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Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT · Additional information

Additional information

CC BY 4.0 · National Institute for Health and Care Research · approximately 6 min read

Contributions of authors

Helen Snooks (https://orcid.org/0000-0003-0173-8843) (Professor of Health Services Research at Swansea University), chief investigator, led the development of the research question and study design, was responsible for trial delivery and conduct, led the drafting and editing of the final report, contributed to the writing of the report and approved the final version.

Jonathan Benger (https://orcid.org/0000-0001-6131-0916) (Professor of Emergency Care in the School of Health and Social Wellbeing at the University of the West of England, Bristol), co-applicant, contributed to the study design, protocol development and delivery of the trial at the Bristol Royal Infirmary, contributed to the writing of the report and approved the final version.

Fiona Bell (https://orcid.org/0000-0003-4503-1903) (Head of Research at Yorkshire Ambulance Service), principal investigator for Yorkshire Ambulance Service, contributed to the writing of the report and approved the final version.

Sarah Black (https://orcid.org/0000-0001-6678-7502) (Head of Research, Audit and Quality Improvement at South Western Ambulance Service NHS Foundation Trust) co-applicant, principal investigator for South Western Ambulance Service NHS Foundation Trust, contributed to the study design, supported the delivery of the trial at this site, contributed to the writing of the report and approved the final version.

Simon Dixon (https://orcid.org/0000-0001-7394-7009) (Health Economist based at the University of Sheffield) wrote the analysis plan for the health economic evaluation, analysed health economics data and led the drafting of the health economics chapter, contributed to the writing of the report and approved the final version.

Helena Emery (https://orcid.org/0000-0003-1890-4254) (Research Officer, Swansea University), project manager; co-ordinated the drafting and editing of final report, contributed to the writing of the report and approved the final version.

Bridie Angela Evans (https://orcid.org/0000-0003-0293-0888) (Research Officer, Swansea University), co-applicant, public and patient involvement lead, led the writing of the public involvement chapter, contributed to the writing of the report and approved the final version.

Gordon Fuller (https://orcid.org/0000-0001-8532-3500) (Consultant in emergency medicine and a NIHR fellow in health data science), co-applicant, contributed to the writing of the report and approved the final version.

Rebecca Hoskins (https://orcid.org/0000-0001-7883-437X) (Consultant Nurse and Senior Lecturer in the School of Health and Social Wellbeing at the University of the West of England, Bristol), co-applicant, principal investigator at the Bristol Royal Infirmary, contributed to the writing of the report and approved the final version.

Jane Hughes (https://orcid.org/0000-0003-1389-3402) (Site Researcher based at Sheffield University), service user involvement lead and qualitative support. Led writing of the service user chapter, contributed to the writing of the report and approved the final version.

Jenna Jones (https://orcid.org/0000-0002-1280-4941) (Research Officer and GP Registrar in Swansea Bay University Health Board), previous research manager, co-led the writing of the final report, contributed to the writing of the report and approved the final version.

Matthew Jones (https://orcid.org/0000-0002-6974-8725) (Research Officer at Swansea University and Psychotherapist), co-applicant, previous research manager, led the writing of the study protocol, contributed to the writing of the report and approved the final version.

Sasha Johnston (https://orcid.org/0000-0002-9904-8834) (Health Education England Clinical Fellow (Mental Health) and Research Paramedic with South Western Ambulance Service NHS Foundation Trust), PRSO for principal investigator for South Western Ambulance Service NHS Foundation Trust, contributed to the writing of the report and approved the final version.

Jaqui Long (https://orcid.org/0000-0002-6889-6195) (Researcher, Sheffield University) undertook some of the analysis for both of the qualitative chapters, contributed to writing the qualitative chapters, contributed to the writing of the report and approved the final version.

Chris Moore (https://orcid.org/0000-0002-2192-3002) (Head of Medicines Management and Principal Investigator for Welsh Ambulance Services NHS Trust), co-applicant, contributed to the writing of the report and approved the final version.

