Patient Engagement Partnerships in Clinical Trials: Development of Patient Partner and Investigator Decision Aids

The goal of this project was to improve sex/gender knowledge and help patients and investigators work together as partners in clinical trials. There were three phases to this project: Phase 1, search the literature to see what others had done; Phase 2, share the results of Phase 1 with key stakeholders to determine gaps, and develop tools to fill the gaps; and Phase 3, share the tools developed in Phase 2 with others to get feedback. We worked with Clinical Trials Ontario and other key stakeholders to make two decision aids—one for patients and one for investigators. The decision aids share sex/gender knowledge and information about patient-oriented research. Each decision aid has five parts: (1) Introduction (get the facts); (2) My Priorities (patient partner and investigator priorities); (3) Learn More (information on sex/gender and other resources to help patients and investigators work together); (4) My Readiness (comparing priorities with benefits and risks); and (5) My Decision (decision and next steps). Patients, investigators, and other key stakeholders really liked the decision aids and found them easy to move through, they had useful information, and they looked good. Comments included “I enjoyed that the decision aids were separated for patients and investigators”; “I liked it, it was user-friendly and easy to navigate”; and “there could be more interaction and aimed more for mobile devices”. These decision aids are the first to provide knowledge and support beyond the standard decision aids used for health decisions. Next steps include getting more feedback and using the decision aids in a laboratory and then in a real-life setting and see if people still like them.