'To wait or not to wait':lessons from running a wait-list controlled trial (ELSA) of a volunteer befriending service at the end of life within NHS, hospice and voluntary sectors

摘要

Background: Many innovations in palliative care are implemented without robust understanding of their effect. Trials are underused as they can be considered ethically and pragmatically challenging. Wait-list designs show promise as they enable all participants to receive the intervention, but with the rigour of a controlled trial. Aim: To provide recommendations on running wait-list trials in partnership with lay researchers within the hospice and voluntary sectors. Methods: A wait-list controlled trial testing volunteer delivered social action befriending services across 11 hospice, charity and NHS sites. Many non-clinical staff are responsible for site trial management and informed consent procedures, prepared with innovative face to face role play workshops. Participants are estimated to be in their last year of life, randomly allocated to receive the befriending intervention immediately or after a four week wait. Data collection at baseline, 4, 8 weeks: WHO QOL BREF, Loneliness scale, mMOS-SS, social networks. Intention to treat analysis includes fitting a linear mixed effect model to each outcome variable at 4, 8 and 12 weeks. ISRCTN 12929812 Results: Participants (currently n=117, recruitment commenced 6/15, completes 12/15) are currently at all trial stages. Methodological challenges centre on ‘the wait’. Initiation issues include acknowledging site staff design concerns and involving them in developing the protocol and documentation. Ongoing ‘wait’ issues involve providing support to address informed consent concerns and understanding trial procedures, addressing disappointment of ‘the wait’ allocation, allocating volunteers in a timely fashion, and the impact this has on understanding effect for this design. Conclusions: It is possible to run a rigorous and ethical wait-list trial in partnership with non-clinical site staff and volunteers. Key considerations include assessment of the wait period and data collection timing, understanding providing a service in the context of a trial, and clear responsive communications to support staff.