Promoting Accessibility in Clinical Trials (PRACTICALs): Development and pilot testing of an eLearning resource

RESEARCH AIM: The design and pilot evaluation of a handbook and online learning modules for researchers and ethics committees on improving the accessibility of clinical trials for people with physical and mental disabilities.

BACKGROUND: The Equality Act 2010 defines a person as disabled if they have: “a physical or mental impairment that has a substantial and long-term adverse effect on a person s ability to do normal daily activities.” The 2021 UK Census found that 18% of the population in England reported living with a disability (9.8 million people).

Participants with disabilities may be excluded from some trials by strict eligibility criteria, but they are also inadvertently excluded by poorly designed or inflexible trial protocols.

Designing trials that work for disabled people is critical to the success of research into long-term conditions and multiple co-morbidities, and vital to the generalisability of findings on the safety and efficacy of new interventions, and in ensuring fair and equal access to trial participation. Guidance on this is currently scarce.

OBJECTIVES: Analyse the accessibility of published trials Review existing guidance on the inclusion of disabled people in trials Develop a handbook on designing and reviewing the accessibility of trials Build eLearning modules on accessibility for researchers and ethics committees Pilot test our eLearning resource METHODS: In Work Package 1 we will address objectives 1 and 2, and: a) Analyse 30 published UK trial protocols (purposively sampled for a range of: intervention type, setting, trial design, disease area) using Disability Rights UK s disability access audit framework. b) Conduct a literature review of trial publications where participants have a severe disability, and relevant recruitment and retention research.

In Work Package 2, our findings will be used to design a handbook and e-learning modules for researchers and ethics committee members.

The eLearning module will deploy active adult learning techniques such as information presented in varied formats, self-reflection opportunities, short quizzes, and adaptive learning.

In Work Package 3, we will conduct a single-arm mixed-methods pilot evaluation of the e-learning module using the Kirkpatrick Model, with 60 researchers and ethics committee members.

Data collected using pre- and post-training questionnaires, within-module quizzes/self-reflection, learning analytics and a 3-month questionnaire will capture: learner characteristics, satisfaction, engagement, knowledge acquisition, and early application of knowledge in practice.

TIMELINES: Months 1-6: protocol analysis, literature review, handbook development Months 5-9: e-Learning build, ethical approval Months 10-17: recruitment, training delivery, data collection Months 15-19: analysis, publications, dissemination IMPACT/DISSEMINATION: Our resources will be designed to improve researcher knowledge, skills and attitudes around disability in the trial context.

We hypothesise that this will impact on trial design and lead to greater representation of disabled people in trials, therefore enhancing the generalisability of trial findings.

The pilot evaluation will help refine our resources and support the design of future investigations of the impact of this training on the inclusion of disabled people in trials.

At each step of the project, with our PPI representatives and stakeholders, we will consider the optimal dissemination strategy, including papers, conference presentations, and media content.