Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial

DiscussionThis SWAT will generate the first evidence for recruitment interventions for trials involving adults lacking capacity to consent and add to knowledge about the use of decision support interventions in trial participation decisions. The SWAT will be embedded in a range of trials, and the heterogenous nature of the host trials, settings and populations involved will enable the intervention to be evaluated in a wide range of contexts. However, a pragmatic and flexible approach to conducting the SWAT is needed.Trial registrationThe SWAT is registered asSWAT #159 with the Northern Ireland Hub for Trials Methodology Research SWAT repository (registered 09.08.2020). Each host trial will be registered on a clinical trials registry.
Source: Trials - Category: Research Source Type: clinical trials