Dataset Information

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled 'study within a trial' (SWAT) of a multimedia information resource.

ABSTRACT:

Background

Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates by conducting a pragmatic 'study within a trial' (SWAT) embedding a trial of a multimedia resource within an existing trial.

Methods

The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by patient and public involvement (PPI) contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised.

Results

Nine point six percent of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (odds ratio (OR) = 0.844, 95% confidence interval (CI) 0.58 to 1.22). We also found no effects on the proportion of people responding to the invitation (OR = 1.02, 95% CI 0.79 to 1.33) or retention in the trial at 6 (ORs 0.84, 95% CI 0.57 to 1.22) and 12 months after randomisation (ORs 0.80, 95% CI 0.54 to 1.18), respectively.

Conclusions

The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population.

Trial registration

Current controlled trials ISRCTN 06710391 . Registered on 21 November 2013.

Swat registration

SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START). Registered on 11 January 2012.

SUBMITTER: Jolly K

PROVIDER: S-EPMC6657092 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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 age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language.InterventionsParticipants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728).Outcome measuresPrimary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three 'free text' questions (deriving subjective evaluations) and trial retention.ResultsMMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI -1.23 to 1.32, p=0.94). The MMI group was more likely to report the information 'very easy' to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks' timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).ConclusionsMMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively.Trial registration numberISRCTN73136092 and ISRCTN13955395.

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