Parent Participation and Physician-Parent Communication During Informed Consent in Child Leukemia

OBJECTIVE: In this study we evaluated the effectiveness of a physician-directed intervention at enhancing positive physician behaviors and communication strategies during informed consent conferences (ICCs) for pediatric acute leukemia clinical trials. PATIENTS AND METHODS: Physicians at 2 large pediatric hospitals were recruited to participate in a physician-directed intervention (PDI), which included 1 full-day seminar and successive half-day booster sessions. ICCs were then observed, audiotaped, coded, and analyzed to evaluate the effectiveness of the intervention. Data also were collected at 2 control sites. Between 2003 and 2007, 59 ICCs were observed and analyzed. RESULTS: Significant group differences were found in physician rapport-building behaviors. Physicians in the PDI + booster session group engaged in greater rapport-building than did physicians in the PDI group who did not attend booster sessions and physicians in the control group. No group differences were detected for physician partnership-building. In addition, parents in the PDI + booster session group engaged in more general communication and study-related communication, and mothers in the PDI groups asked significantly more questions per minute than did mothers in the control group. CONCLUSIONS: These results provide support for the effectiveness of the PDI at enhancing positive physician behaviors. Booster-session attendance is a critical component of physician-directed interventions to improve parental participation and physician-parent communication during ICCs. Pediatrics 2011;128:e1544-e1551