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A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for
Denise LaMarra1, Jaclyn French2, Christine Bailey3
1Standardized Patient Program, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
Insights
Telesimulation with standardized parents is a feasible and cost-effective method to train research staff in obtaining informed consent for pediatric clinical trials. However, this training did not significantly improve study consent rates.
Area of Science:
- Pediatric critical care research
- Clinical trial recruitment strategies
- Medical simulation in education
Background:
- Low informed consent rates hinder enrollment in the Heart and Lung Failure-Pediatric INsulin Titration study.
- Traditional training methods for research staff may not adequately prepare them for sensitive consent discussions with parents of critically ill children.
Purpose of the Study:
- To evaluate the feasibility, learner acceptance, and cost-effectiveness of telesimulation using standardized parents for training research staff.
- To determine if this telesimulation intervention improves informed consent rates in a pediatric clinical trial.
Main Methods:
- An observational, comparative effectiveness study involving 79 research staff across 24 sites.
- Individual 90-minute Skype telesimulation sessions with standardized parents and facilitators were conducted.
- A post hoc analysis compared consent rates before and after the intervention.
Main Results:
- All 40 scheduled telesimulation sessions were completed, with 100% of participants finding the training effective and applicable.
- Telesimulation demonstrated lower financial costs ($85/session) compared to traditional in-person training.
- No significant improvement in study consent rates was observed (pre: 46% vs. post: 48%, p=0.78).
Conclusions:
- Remote telesimulation with standardized parents is a feasible, acceptable, and cost-effective method for training research staff on obtaining informed consent.
- The intervention did not improve consent rates, indicating that other factors influence parental decision-making in complex pediatric clinical trials.
Objectives:
The Heart And Lung Failure-Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure-Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates.
Design:
Observational, comparative effectiveness study.
Setting:
Heart And Lung Failure-Pediatric INsulin Titration study enrolling sites.
Subjects:
Research staff (at the remote site).
Interventions:
Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site).
Measurements And Main Results:
Forty telesimulation sessions with 79 Heart And Lung Failure-Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents 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 respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with 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 standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure-Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.
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