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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

BACKGROUND: Randomised 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...

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Autores principales: Martin-Kerry, Jacqueline, Bower, Peter, Young, Bridget, Graffy, Jonathan, Sheridan, Rebecca, Watt, Ian, Baines, Paul, Stones, Catherine, Preston, Jennifer, Higgins, Steven, Gamble, Carrol, Knapp, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5465557/
https://www.ncbi.nlm.nih.gov/pubmed/28595613
http://dx.doi.org/10.1186/s13063-017-1962-z
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author Martin-Kerry, Jacqueline
Bower, Peter
Young, Bridget
Graffy, Jonathan
Sheridan, Rebecca
Watt, Ian
Baines, Paul
Stones, Catherine
Preston, Jennifer
Higgins, Steven
Gamble, Carrol
Knapp, Peter
author_facet Martin-Kerry, Jacqueline
Bower, Peter
Young, Bridget
Graffy, Jonathan
Sheridan, Rebecca
Watt, Ian
Baines, Paul
Stones, Catherine
Preston, Jennifer
Higgins, Steven
Gamble, Carrol
Knapp, Peter
author_sort Martin-Kerry, Jacqueline
collection PubMed
description BACKGROUND: Randomised 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. METHODS: The 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. DISCUSSION: This 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 REGISTRATION: ISRCTN registry: ISRCTN73136092 (doi:10.1186/ISRCTN73136092). Registered on 24 August 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1962-z) contains supplementary material, which is available to authorized users.
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spelling pubmed-54655572017-06-09 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 Martin-Kerry, Jacqueline Bower, Peter Young, Bridget Graffy, Jonathan Sheridan, Rebecca Watt, Ian Baines, Paul Stones, Catherine Preston, Jennifer Higgins, Steven Gamble, Carrol Knapp, Peter Trials Study Protocol BACKGROUND: Randomised 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. METHODS: The 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. DISCUSSION: This 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 REGISTRATION: ISRCTN registry: ISRCTN73136092 (doi:10.1186/ISRCTN73136092). Registered on 24 August 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1962-z) contains supplementary material, which is available to authorized users. BioMed Central 2017-06-08 /pmc/articles/PMC5465557/ /pubmed/28595613 http://dx.doi.org/10.1186/s13063-017-1962-z Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Martin-Kerry, Jacqueline
Bower, Peter
Young, Bridget
Graffy, Jonathan
Sheridan, Rebecca
Watt, Ian
Baines, Paul
Stones, Catherine
Preston, Jennifer
Higgins, Steven
Gamble, Carrol
Knapp, Peter
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5465557/
https://www.ncbi.nlm.nih.gov/pubmed/28595613
http://dx.doi.org/10.1186/s13063-017-1962-z
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