CAPTIVATE

Consent for Adaptive Platform TrIals using abbreViATEd, patient-centered, modular audiovisual methods

Domain Lead Investigators

Domain Description

Objective

Develop a novel informed consent method within PRACTICAL and determine if this improves participant-perceived evaluations of the consent process, compared with standard informed consent processes.

Population All patients who screen eligible for possible enrolment in PRACTICAL will be able to participate in the CAPTIVATE consent domain at participating sites. If patients are unable to provide first person consent, their surrogate decision maker will be able to participate on their behalf.
Primary Endpoint The primary outcome will be participant-perceived evaluation of the consent process using a brief survey.
Design

CAPTIVATE is a multi-center, open-label, parallel-group SWAT evaluating novel consent methods for patients eligible for three large adaptive platform trials, including PRACTICAL. Patients will be randomly allocated to receive either a novel consent method using video and infographics, compared to the standard paper based informed consent method.