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
Introduction 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 mL/kg crystalloid for h...
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BMJ Publishing Group
2024-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/2/e080676.full |
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| author | Chi Hung Cheng Wendy Wing Tak Lam Rex Pui Kin Lam Kevin Kei Ching Hung Chun Tat Lui Wai Shing Kwok Eric Ho Yin Lau Siddharth Sridhar Peter Yau Tak Ng Tat Chi Tsang Matthew Sik Hon Tsui Colin Alexander Graham Timothy Hudson Rainer |
| author_facet | Chi Hung Cheng Wendy Wing Tak Lam Rex Pui Kin Lam Kevin Kei Ching Hung Chun Tat Lui Wai Shing Kwok Eric Ho Yin Lau Siddharth Sridhar Peter Yau Tak Ng Tat Chi Tsang Matthew Sik Hon Tsui Colin Alexander Graham Timothy Hudson Rainer |
| author_sort | Chi Hung Cheng |
| collection | DOAJ |
| description | Introduction 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 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 analysis 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.Ethics and dissemination 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.Trial registration number NCT05731349. |
| format | Article |
| id | doaj-art-ad1fdf337c0b42009f0cbe0b84ebc5b8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ad1fdf337c0b42009f0cbe0b84ebc5b82025-08-20T03:40:51ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-080676Early 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) protocolChi Hung Cheng0Wendy Wing Tak Lam1Rex Pui Kin Lam2Kevin Kei Ching Hung3Chun Tat Lui4Wai Shing Kwok5Eric Ho Yin Lau6Siddharth Sridhar7Peter Yau Tak Ng8Tat Chi Tsang9Matthew Sik Hon Tsui10Colin Alexander Graham11Timothy Hudson Rainer12Accident and Emergency Department, Prince of Wales Hospital, Hospital Authority, Hong Kong, ChinaSchool of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaDepartment of Emergency Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaAccident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Hong Kong, ChinaAccident and Emergency Department, Tuen Mun Hospital, Hospital Authority, Hong Kong, ChinaAccident and Emergency Department, Pamela Youde Nethersole Eastern Hospital, Hospital Authority, Hong Kong, ChinaSchool of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaDepartment of Microbiology, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaAccident and Emergency Department, Tuen Mun Hospital, Hospital Authority, Hong Kong, ChinaAccident and Emergency Department, Queen Mary Hospital, Hospital Authority, Hong Kong, ChinaAccident and Emergency Department, Queen Mary Hospital, Hospital Authority, Hong Kong, ChinaAccident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Hong Kong, ChinaDepartment of Emergency Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaIntroduction 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 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 analysis 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.Ethics and dissemination 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.Trial registration number NCT05731349.https://bmjopen.bmj.com/content/14/2/e080676.full |
| spellingShingle | Chi Hung Cheng Wendy Wing Tak Lam Rex Pui Kin Lam Kevin Kei Ching Hung Chun Tat Lui Wai Shing Kwok Eric Ho Yin Lau Siddharth Sridhar Peter Yau Tak Ng Tat Chi Tsang Matthew Sik Hon Tsui Colin Alexander Graham Timothy Hudson Rainer 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 BMJ Open |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/2/e080676.full |
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