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

Rex Pui Kin Lam, Kevin Kei Ching Hung, Chun Tat Lui, Wai Shing Kwok, Wendy Wing Tak Lam, Eric Ho Yin Lau, Siddharth Sridhar, Peter Yau Tak Ng, Chi Hung Cheng, Tat Chi Tsang, Matthew Sik Hon Tsui, Colin Alexander Graham, Timothy Hudson Rainer, Rex Pui Kin Lam, Kevin Kei Ching Hung, Chun Tat Lui, Wai Shing Kwok, Wendy Wing Tak Lam, Eric Ho Yin Lau, Siddharth Sridhar, Peter Yau Tak Ng, Chi Hung Cheng, Tat Chi Tsang, Matthew Sik Hon Tsui, Colin Alexander Graham, Timothy Hudson Rainer

Abstract

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.

Keywords: accident & emergency medicine; feasibility studies; infectious diseases; qualitative research; randomized controlled trial.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The stepped wedge design for the NEWS-1 pilot randomised controlled trial. ED, emergency department; NEWS, National Early Warning Score.
Figure 2
Figure 2
Cluster and patient participant flow chart in the NEWS-1 pilot stepped wedge randomised controlled trial. NEWS, National Early Warning Score.

References

    1. Adhikari NKJ, Fowler RA, Bhagwanjee S, et al. . Critical care and the global burden of critical illness in adults. Lancet 2010;376:1339–46. 10.1016/S0140-6736(10)60446-1
    1. Iwashyna TJ, Ely EW, Smith DM, et al. . Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA 2010;304:1787–94. 10.1001/jama.2010.1553
    1. Rudd KE, Johnson SC, Agesa KM, et al. . Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet 2020;395:200–11. 10.1016/S0140-6736(19)32989-7
    1. Liu YZ, Chu R, Lee A, et al. . A surveillance method to identify patients with sepsis from electronic health records in Hong Kong: A single centre retrospective study. BMC Infect Dis 2020;20:652. 10.1186/s12879-020-05330-x
    1. Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence 2014;5:4–11. 10.4161/viru.27372
    1. Dellinger RP, Carlet JM, Masur H, et al. . Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med 2004;32:858–73. 10.1097/01.CCM.0000117317.18092.E4
    1. Levy MM, Pronovost PJ, Dellinger RP, et al. . Sepsis change bundles: converting guidelines into meaningful change in behavior and clinical outcome. Crit Care Med 2004;32:S595–7. 10.1097/01.ccm.0000147016.53607.c4
    1. Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 Update. Crit Care Med 2018;46:997–1000. 10.1097/CCM.0000000000003119
    1. Rhodes A, Phillips G, Beale R, et al. . The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med 2015;41:1620–8. 10.1007/s00134-015-3906-y
    1. Barbash IJ, Davis B, Kahn JM. National Performance on the Medicare SEP-1 Sepsis Quality Measure. Crit Care Med 2019;47:1026–32. 10.1097/CCM.0000000000003613
    1. Kopczynska M, Unwin H, Pugh RJ, et al. . Four consecutive yearly point-prevalence studies in Wales indicate lack of improvement in sepsis care on the wards. Sci Rep 2021;11:16222. 10.1038/s41598-021-95648-6
    1. Venkatesh AK, Slesinger T, Whittle J, et al. . Preliminary Performance on the New CMS Sepsis-1 National Quality Measure: Early Insights From the Emergency Quality Network (E-QUAL). Ann Emerg Med 2018;71:10–5. 10.1016/j.annemergmed.2017.06.032
    1. Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Shatin, Hong Kong, Hung KK, Lam RP, et al. . Cross-sectional study on emergency department management of sepsis. Hong Kong Med J 2018;60:571–8. 10.12809/hkmj177149
    1. Reich EN, Then KL, Rankin JA. Barriers to Clinical Practice Guideline Implementation for Septic Patients in the Emergency Department. J Emerg Nurs 2018;44:552–62. 10.1016/j.jen.2018.04.004
    1. Carlbom DJ, Rubenfeld GD. Barriers to implementing protocol-based sepsis resuscitation in the emergency department--results of a national survey. Crit Care Med 2007;35:2525–32. 10.1097/01.ccm.0000298122.49245.d7
    1. Turi SK, Von Ah D. Implementation of early goal-directed therapy for septic patients in the emergency department: a review of the literature. J Emerg Nurs 2013;39:13–9. 10.1016/j.jen.2011.06.006
