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Interventions to support patient decision making about taking part in health research: A systematic review
Jolyn Hersch1, Lauren O'Hara1, Ilona Juraskova2
1The University of Sydney, Faculty of Science, School of Psychology, Psycho-Oncology Co-operative Research Group (PoCoG), NSW, Australia; The University of Sydney, Faculty of Medicine and Health, School of Public Health, Sydney Health Literacy Lab, NSW, Australia.
Objectives:
An important, albeit challenging, aspect of conducting clinical research is achieving informed consent. We systematically reviewed the literature to characterise existing interventions designed to support communication and decision making about participating in health research.
Methods:
We searched five databases (1990-2025) for peer-reviewed studies about intervention development and/or evaluation, reporting data on acceptability and/or efficacy. Eligible interventions addressed decisions about research participation and aimed to improve decision quality by enabling adult patients to address their information needs (e.g., question prompt list) and/or incorporate their values into decision making (e.g., decision aid). We conducted a narrative synthesis to describe the interventions, summarising findings on their effects where applicable.
Results:
Eighteen studies met inclusion criteria. In seven studies, interventions targeted a specific clinical study; 11 covered clinical trials generally. Eight tools were printed; ten were digital, incorporating various interactive features. Four interventions addressed racial, ethnic, or cultural diversity. Thirteen papers cited relevant theories or frameworks that informed intervention development. Evidence from controlled studies (n = 11) showed that interventions generally increased knowledge, with little effect on participation rates.
Conclusions And Practice Implications:
This review highlights the potential utility of tools for patients considering health research participation, providing an overview of resources available and synthesising key principles for intervention developers. However, most interventions targeted decisions about participation in cancer clinical trials. Future interventions should address other clinical settings and research designs, and emerging areas like genomics and precision medicine. Digital technology can offer opportunities to tailor content, enhance interactivity, and optimise support for diverse communities.
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