823: CAN TELESIMULATION WITH STANDARDIZED PARENTS IMPROVE CRITICAL CARE RESEARCH CONSENT PREPAREDNESS?

Abstract

Learning Objectives: The Heart And Lung Failure–Pediatric INsulin Titration (HALF-PINT) study was experiencing poor subject enrollment due to lower than expected rates of informed consent. HALF-PINT investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with Standardized Parents (SPs) to efficiently and effectively train research staff to approach parents of eligible critically ill children for informed consent. We describe the feasibility, learner acceptance and cost-effectiveness of remote telesimulation with SPs to prepare research staff to obtain informed consent from parents of critically ill children eligible for the HALF-PINT study. We hypothesized that this novel intervention would result in improved study consent rates. Methods: Observational, comparative effectiveness study consisting of individual 90-minute Skype telesimulation sessions with research staff (at the remote site) and SP with simulation facilitator (at the training site). Descriptive analyses were used to summarize data. Results: Forty HALF-PINT research staff at 24 remote sites participated. Despite some technical delays, 40 out of 40 (100%) of simulations were completed. Based on feedback surveys, 100% of consenters agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of consenters agreed (78% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with SPs was cost-effective (approximately $85 per trainee) compared to traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs. post: 48%, p = 0.78). Conclusions: Remote telesimulation with SPs is feasible, acceptable and cost-effective to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, HALF-PINT study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multi-center clinical research trials.