    1. Seymour CW, Liu VX, Iwashyna TJ, et al. . Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016;315:762–74. 10.1001/jama.2016.0288
    1. Maitra S, Som A, Bhattacharjee S. Accuracy of quick Sequential Organ Failure Assessment (qSOFA) score and systemic inflammatory response syndrome (SIRS) criteria for predicting mortality in hospitalized patients with suspected infection: a meta-analysis of observational studies. Clin Microbiol Infect 2018;24:1123–9. 10.1016/j.cmi.2018.03.032
    1. Marik PE, Farkas JD, Spiegel R, et al. . POINT: Should the Surviving Sepsis Campaign Guidelines Be Retired? Yes. Chest 2019;155:12–4. 10.1016/j.chest.2018.10.008
    1. Pepper DJ, Sun J, Cui X, et al. . Antibiotic- and Fluid-Focused Bundles Potentially Improve Sepsis Management, but High-Quality Evidence Is Lacking for the Specificity Required in the Centers for Medicare and Medicaid Service’s Sepsis Bundle (SEP-1). Crit Care Med 2019;47:1290–300. 10.1097/CCM.0000000000003892
    1. Levy MM, Rhodes A, Phillips GS, et al. . Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med 2015;43:3–12. 10.1097/CCM.0000000000000723
    1. Townsend SR, Phillips GS, Duseja R, et al. . Effects of Compliance With the Early Management Bundle (SEP-1) on Mortality Changes Among Medicare Beneficiaries With Sepsis. CHEST 2022;161:392–406. 10.1016/j.chest.2021.07.2167
    1. Leisman DE, Doerfler ME, Ward MF, et al. . Survival Benefit and Cost Savings From Compliance With a Simplified 3-Hour Sepsis Bundle in a Series of Prospective, Multisite, Observational Cohorts. Crit Care Med 2017;45:395–406. 10.1097/CCM.0000000000002184
    1. Tarrant C, O’Donnell B, Martin G, et al. . A complex endeavour: an ethnographic study of the implementation of the Sepsis Six clinical care bundle. Implementation Sci 2016;11:149. 10.1186/s13012-016-0518-z
    1. Mellhammar L, Linder A, Tverring J, et al. . NEWS2 is Superior to qSOFA in Detecting Sepsis with Organ Dysfunction in the Emergency Department. J Clin Med 2019;8:1128. 10.3390/jcm8081128
    1. Usman OA, Usman AA, Ward MA. Comparison of SIRS, qSOFA, and NEWS for the early identification of sepsis in the Emergency Department. Am J Emerg Med 2019;37:1490–7. 10.1016/j.ajem.2018.10.058
    1. Durr D, Niemi T, Despraz J, et al. . National Early Warning Score (NEWS) Outperforms Quick Sepsis-Related Organ Failure (qSOFA) Score for Early Detection of Sepsis in the Emergency Department. Antibiotics (Basel) 2022;11:1518. 10.3390/antibiotics11111518
    1. Churpek MM, Snyder A, Han X, et al. . Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med 2017;195:906–11. 10.1164/rccm.201604-0854OC
    1. Sabir L, Ramlakhan S, Goodacre S. Comparison of qSOFA and Hospital Early Warning Scores for prognosis in suspected sepsis in emergency department patients: a systematic review. Emerg Med J 2022;39:284–94. 10.1136/emermed-2020-210416
    1. Graham CA, Leung LY, Lo RSL, et al. . NEWS and qSIRS superior to qSOFA in the prediction of 30-day mortality in emergency department patients in Hong Kong. Ann Med 2020;52:403–12. 10.1080/07853890.2020.1782462
    1. Royal College of Physicians . NHS England approves use of National Early Warning Score (NEWS) 2 to improve detection of acutely ill patients, Available:
    1. Copas AJ, Lewis JJ, Thompson JA, et al. . Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials 2015;16:352. 10.1186/s13063-015-0842-7
    1. Ho PL, Wu TC, Chao DVK, et al. . Reducing bacterial resistance with IMPACT, 5th edn. Hong Kong, 2017.
    1. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients’ care. Lancet 2003;362:1225–30. 10.1016/S0140-6736(03)14546-1
    1. Bentley J, Henderson S, Thakore S, et al. . Seeking Sepsis in the Emergency Department- Identifying Barriers to Delivery of the Sepsis 6. BMJ Qual Improv Rep 2016;5:u206760.w3983. 10.1136/bmjquality.u206760.w3983
