While explanatory trials serve to confirm a physiological or clinical hypothesis, the purpose of pragmatic trials is to inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. To design this pragmatic trial we have used the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) guidance, a tool containing nine domains reflecting trial design decisions that determine that trial’s position on the continuum from pragmatic to explanatory.

Fast-track RCTs have been specifically developed and used in palliative care research. They compare an intervention group against a control group until the primary endpoint is measured (i.e., 6 months in our study. After this period, the control group is also offered the intervention. The design is adapted from a ‘wait-list’ design (sometimes called a deferred entry or delayed intervention trial) but is called fast-track as patients are not on waiting lists and because the service is usually not offered to them at all. An important advantage of fast-track RCTs is that all eligible participants can receive the intervention, while the RCT remains rigorously controlled. This design can also help counter patients’ and families’ reluctance to be randomised to a control group that is not receiving a service. It can be used with patients with longer or shorter (i.e. several weeks) survival periods.