Authors (including presenting author) :
Lam RPK(1)(2), Hung KKC(3)(4), Lui CT(5), Kwok WS(6), Lam WWT(7), Lau EHY(7), Sridhar S(8), Tsang TC(2), Graham CA(3)(4), Rainer TH(1)(2)
Affiliation :
(1)Department of Emergency Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong (2)Accident & Emergency Department, Queen Mary Hospital (3)Accident & Emergency Medicine Academic Unit, The Chinese University of Hong Kong (4)Accident & Emergency Department, Prince of Wales Hospital (5)Accident & Emergency Department, Tuen Mun Hospital (6)Accident & Emergency Department, Pamela Youde Nethersole Eastern Hospital (7)School of Public Health, The University of Hong Kong (8)Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong
Keyword 2: :
Emergency department
Keyword 3: :
Randomised controlled trial
Keyword 4: :
Implementation sciences
Keyword 5: :
Feasibility study
Introduction :
The uptake of the Surviving Sepsis Campaign Hour-1 Bundle remains low across healthcare settings. The NEWS-1 care is a novel sepsis care model, in which the Hour-1 Bundle is triggered objectively by a high National Early Warning Score 2 (≥5).
Objectives :
We aimed to determine the feasibility of a full-scale type 1 hybrid effectiveness-implementation multicentre trial on the NEWS-1 care in Hong Kong and to evaluate the implementation barriers and facilitators.
Methodology :
We conducted a pilot type 1 hybrid trial, which included a prospective stepped wedge cluster randomised controlled trial in four public EDs over 10 months and mixed-method implementation evaluation guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Feasibility was evaluated based on 14 progression criteria.
Result & Outcome :
Exploratory intention-to-treat analysis on 200 patients (standard care group n=102, NEWS-1 group n=98) showed no significant between-group difference in all-cause 30-day mortality (standard group 3·9%; NEWS-1 group 9·2%; absolute risk difference 5·3%, 95% confidence interval, –1·6% to 12·1%), 90-day all-cause mortality, in-patient mortality, sepsis-related mortality, needs for mechanical ventilation, renal replacement therapy, intensive care and surgery, ventilator free days and adverse events. During the implementation phase, the compliance rate with lactate, blood culture, antibiotics increased significantly. Implementation evaluation identified 28 barriers and facilitators. Thirteen progression criteria were met except the suboptimal bundle compliance (56·1%). Conclusions The effectiveness of the NEWS-1 care remained in equipoise and adverse events were rare. A full-scale hybrid trial is feasible but unlikely to demonstrate a survival benefit. Identified implementation barriers and facilitators can inform initiatives to improve ED sepsis care.