Rakshita Parab (https://orcid.org/0000-0003-1822-657X) (Research Officer at Swansea University) led the RCT recruitment data analysis, drafted chapter related to epidemiology and discriminant function, contributed to the writing of the report and approved the final version.

Richard Pilbery (https://orcid.org/0000-0002-5797-9788) (Research data analyst at Yorkshire Ambulance Service NHS Trust), PRSO for Yorkshire Ambulance Service NHS Trust, contributed to the writing of the report and approved the final version.

Fiona C Sampson (https://orcid.org/0000-0003-2321-0302) (Site Researcher, Sheffield University), service provider involvement lead and qualitative support, led writing of the service provider data chapter, contributed to the writing of the report and approved the final version.

Alan Watkins (https://orcid.org/0000-0003-3804-1943) (Professor of statistics at Swansea University), senior statistician, developed analysis plan, discriminant function and analysed data. Led draft of epidemiology and discriminant function chapter, contributed to the writing of the report and approved the final version.

Acknowledgements

This study was only possible thanks to the expertise and commitment of a wide range of people and organisations. Although we specifically acknowledge the following parties, we would like to extend our thanks to all of those who supported this work. All the participating hospitals, ASs and their staff.All patients and stakeholders who participated in the trial.NIHR HTA for funding and then supporting this research throughout.Anne Surman, Daniel Holohan, Neil Jenkinson and Hayley Dash for administrative support.Members of our DMC: Ranjit Lall (Chair), Andy Rosser, Dalya Marks and Matthew Reed.Members of our TSC: Kathy Rowan (Chair), Derin Omole, Ben Carter, Elwyn Thomas, Ian Mursell, Andrew McAuley and John Ryan.Our patient and public representatives: Jackie McCarthy and Rosita Wilkins.The SAIL Databank team at Swansea University.A special thanks to Jake Alhiliali, Penny Buykx, Timothy Driscoll, Adrian Edwards, Christopher Evans, Steve Goodacre, Kelly Hird, Ann John, Barbara Lawrence, Rosanna Oretti, Emma Parry, Robin Roop and Paul Williams for their support throughout the project.

Patient data statement

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives. You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Data-sharing statement

TIME data within SAIL is securely stored within the Databank. Applications to access data held within the SAIL Databank require approval following independent review by their Information Governance Review Panel (IGRP), and are subject to SAIL’s terms, conditions and data disclosure and dissemination policies and procedures. TIME data within the SAIL Databank are held in compliance with its data retention, archiving and data destruction policies. All other queries should be addressed to the Corresponding author.

Ethics statement

The TIME study was approved by the Health Research Authority on 8 January 2019 with a favourable opinion received from the Research Ethics Committee (reference number: 18/WA/0337) on 16 October 2018.

Information governance statement

Swansea University is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679.

Under the Data Protection legislation, Swansea University is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here: https://www.swansea.ac.uk/aboutus/compliance/data-protection/.

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/YNRC8249.

Primary conflicts of interest: Alan Watkins declares his role as a member of the NIHR HS&DR Funding Committee, 2018–present. Helen Snooks declares her role as a member of the NIHR HTA & EME Editorial Board, 2015–present. Swansea University is the study sponsor. The protocol is available at https://doi.org/10.1186/s40814-020-00626-w.

Publication

Snooks HA, Jones JK, Bell FB, Benger JR, Black SL, Dixon S, et al. Take-home naloxone administered in emergency settings: feasibility of intervention implementation in a cluster randomized trial. BMC Emerg Med 2024;24(1):155. https://doi.org/10.1186/s12873-024-01061-3

Disclaimers

This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.

← References

Attribution. Helen Snooks; Jonathan Benger; Fiona Bell; Sarah Black; Simon Dixon; Helena Emery et al. (2024). Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT. National Institute for Health and Care Research. Copyright © 2024 Snooks et al. Licensed under CC BY 4.0. NCBI Bookshelf NBK608691. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.

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