Dataset Information

Enhancing practitioners' confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training - a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study.

ABSTRACT:

Background

EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents' perspectives and research without prior consent (RWPC) guidance, we developed an interactive training package (including videos, simulation and question and answer sessions) and evaluated its dissemination and impact upon on practitioners' confidence in recruitment and consent.

Methods

Questionnaires were administered before and immediately after training followed by telephone interviews (mean 11?months later), focus groups (mean 14?months later) and an online questionnaire (8?months before trial closure).

Results

One hundred and twenty-five practitioners from 26/30 (87%) participating hospitals completed a questionnaire before and after training. We conducted 10 interviews and six focus groups (comprising 36 practitioners); 199 practitioners working in all recruiting hospitals completed the online questionnaire. Before training, practitioners were concerned about recruitment and consent. Confidence increased after training for explaining (all scale 0-5, 95% CIs above 0 and p values ConclusionsTraining improved practitioners' confidence in recruitment and RWPC. Our findings highlight the value of using parents' perspectives to inform training and to engage practitioners in trials that are at high risk of being too challenging to conduct.

SUBMITTER: Woolfall K

PROVIDER: S-EPMC6429745 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Enhancing practitioners' confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training - a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study.

Woolfall Kerry K Roper Louise L Humphreys Amy A Lyttle Mark D MD Messahel Shrouk S Lee Elizabeth E Noblet Joanne J Iyer Anand A Gamble Carrol C Hickey Helen H Rainford Naomi N Appleton Richard R

Trials 20190321 1

<h4>Background</h4>EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents' perspectives and research without prior consent (RWPC) guidance, we developed an interactive training packa ...[more]

PMID: 30898169

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Project description:BackgroundIn 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners' views and experiences of seeking deferred consent in this setting.MethodsAs part of a wider study investigating consent methods in paediatric emergency care trials (called CONNECT), a 20 item online questionnaire was sent by email inviting practitioners (doctors and nurses) who were involved in talking with families about children's and young people's (aged 0-16 years) participation in UK EC trials. To ensure those with and without experience of deferred consent were included, practitioners were sampled using a combination of purposive and snowball sampling methods. Simple descriptive statistics were used to analyse the quantitative data, whilst the constant comparative method was used to analyse qualitative data. Elements of a symbiotic empirical ethics approach was used to integrate empirical evidence and bioethical literature to explore the data and draw practice orientated conclusions.ResultsViews on deferred consent differed depending upon whether or not practitioners were experienced in this consent method. Practitioners who had no experience of deferred consent reported negative perceptions of this consent method; these practitioners were concerned about the impact that deferred consent would have upon the parent-practitioner relationship. In contrast, practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. Experienced practitioners also described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting.ConclusionsThe views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future paediatric EC trials; the design and ethical review of such trials should not solely be informed by the beliefs of those without experience of using deferred consent. Further research involving parents and children is required to inform practitioner training and normative guidance on the use and appropriateness of deferred consent in emergency settings.

Project description:There has been a drive towards increased digitalisation in healthcare. The aim was to provide a snapshot of current apps, instant messaging, and smartphone photography use in paediatric emergency care. A web-based self-report questionnaire was performed. Individual physicians working in paediatric emergency care recorded their personal practice. One hundred ninety-eight medical doctors completed the survey. Eight percent of respondents had access to institutional mobile devices to run medical apps. Eighty-six percent of respondents used medical apps on their personal mobile device, with 78% using Apple iOS devices. Forty-seven percent of respondents used formulary apps daily. Forty-nine percent of respondents had between 1-5 medical apps on their personal mobile device. Respondents who used medical apps had a total of 845 medical apps installed on their personal device, accounted for by 56 specific apps. The British National Formulary (BNF/BNFc) app was installed on the personal mobile device of 96% of respondents that use medical apps. Forty percent of respondents had patient confidentiality concerns when using medical apps. Thirty-eight percent of respondents have used consumer instant messaging services, 6% secure specialist messaging services, and 29% smartphone photography when seeking patient management advice. CONCLUSION: App use on the personal mobile devices, in the absence of access to institutional devices, was widespread, especially the use of a national formulary app. Instant messaging and smartphone photography were less common. A strategic decision has to be made to either provide staff with institutional devices or use software solutions to address data governance concerns when using personal devices. What is Known: • mHealth use by junior doctors and medical students is widespread. • Clinicians' use of instant messaging apps such as WhatsApp is the widespread in the UK and Ireland, in the absence of alternatives. What is New: • Personal mobile device use was widespread in the absence of alternatives, with the British National Formulary nearly universally downloaded to physicians' personal mobile devices. • A third of respondents used instant messaging and smartphone photography on their personal mobile device when seeking patient management advice from other teams in the absence of alternatives.

Dataset Information

Enhancing practitioners' confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training - a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study.

Background

Methods

Results

Publications

Enhancing practitioners' confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training - a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study.

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