Table 1 Site training content and delivery
Section number and content | Content (recruitment and consent related content in italic text) | Aim/key message (recruitment- and consent-related content in bold text) | Method of delivery (interactive element in bold text) | Typical length (mins) | Who delivered the session? |
|---|---|---|---|---|---|
1. Site initiation evaluation questionnaire | Description of site evaluation aims How and when to complete Part A and Part B Invitation to complete Part A before the opening presentation | Methods for site initiation evaluation To highlight aims, anonymity of participation and implied consent To provide an opportunity for questions | One-to-one or small group discussion as practitioners arrived | 5 | Consent study team or trial co-ordinator |
2. Opening presentation | Rationale and trial aims and approach to consent Introduction to the trial team | To highlight the significance of the trial, key aspects including trial interventions and approach to consent Encourage practitioner engagement | PowerPoint presentation | 15–20 | Trial co-ordinator/ consultant/research nurse |
3. Protocol overview including sample handling | Study endpoints, inclusion and exclusion criteria Protocol for staff Sample processing procedures | To outline key aspects of the protocol to ensure that it was followed in full including follow-up outside of the ED for consent procedures | PowerPoint presentation, question and answer session | 15–20 | Trial co-ordinator |
4. ED essentials | Screening and randomisation Treatment administration and accountability Case Report Form (CRF) completion Brief overview of approach to recruitment and consent (RWPC) | To consider the patient pathway, randomisation and intervention administration in the ED To provide practitioners with guidance on addressing parents’ trial-related questions during resuscitation | PowerPoint Presentation, video (covering screening, randomisation and intervention administration) and real-time simulation of screening, randomisation and intervention administration and question and answer session | 60 | Trial co-ordinator/ consultant/research nurse |
5. Research without prior consent (deferred consent) | Pre-trial research findings and related research/guidance [7, 11] Approach to recruitment and consent in EcLiPSE .Overview of forms including Patient information sheets and consent forms | To provide evidence that describes how parents support the trial and research without prior consent To guide practitioners on when to approach and discuss RWPC with parents, including what should happen in the situation when a child has died after entry into the trial | PowerPoint presentation – RWPC scenario video base on pre-trial research findings Question and answer session specific to recruitment and consent | 60–90 | Consent study team member or trial co-ordinator |
6. Safety reporting and monitoring | Definitions of adverse events etc. and process of reporting (including forms to use) Guidance for CRF completion | To guide practitioners on how to complete AE forms and report AEs To provide practitioners with data protection knowledge, monitoring visits information, PI obligations and document storage and archiving knowledge | PowerPoint presentation, question and answer session | 15 | Trial co-ordinator |
7. Next steps and question and answer | Outline of trial progress and expected site opening Description of how training should be rolled out to all staff on a regular basis | Opportunity for questions on any issue including rolling out of training | Group discussion | 15–20 | Led by trial co-ordinator, questions answered by all team members present |
8. Completion of Part B site evaluation questionnaire | Reminder to complete Part B before leaving the session | Completion of site evaluation questionnaire (Part B) | Invitation to complete questionnaire and leave for collection before leaving the room | 5 | Consent study team or trial co-ordinator |