Hong Kong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy Hudson","family":"Rainer","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 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