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

A 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research. The overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR). We used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature. A total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR’s patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed ‘good’ usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation. Our digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada’s Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system. 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.

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