Feasibility of a Study Within a Trial to evaluate a decision support intervention for families deciding about research on behalf of adults lacking capacity to consent (CONSULT SWAT).

ABSTRACT: Trials involving adults who lack capacity to consent can be challenging, partly due to the involvement of 'proxy' decision-makers. This is usually a family member, who advises the researchers about the person's wishes. Families can find decision making difficult and some experience a decisional burden. Following the development of a decision aid for family members making trial participation decisions, we are conducting a mixed-methods randomised Study Within a Trial (SWAT) to evaluate its (cost-)effectiveness. This paper reports the feasibility stage conducted in one host study to inform delivery of the main SWAT. Family members approached to act as a consultee for the host study were randomised 1:1 to receive the decision aid booklet alongside standard study information (intervention), or

SUBMITTER: Shepherd V 

PROVIDER: S-EPMC12382041 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature