Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Area of Science:

• Clinical Trials
• Informed Consent
• Patient Engagement

Background:

• Cluster randomized crossover trials present challenges in selecting appropriate consent models.
• Traditional informed consent may not be suitable for all trial designs.
• Patient advisors were engaged to address consent model dilemmas.

Purpose of the Study:

• To describe the experience of engaging patient advisors in identifying an optimal consent model for the PREP-IT trials.
• To examine surrogate measures of success for the chosen consent model.
• To determine the most suitable consent model for cluster randomized crossover trials.

Main Methods:

• Two multi-center cluster randomized crossover trials (PREP-IT) involved patient advisors and stakeholders.
• Regular meetings facilitated consensus on trial design, including the consent model.
• Patient advisors offered insights into participant reception and impact of design decisions.

Main Results:

• A deferred consent model was agreed upon, allowing consent post-surgery and pre-data collection.
• The PREP-IT trials achieved a consent rate of 80.7%.
• Participant withdrawal of consent was low at 0.67%.

Conclusions:

• The involvement of patient advisors in developing an optimal consent model was successful.
• The deferred consent model proved effective in the PREP-IT trials.
• Patient advisor engagement is recommended for large trials where traditional consent is suboptimal.