Abstract 135: Integration of Social Media With Targeted Emails and interviews for Exception From Informed Consent Community Consultation

Abstract

Introduction: Exception from informed consent (EFIC) enables the enrollment of subjects with emergent conditions for clinical trials without prior consent. All EFIC studies are required to include community consultation (CC). However, CC implementation is often challenged by significant cost and scarce community engagement. Hypothesis: We hypothesize that the utilization of social media, targeted emails, and interviews of at-risk individuals and their caretakers can lead to more effective EFIC CC. Methods: We utilized social media and targeted emails/interviews for the EFIC CC of the ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-Segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest Trial. We disseminated study advertisements with survey links and opt-out option using Facebook/Instagram to our communities and targeted emails to prehospital and cardiology providers. We also interviewed at-risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Between-group comparisons of proportions were tested using modified chi-squared tests for small sample size. Results: We collected 559 fully or partially completed surveys over an eight-week period. The majority of the surveys (70.5%) were obtained using social media. The mean age was 45 years; 90% were white and 61% were female. Overall, 91.3% believed ACCESS is an important study. The interview group had significantly more loved ones with cardiac arrest than the social media (50% vs 36.7%, p < 0.05) or targeted email (50% vs 23.6%, p < 0.005) group. Compared to the interview group, more from social media (81.8% vs 63.3%, p < 0.05) and targeted email (77.4% vs 63.3, p < 0.05) groups said they would include their loved ones in the study. More from the interview group believed that their opinion would be considered seriously compared to the social media (75.9% vs 62.6%, p < 0.05) and targeted email (75.9% vs 54.5%, p < 0.05) groups. No one opted out from the study. Conclusions: The integration of social media with targeted emails and interviews is an effective approach for EFIC CC. Future work is necessary to determine the perception and best utilization of these strategies for EFIC studies.