Working with non-clinical staff to deliver research:lessons from running a wait-list controlled trial (ELSA) of a volunteer befriending service towards the end of life

摘要

Background: Many palliative care services involve nonclinical staff such as volunteers and administrative staff, and research in these settings should involve them as active research partners. We provide recommendations on involving these people in research, learning from a wait list trial of a volunteer provided befriending intervention. Methods: A wait-list controlled trial investigating volunteer delivered befriending services across 11 sites in the UK. Non-clinical staff are responsible for site trial management and informed consent procedures. 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: Training for this role includes innovative face to face role play workshops, standard Good Clinical Practice education, and face to face and virtual site visits to check procedural compliance and address issues. Trial initiation matters include acknowledging staff concerns about trial design and involving them trial protocol development, documentation and research procedures. Areas that required acknowledgement and response during the trial include providing support to address issues of informed consent and eligibility, understanding the impact of the ‘wait’ allocation on participants (n=145), staff and volunteers, and integrating volunteer management and feedback into trial procedures. 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