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 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...
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BioMed Central
2017-06-01
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1962-z |
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doaj-art-5427643e183549eb8bed2802dc0fffbb2018-08-20T14:34:30ZengBioMed CentralTrials1745-62152017-06-0118111210.1186/s13063-017-1962-zDeveloping 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 trialsJacqueline Martin-Kerry0Peter Bower1Bridget Young2Jonathan Graffy3Rebecca Sheridan4Ian Watt5Paul Baines6Catherine Stones7Jennifer Preston8Steven Higgins9Carrol Gamble10Peter Knapp11Department of Health Sciences, University of YorkMRC North West Hub for Trials Methodology Research, NIHR School for Primary Care Research, University of ManchesterMRC North West Hub for Trials Methodology Research, Department of Psychological Sciences, Institute of Psychology, Health and Society, University of LiverpoolDepartment of Public Health and Primary Care, University of Cambridge, Institute of Public HealthDepartment of Health Sciences, University of YorkDepartment of Health Sciences and the Hull York Medical School, University of YorkPaediatric Intensive Care Unit, Alder Hey HospitalSchool of Design, Clothworkers’ Central, University of LeedsNIHR Alder Hey Clinical Research Facility, University of Liverpool, Institute in the Park, Alder Hey Children’s NHS Foundation TrustSchool of Education, University of DurhamInstitute of Translational Medicine, University of LiverpoolDepartment of Health Sciences and the Hull York Medical School, University of YorkAbstract 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.http://link.springer.com/article/10.1186/s13063-017-1962-zMultimediaInterventionTrial participationChildAdolescentInformation |
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English |
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Article |
| author |
Jacqueline Martin-Kerry Peter Bower Bridget Young Jonathan Graffy Rebecca Sheridan Ian Watt Paul Baines Catherine Stones Jennifer Preston Steven Higgins Carrol Gamble Peter Knapp |
| spellingShingle |
Jacqueline Martin-Kerry Peter Bower Bridget Young Jonathan Graffy Rebecca Sheridan Ian Watt Paul Baines Catherine Stones Jennifer Preston Steven Higgins Carrol Gamble Peter Knapp 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 Trials Multimedia Intervention Trial participation Child Adolescent Information |
| author_facet |
Jacqueline Martin-Kerry Peter Bower Bridget Young Jonathan Graffy Rebecca Sheridan Ian Watt Paul Baines Catherine Stones Jennifer Preston Steven Higgins Carrol Gamble Peter Knapp |
| author_sort |
Jacqueline Martin-Kerry |
| 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_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_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_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 |
| publisher |
BioMed Central |
| series |
Trials |
| issn |
1745-6215 |
| publishDate |
2017-06-01 |
| description |
Abstract 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. |
| topic |
Multimedia Intervention Trial participation Child Adolescent Information |
| url |
http://link.springer.com/article/10.1186/s13063-017-1962-z |
| _version_ |
1612688874504454144 |