Bilingual Decision Aids Aim to Strengthen Patient Engagement in Clinical Trials
A new clinical trials protocol lays out a structured effort to build and test two web-based decision aids designed for patient partners and investigators. The project is centered on improving patient engagement partnerships while also building capacity to address sex and gender knowledge gaps in trial conduct. Rather than treating engagement as an abstract ideal, the program turns it into a practical, testable intervention with a defined development pathway, bilingual translation, and staged usability and field evaluation.
The work is organized as a two-year program with sequential phases. Two decision aids were created in Phase 1, and the present protocol describes the next steps: refinement and translation, followed by alpha and usability testing, then beta and field testing. A key feature of the design is the use of patient-oriented research methods across every stage, with patient partners embedded throughout the program rather than added after the fact. In a setting where trial participation, communication, and shared decision-making often determine whether engagement succeeds or stalls, a tool that helps both patients and investigators navigate expectations could have direct operational value.
Phase-by-Phase Testing of a Patient and Investigator Toolset
The development process follows several established frameworks at once, including the International Patient Decision Aid Standards, User-Centred Design, the Ottawa Decision-Support Framework, and the Ottawa Model of Research Use. Each framework contributes a different piece of the architecture. Decision aid standards shape content quality and transparency; user-centered design keeps the interface anchored to actual users; decision-support theory addresses how people weigh options; and knowledge translation models guide adoption in real research settings. The result is not just a digital handout, but a deliberately engineered support tool meant to fit the realities of trial environments.
Phase 2A focuses on refinement and translation. The aids will be adapted and then translated into French, reflecting the multilingual setting of the planned testing. That step is more than a language exercise. In patient engagement work, access depends on comprehension, and comprehension depends on more than literal translation. Vocabulary, tone, and the framing of responsibilities can all affect whether a patient partner or investigator sees the tool as usable, credible, and relevant to their role.
Phase 2B moves into usability assessment through eight iterative cycles of semistructured interviews. Forty participants will be enrolled for this stage, evenly divided between 20 patient partners and 20 investigators. The interview structure is designed to identify friction points in the tools themselves: whether instructions are intuitive, whether content is too dense, whether the decision prompts align with the way people actually approach partnership in trials, and whether the interface supports rather than burdens use. Iterative testing matters here because design failures in web-based tools rarely appear in a single pass; they surface when real users interact with the material and expose ambiguity, duplication, or missing context.
Pragmatic Field Testing Will Compare Responses Across Language and Sex
Phase 3 will use a pragmatic pre/post pilot design for field or beta testing. Another purposive sample of 80 participants will be recruited, including 40 patients and 40 investigators, with equal representation of English-speaking and French-speaking participants and equal representation of men and women. The sampling strategy is intentionally balanced so the project can examine whether the aids function similarly across language groups and across sex. Since prior sex and gender differences in the utilization and effectiveness of decision aids have not been reported in this context, results from Phase 3 will be presented for the total sample and separately for men and women.
That analytic choice is clinically relevant. Decision aids do not operate in a vacuum; they work through perception, confidence, and willingness to engage. If a tool improves clarity for one subgroup but not another, the adoption pathway changes. If one language version is easier to navigate than the other, translation quality becomes a functional determinant of implementation, not a cosmetic feature. The protocol anticipates those possibilities by building them into the analysis plan from the start.
The emphasis on patient engagement also reflects a broader challenge in clinical research: trial success depends not only on recruitment and retention, but on whether participants and investigators share an understanding of roles, expectations, and decision points. Patient partners can improve the relevance of research questions and the legitimacy of study processes, while investigators can bring methodological rigor and operational discipline. A decision aid aimed at both groups tries to make that collaboration easier to initiate and easier to sustain.
The project will also evaluate the tools in an open-access web-based format. Accessibility is a meaningful feature in this context because it broadens the possibility of reuse across settings without requiring a proprietary platform or local infrastructure. Open access also fits the educational intent of the program, since the tools are meant to support learning as well as decision-making.
Ethics Approval, Consent, and Planned Dissemination
Ethics approval has already been secured from the University of Toronto. Informed consent will be obtained from participants before enrollment. The protocol also describes a broad dissemination plan that includes co-authored publications, conference presentations, educational national public forums, fact sheets and newsletters, social media sharing, and videos or webinars. Those channels suggest a project designed not only to generate academic output, but also to circulate the decision aids and the methods behind them to researchers, patient communities, and broader engagement networks.
The study remains a protocol, so no efficacy claims can be made at this stage. Its value lies in the design itself: a sequential, bilingual, patient-partnered development strategy with usability testing before field deployment. For clinical research teams trying to build stronger partnerships with patients, the key question will be whether the final tools are usable enough to support real engagement and robust enough to travel across languages, roles, and trial settings without losing clarity.