The goal of the STRIDE Intervention piloting is to examine the STRIDE integrated intervention platform (eConsent, storytelling, and procedural videos) in the context of a real-world clinical trial workflow. The pilot testing will occur in two phases, with the first focused on content development and refinement, and the second focused on the consenting process utilizing the developed eConsent platform.
The STRIDE team recruited an active clinical trial at UAB to participate as our exemplar trial. The recruited clinical trial agreed to share their “live” consent document for review by STRIDE Community Investigators and research staff, as well as have an integrated eConsent platform built and shared with recruited UAB research assistants and community members for their input during the piloting phases.
During Phase 1 the exemplar clinical trial’s consent document was vetted through the UAB Community Investigators, UAB IRB representative, and STRIDE research staff for appropriate health literacy level, readability, and functionality with the intervention components.
A number of changes were instituted to simplify language, reorganize sections, and clarify the potential benefits of the research to future generations.
Platform Build and Troubleshooting
The exemplar consent document was translated into the STRIDE integrated intervention platform within the local UAB instance of REDCap.
Research Assistant Focus Group
The platform build with content was reviewed by seven UAB research assistants/research nurses (71% minorities) from diverse research backgrounds (e.g., Oncology, Neurology, Hypertension). Feedback, including impressions of videos, font sizing, scrolling features, and procedural videos, was shared with the respective Vanderbilt and University of Massachusetts STRIDE teams for appropriate modifications to intervention components.
Integration of eConsent Build into Real World Clinic Workflow
Two versions of the exemplar eConsent were developed, a version for remote reviewing in advance of a research appointment (utilizing avatar (aka eStaff)) and a version for the participant to review in the presence of a research assistant/nurse.
Phase 2 is planned in the third quarter of 2018 and will integrate enhancements from the first phase to improve the fidelity and feasibility of the intervention. Information gathered during this phase will help in the simulation and dissemination phases of the intervention.
Potential users will be asked to review the eConsent build both remotely and in-person during a “mock consent”. The purpose of this testing is to develop a list of best practices or recommendations when utilizing the STRIDE integrated intervention platform.