Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

Abstract

BackgroundRandomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial.MethodsThe TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members’ decision-making processes, when compared to standard participant information sheets alone.DiscussionThis study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.Trial registrationISRCTN registry: ISRCTN73136092 (doi:10.1186/ISRCTN73136092). Registered on 24 August 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1962-z) contains supplementary material, which is available to authorized users.

Patient and public involvement in a study of multimedia clinical trial information for children, young people and families

“…However, these documents have been criticized for being too long and complex (Caldwell et al, 2012;Tarnowski et al, 1990), and digital resources may be a promising alternative. The TRECA study, which consists of two phases, aims to develop and evaluate the use of digital, multimedia information resources (MMIs) provided to children, young people and their families when they are invited to take part in a health-care trial (Martin-Kerry et al, 2017). In Phase 1, prototype MMIs containing text, animations, video and pictures were developed with input from study participants including children, young people, families and health-care professionals, to ensure they met people's needs and preferences .…”

“…The impact of the MMIs will be assessed against three outcomes: (1) trial recruitment rates; (2) trial retention rates; and (3) the quality of decision-making by potential trial participants and (where relevant) their parents. Further information about the TRECA study is available in the published protocol (Martin-Kerry et al, 2017).…”

Intermittent antegrade warm-blood versus cold-blood cardioplegia in children undergoing open heart surgery: a protocol for a randomised controlled study (Thermic-3)

“…The Thermic-3 trial is embedding the Trials Engagement in Children and Adolescents (TRECA) SWAT. 13 This SWAT is investigating a novel method for recruitment to see whether providing children and their families with information about a trial through multimedia information (MMI) resources impacts on recruitment and retention rates and the quality of decision-making about trial participation. The MMI resources are websites with text, images, animations and videos about the Thermic-3 trial.…”

“…Prior to approach about the Thermic-3 trial, potential patients will be randomised (1:1:1) to one of the three TRECA SWAT groups: patient information leaflet (PIL), MMI or both PIL and MMI. 13 Parents/ guardians will be given either a PIL, MMI or both PIL and MMI. Patients aged over 7 years old will also be provided with a PIL, MMI or both PIL and MMI suitable to their age group (7-10 years, 11-15 years or 16 years and over).…”

Research barriers in children and young people with life-limiting conditions: a survey

“…Although focused on decision making for participation in healthcare trials involving CYP (the benefits and burden of participation are likely to differ for non-trial studies), a current trial is underway to evaluate how multimedia interventions, including textual, audio and visual information compare with written information. 32 The involvement of clinicians from the study design stage was viewed as important by CIs and should be considered a priority in future guidance. Taking a participatory approach to research, with health professionals involved early on, has been shown to be effective in prior palliative care research, 33 both in terms of the representativeness of the sample and positive perspective of health professionals when collecting the data.…”