23 - The ENVISION study: Creating a values-oriented platform for informed consent.

Background:  Informed consent is often seen as burdensome because forms are long and challenging to read, and researchers may focus on reviewing complex consent language rather than supporting decision-making. The ENVISION (ENgaging with Values to Inform research deciSIONs) study is evaluating a values-oriented platform aiming to improve the informed consent process.

Methods:  The values-oriented platform (a digital tool and structured consent discussion) is being developed for a clinical trial comparing antibiotic regimens to treat pulmonary exacerbations in people with cystic fibrosis. Booster Shot Media, a health-focused creative company, is designing a novel digital consent tool to support research teams in guiding each person to make an individualized decision about participation based on their values. We are also developing training around consent communication and shared decision-making to align with the Cystic Fibrosis Foundation (CFF) Partnership Enhancement Program. The ENVISION study relies on active involvement of a steering committee representing expertise in a variety of disciplines (IRB professionals, clinicians, CF community members, bioethics scholars, and decision scientists, implementation scientists and health communications scholars). We also created working groups, which include members of the ENVISION and clinical trial research teams, steering committee members and CFF staff. Working groups focus on targeted activities including consent document revision, Spanish language content, communication training for decision making, and stakeholder engagement. These key groups will collaboratively refine the values-oriented platform.

Results:  Using the clinical trial approved consent document, we created a 2-page key information section and a more detailed information section in an iterative process. From this draft, Booster Shot Media created a prototype digital consent tool in January 2024. A novel feature of the digital tool is including reasons why some people may or may not join to encourage people to consider how their decisions align with their values. Feedback on the prototype was solicited from the clinical trial team, steering committee, and consent working group about design and experience, text, illustrations, and audio style. The study team shared the feedback with the Booster Shot Media team, and a revised version is expected in the summer of 2024. The communication working group has developed the RIVER (Relationships, Information, Values, Engagement, Reflection and Resolution) framework for research team members to guide their approach to supporting values-oriented decision making among prospective participants.

Limitations: It is unclear how this values-oriented platform will be received. To address this, we will conduct focus groups with past trial participants, research teams, and IRB members to gather feedback on the digital consent tool and consent communication approach. We will implement the revised values-oriented platform in the clinical trial and continue gathering feedback from participants and research teams.

Discussion:  The ENVISION study experience demonstrates recognition among clinical researchers, scholars, and patient communities that a participant-centered approach focused on key content and decision making can enhance the informed consent process. Preliminary feedback on the digital consent tool has been informative as we refine the tool. Implementation of a novel, values-oriented platform requires strategic and detailed planning, in combination with input from all sectors of the CF community and careful listening and responsiveness from the ENVISION study team. Opportunities to engage with research teams have been invaluable to this effort and key to the success of this approach in the future.