The TRECA study: TRials Engagement in Children and Adolescents
Randomised controlled trials are the best way to determine the effectiveness and safety of healthcare interventions. However, there are very few healthcare trials involving children and adolescents meaning that important clinical decisions are based on evidence extrapolated from trials involving adults. A key barrier to paediatric trials is the high rates of patient (or parent) refusal to participate, though it is possible that this could be reduced by improving the quality of information that they receive about trial participation. The printed information sheets which are currently used in most trials have been widely criticised for being too long, technical and lacking in visual appeal. Multimedia information (MMI) resources involving text, audio, video and animations have the potential to better inform children and adolescents and their parents about trials, potentially leading to their increased engagement in healthcare trials.
Link to project page: NIHR HS&DR - 14/21/21
What will TRECA do?
The TRECA study will be completed in two phases, over 2016 – 2018:
Phase 1 – Development
- The research team will develop two MMIs (one for adolescents and their parents; and another for younger children and their parents) for use when children and adolescents are asked to consider taking part in a healthcare trial. Both MMIs will contain generic trial information (e.g. on randomisation, study withdrawal) and information specific to an individual trial (e.g. its purpose, length, any additional hospital appointments for participants). The content of the MMIs will reflect the content found in a traditional participant information sheet.
- The MMI development will be influenced by the views of relevant stakeholders (i.e. children and adolescents with long-term conditions, parents, clinicians, etc). The MMIs will also be ‘user tested’ for their ability to inform patients/parents. This process will identify any parts of the MMI which are not understood by users and can be improved by the research team.
Phase 2 – Evaluation
- The MMIs will be embedded in six healthcare trials (known as host trials) which are recruiting children and adolescents.
- We will test the impact of the MMIs on decision making by comparing rates of trial recruitment (whether patients decide to participate) and retention (whether they stay on the trial) between participants who receive the standard participant information sheet alone; the MMIs alongside the satandard participant information sheets; and those who receive the MMI alone. We will also assess quality of decision-making by questionnaire.