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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. A key barrier to paediatric trials is the high rates of patient (or parent) refusal to participate. It’s possible this could be reduced by improving the quality of information they receive about trial participation.

The printed information sheets that are currently used in most trials are often too long, technical and lacking in visual appeal. Multimedia information (MMI) resources involving text, audio, video and animations may better inform children and adolescents and their parents about trials, potentially leading to increased engagement in trials.

Link to project page: NIHR HS&DR - 14/21/21

What did the TRECA study find?

The main results paper can be accessed here.

Here's a short animated video summarising the results:

https://youtu.be/kAHVzcwIqB4

We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants were randomly allocated to receive multimedia-only (MMI), printed information-only (PIS), or combined MMI + PIS. We recorded the rates of recruitment and retention in each host trial. Potential participants were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to evaluate the information and their reasons for participation or non-participation. Odds ratios were calculated and combined in a meta-analysis.

Results

Data from 3/6 SWATs were combined in a meta-analysis (n = 1,758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation.

Conclusions

Providing multimedia information-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention.

MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.

MMI Development phase: the multimedia information was developed through extensive qualitative research, user testing and enhanced Patient and Parent Involvement (PPI). We have published the development phase studies, as well as three of the individual SWAT studies:

• TRECA Protocol paper: https://doi.org/10.1186/s13063-017-1962-z
• Two reports of the qualitative study: https://bmjopen.bmj.com/content/9/1/e023984 and https://doi.org/10.1177/13674935221109684
• User Testing study: https://doi.org/10.1177/1367493518807325
• Report of the TRECA PPI work: DOI https://doi.org/10.18546/RFA.04.1.05
• A paper on the challenges encountered in TRECA: https://doi.org/10.1186/s13063-019-3236-4 
• A ‘hypothetical trial’ looking at the acceptability of the MMIs: https://doi.org/10.1177/14653125211024250
• The SWAT set within the FORCE trial: https://doi:10.1136/bmjopen-2021-057508  
• The SWAT set within the Thermic-3 trial: https://f1000research.com/articles/11-340.

Example Multimedia Information

As an example, here is a summary of the multimedia websites that were developed and evaluated in the BAMP sub-study.