    1. Wozniak J, Lei Y, Dargin J. The effect of providing clinical performance feedback on compliance with sepsis bundles in the emergency department. Am J Emerg Med 2017;35:1772–3. 10.1016/j.ajem.2017.05.018
    1. Nguyen HB, Corbett SW, Steele R, et al. . Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med 2007;35:1105–12. 10.1097/01.CCM.0000259463.33848.3D
    1. Pinnington S, Atterton B, Ingleby S. Making the journey safe: recognising and responding to severe sepsis in accident and emergency. BMJ Qual Improv Rep 2016;5:u210706.w4335. 10.1136/bmjquality.u210706.w4335
    1. Sungkar Y, Considine J, Hutchinson A. Implementation of guidelines for sepsis management in emergency departments: A systematic review. Australas Emerg Care 2018;21:111–20. 10.1016/j.auec.2018.10.003
    1. Damiani E, Donati A, Serafini G, et al. . Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One 2015;10:e0125827. 10.1371/journal.pone.0125827
    1. Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci 2012;7:37. 10.1186/1748-5908-7-37
    1. Roberts N, Hooper G, Lorencatto F, et al. . Barriers and facilitators towards implementing the Sepsis Six care bundle (BLISS-1): a mixed methods investigation using the theoretical domains framework. Scand J Trauma Resusc Emerg Med 2017;25:96. 10.1186/s13049-017-0437-2
    1. Steinmo SH, Michie S, Fuller C, et al. . Bridging the gap between pragmatic intervention design and theory: using behavioural science tools to modify an existing quality improvement programme to implement “Sepsis Six.” Implement Sci 2016;11:14. 10.1186/s13012-016-0376-8
    1. Steinmo S, Fuller C, Stone SP, et al. . Characterising an implementation intervention in terms of behaviour change techniques and theory: the “Sepsis Six” clinical care bundle. Implement Sci 2015;10:111. 10.1186/s13012-015-0300-7
    1. Albrecht L, Archibald M, Arseneau D, et al. . Development of a checklist to assess the quality of reporting of knowledge translation interventions using the Workgroup for Intervention Development and Evaluation Research (WIDER) recommendations. Implement Sci 2013;8:52. 10.1186/1748-5908-8-52
    1. Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci 2013;8:139. 10.1186/1748-5908-8-139
    1. Michie S, Richardson M, Johnston M, et al. . The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46:81–95. 10.1007/s12160-013-9486-6
    1. Powell BJ, McMillen JC, Proctor EK, et al. . A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev 2012;69:123–57. 10.1177/1077558711430690
    1. Mazza D, Bairstow P, Buchan H, et al. . Refining a taxonomy for guideline implementation: results of an exercise in abstract classification. Implement Sci 2013;8:32. 10.1186/1748-5908-8-32
    1. Cochrane Effective Practice and Organisation of Care Review Group . Data Collection Checklist. Ontario: Institute of Population Health. University of Ottawa, 2011.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health 1999;89:1322–7. 10.2105/ajph.89.9.1322
    1. Creswell JW. Qualitative inquiry and research design: Choosing among five traditions. Thousand Oaks, CA: Sage, 1998.
    1. Glaser BG, Strauss AL, Strutzel E. The Discovery of Grounded Theory; Strategies for Qualitative Research. Nursing Research 1968;17:364. 10.1097/00006199-196807000-00014
    1. Pinnock H, Barwick M, Carpenter CR, et al. . Standards for Reporting Implementation Studies (StaRI) Statement. BMJ 2017;356:i6795. 10.1136/bmj.i6795
    1. Hemming K, Taljaard M, McKenzie JE, et al. . Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ 2018;363:k1614. 10.1136/bmj.k1614
    1. Eldridge SM, Chan CL, Campbell MJ, et al. . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:i5239. 10.1136/bmj.i5239
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349–57. 10.1093/intqhc/mzm042
    1. Evans L, Rhodes A, Alhazzani W, et al. . Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med 2021;49:e1063–143. 10.1097/CCM.0000000000005337

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