Multicenter social media community consultation for an exception from informed consent trial of the XStat device (PhoXStat trial)

Abstract

Introduction: Community consultation (CC) is a key step for exception from informed consent research. Using social media to conduct CC is becoming more widely accepted but has largely been conducted by single sites. We describe our experience of a social media-based CC for a multicenter clinical trial, coordinated by the lead clinical site.

Methods: Multicenter CC was administered by the lead site and conducted in preparation for a three-site prehospital randomized clinical trial. We used Facebook and Instagram advertisements targeted to the population of interest. When "clicked," the advertisements directed individuals to study-specific websites, providing additional information and the opportunity to opt out. The lead institution and one other hospital relied on a single website, whereas the third center set up their own website. Site views were evaluated using Google analytics.

Results: The CC took 8 weeks to complete for each site. The advertisements were displayed 9.8 million times, reaching 332,081 individuals, of whom 1,576 viewed one of the study-specific websites. There were no requests to opt out. The total cost was $3,000. The costs per person reached were $1.88, $2.00, and $1.85 for each of the three sites. A number of site-specific issues (multiple languages, hosting of study-specific websites) were easily resolved.

Conclusion: This study suggests that it is possible for one institution to conduct multiple, simultaneous, social media-based CC campaigns, on behalf of participating trial sites. Our results suggest that this social media CC model reaches many more potential subjects and is economical and more efficient than traditional methods.

Level of evidence: Epidemiological, level IV.

Trial registration: ClinicalTrials.gov NCT04663087.