Patient-physician communication: informed consent for imaging-guided spinal injections.

PURPOSE: Historically, informed-consent forms have been developed for the purpose of educating patients. However, informed-consent forms can be very difficult to understand. The hypothesis of this study was that a method using diagrams would improve patient-physician communication without increasing the time required to obtain informed consent over the teach-the-teacher method, as well as over current standard informed-consent protocol.
METHODS: Ninety-nine of 109 patients undergoing spinal injections agreed to participate and completed this prospective, randomized, controlled study. The patients were randomly assigned to the control group (informed consent obtained in the customary manner at the investigators' institution, with 12 key points of consent and home care discussed conversationally), the teach-the-teacher group (patients had to repeat the 12 key points to the physicians before informed consent was complete), and the diagram group (patients viewed a set of diagrams illustrating the 12 key points before signing the informed-consent form). After the procedure, the patients completed a survey to test knowledge recall, anxiety, and pain during the procedure.
RESULTS: Statistically significant results included a lower survey score for the control group, longer time required for the teach-the-teacher group than the control group, and a negative correlation between age and survey score in the teach-the-teacher group.
CONCLUSIONS: The diagram method required less time than the teach-the-teacher method, had no negative correlation in survey score results with age, and had improved patient-physician communication over the control group.

RCT Entities:   Population Interventions Outcomes