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Table 2 Objectives, action plan and criteria for progression to a full trial

From: CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial

Objectives Action plan Threshold for progression to definitive RCT
1 To refine the assessment and outcome measures to be used in any potential RCT Qualitative feedback will be collected from participants 2–4 months after the intervention, regarding the acceptability of the measures and will evaluate whether all of the intended information was captured  
2 To evaluate the acceptability of the manualised intervention (and potentially refine) An initial workshop with the Australian team was held (Nov 2015). Expert consensus workshop discussions led to refined trial processes, education package and resources [30] A detailed process is described in the study protocol clarifying the legal and regulatory framework for the practice In the feasibility study the simplest method is for lay carers to draw up medications only in immediate form; a full trial would be more appropriate if able to extend this to advance preparation and labelling
3 To evaluate the recruitment process Referral sites and referral sources Where participants heard about the study Number and speed of referrals received and time elapsed between initial contact made with the study team (for information and consent form) In the feasibility we have assumed 50% recruitment – we would say a full trial is not possible if recruitment falls < 30%
4 To estimate participant retention rate for the full RCT Retention rates will inform the refinement of the sample size calculation for any potential subsequent RCT Participant engagement will be monitored throughout the pilot trial In the feasibility we have assumed 50% retention – we would say a full trial is not possible if retention falls < 40%
5 To test the assessment and outcome measures for suitability, relevant change factors and acceptability to participants Data from the assessment process will be compared against raw data from the outcome measures to assess the outcome measures sensitivity to identifying participant change  
6 To identify acceptability and collection of relevant data to inform the data collection and analysis plan for implementation in the subsequent RCT A review will be completed of each outcome measure of levels of missing data and stability to ensure that the information collected will allow any future main analysis to be feasible and appropriate. Amendments can be suggested where appropriate to amend data collection for any potential future trial. The data available will also inform the details for the analysis plan of any potential full trial Carer Diary data items successfully completed (70%) Family MSAS-GDI successfully completed at bereavement visit (70%) QOLLTI-F successfully completed at 48-h intervals (70%)