A physician-directed intervention: teaching and measuring better informed consent.

Area of Science:

• Pediatric Oncology
• Clinical Research Communication
• Medical Education

Background:

• Effective communication is crucial in pediatric oncology clinical trials.
• Informed consent conferences (ICC) for childhood leukemia trials require clear physician-parent dialogue.
• Traditional training methods may not adequately prepare physicians for complex ICCs.

Purpose of the Study:

• To enhance physician communication with parents during childhood leukemia clinical trial informed consent conferences (ICC).
• To evaluate a physician-directed intervention (PDI) emphasizing a sequenced approach to ICCs.
• To improve parental understanding of diagnosis, prognosis, and treatment options before trial offers.

Main Methods:

• Physicians and fellows received training through Informed Consent Seminars and booster sessions.
• A multisite study observed and audiotaped real-life ICCs, followed by parent interviews.
• Trained physician performance was compared to untrained controls using coded data from 2003-2007.

Main Results:

• Trained physicians more consistently followed the sequenced approach compared to controls.
• Physicians in the PDI group elicited parental questions and clarified understanding more frequently.
• Parental comprehension was assessed through post-conference interviews.

Conclusions:

• Academic physicians require specific training for effective ICCs in clinical research.
• The "see one, do one, teach one" model is insufficient for modern informed consent processes.
• Enhanced communication strategies are vital for ethical and effective clinical trial participation.