Does digital, multimedia information increase recruitment and retention in a children’s wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)
Abstract:ObjectivesTo evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.DesignStudy Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.SettingEmergency departments in 23 UK hospitals.Participants1409 children aged 4–16 years attending with a torus (buckle) fracture, and their parents/guardian. Children’s mean ag… Show more
“…3 and the results of the six individual SWATs are reported in Tables 4 , 5 , and 6 . The results of the FORCE and Thermic-3 SWATs have already been reported individually [ 55 , 56 ], and the results of the CHAMP-UK SWAT are reported in Supplementary Material 3 . Fig.…”
Background
Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making.
Methods
We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis.
Results
Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). 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 MMI-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.
“…3 and the results of the six individual SWATs are reported in Tables 4 , 5 , and 6 . The results of the FORCE and Thermic-3 SWATs have already been reported individually [ 55 , 56 ], and the results of the CHAMP-UK SWAT are reported in Supplementary Material 3 . Fig.…”
Background
Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making.
Methods
We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis.
Results
Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). 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 MMI-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.
“…That study showed that EAs improved participants’ knowledge about and attitudes toward clinical trials and were more effective than any of the brochures, especially for those individuals with low motivation and low literacy to comprehend health-related information. Small standalone and embedded trials and a meta-analysis have also shown that the use of multimedia information can make information about trials easier to understand and may increase trial recruitment rates [ 12 – 15 ]. However, a recent meta-analysis of 5 studies within a trial (SWATs) showed that multimedia alongside written information did not improve trial recruitment rates [ 16 ].…”
Background
Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology used to deliver this material is expanding rapidly but is highly fragmented. Usage of explainer animations across the UK is unknown, the aim of this research was to determine current usage across the 52 registered UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) to understand the current landscape and any barriers that could be preventing wider uptake of this functionality.
Methods
A survey link was emailed to all UKCRC CTU Directors and Trial Management Leads to ascertain current usage of explainer animations within their CTU. The survey ran between 01 February 2023 and 07 March 2023.
Results
Responses were received from 35 CTUs—representing a response rate of 67%. 24 CTUs (69%) reported that they had created/used at least one explainer animation within their unit, although the usage, cost, length and production activities varied among the units.
Conclusions
The survey showed that a high proportion of the UKCRC CTUs have used explainer animations to provide information to participants about clinical studies. For those not using the technology yet, the most common reasons cited were a lack of expertise, lack of resources and costs to produce them. One of the desired outcomes of this project is the creation of a free-to-use library of animations to encourage wider uptake and avoid duplication.
“…FIGURE 8Forest plot of the modified ITT trial recruitment analysis for MMI-only compared with PIS-only. (The figure includes data from two published studies 154,155 ). …”
mentioning
confidence: 99%
“…Forest plot of the trial retention analysis for MMI-only compared with PIS-only. (The figure includes data from two published studies 154,155. ) -Making Questionnaire mean and standard deviation for each trial, by TRECA allocation, and version of the DMQ, and results of the comparisons…”
mentioning
confidence: 99%
“…-Making Questionnaire results by arm, including only participants who fully completed the measure Forest plot of the DMQ results comparing MMI-only with PIS-only for the parent/family version. (The figure includes data from two published studies 154,155 ). …”
Background
The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people.
Objectives
The study objectives were as follows:
to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials
to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets.
Design
Two-phase study:
multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement
multimedia information resources’ evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people.
Setting
United Kingdom trials involving patients aged under 18.
Participants
Development phase: n = 120 (children and young people, parents, clinicians, trial personnel).
Evaluation phase: n = 1906 (children and young people being asked to take part in trials).
Interventions
Multimedia information resources (comprising text, audio, ‘talking heads’ video, trial-specific and trial-generic animations). Printed participant information sheets.
Main outcome measures
Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision.
Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making.
Results for each trial were calculated and combined in a two-stage random-effects meta-analysis.
Results
Phase 1 generated two multimedia information resource templates: (1) for children aged 6–11 years; (2) for children aged 12–18 years and parents.
In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality.
In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of ‘information was easy to understand’ (Z = 3.03; p = 0.003) and ‘I had confidence in decision-making’ (Z = 2.00; p = 0.044) than printed participant information sheet-only provision.
Limitations
It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings.
Conclusions
Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets.
Future work
There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents.
Study registration
This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97).
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.
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