Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial

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Abstract

Background

Key challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials.

Methods

A mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate.

Results

A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target.

Conclusions

Successful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.

Related collections

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Author and article information

Journal

Journal ID (nlm-ta): Emerg Med J

Journal ID (iso-abbrev): Emerg Med J

Journal ID (hwp): emermed

Journal ID (publisher-id): emj

Title: Emergency Medicine Journal : EMJ

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Print): 1472-0205

ISSN (Electronic): 1472-0213

Publication date (Print): March 2021

Publication date (Electronic): 13 October 2020

Volume: 38

Issue: 3

Pages: 191-197

Affiliations

[1 ] departmentInstitute of Population Health & Society , University of Liverpool , Liverpool, UK

[2 ] departmentEmergency Department , Bristol Royal Children's Hospital , Bristol, UK

[3 ] departmentFaculty of Health and Applied Sciences , University of the West of England , Bristol, UK

[4 ] departmentLiverpool Clinical Trials Centre , University of Liverpool , Liverpool, UK

[5 ] departmentEmergency Department , Alder Hey Children's NHS Foundation Trust , Liverpool, Merseyside, UK

[6 ] departmentDepartment of Neurology , Alder Hey Children's NHS Foundation Trust , Liverpool, Merseyside, UK

Author notes

[Correspondence to ] Dr Kerry Woolfall, University of Liverpool, Liverpool L69 3BX, UK; k.woolfall@ 123456liverpool.ac.uk

Author information

Kerry Woolfall http://orcid.org/0000-0002-5726-5304

Article

Publisher ID: emermed-2020-209487

DOI: 10.1136/emermed-2020-209487

PMC ID: 7907583

PubMed ID: 33051276

SO-VID: 18fd82ea-b96d-4bc6-adcf-378726d9995a

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.