Abstract
BACKGROUND: Research on parental understanding of informed consent for pediatric randomized clinical trials (RCTs) has highlighted weaknesses in understanding of key aspects of informed consent. The goals of the current study were to assess the feasibility of and parental satisfaction with a video intervention to improve informed consent for pediatric leukemia RCTs and to compare parental question asking during informed consent conferences (ICCs) for parents in the current study with historical control data. PROCEDURE: A 20-min video was produced. Utilizing the principles of anticipatory guidance, it included information delivered by nurses and physicians about leukemia and key aspects of informed consent. Parents were encouraged to be active participants in ICCs. Participants included 12 parents of children newly diagnosed with pediatric leukemia. The video was viewed by local pediatric oncologists prior to utilization with families. RESULTS: Ninety-two percent of parents reported that the video made it easier to understand information that their child's physician later provided; 83% of parents reported that it helped them to think of questions to ask the physician; and 67% of parents indicated that the video made them feel more comfortable with asking questions of the physician. Results of a t-test comparing question asking during ICCs revealed that parents who participated in the intervention asked a higher rate of questions than parents from a historical control sample (t = 1.95, P = 0.05). DISCUSSION: Our study supports the feasibility and potential efficacy of a brief video intervention employing anticipatory guidance to prepare parents for future discussions about RCTs.