Redesign of an informed consent form to increase participation in a school-based dental program.

ABSTRACT

OBJECTIVES: The study aimed to determine if modifications to the design of a consent form and consenting process increased participation rates in the Indiana University School of Dentistry's Mobile School-Based Dental Program (Seal Indiana). METHODS: Kaizen methodology was followed to identify problem areas in the consenting process. Additionally, stakeholders were invited to participate in focus groups and fill out surveys to identify issues preventing participation in the Seal Indiana program (N = 48) and later to evaluate the changes made (N = 48). The redesigned form and process were then used in a pilot study at 14 sites to determine the impact that changes had on levels of participation as measured by the number of consent forms completed and returned. RESULTS: There was a statistically significant increase in the number of consent forms returned. The measured change represented a 32 percent increase in program participation (P value = 0.035). A statistically significant increase was observed in how participants viewed the attractiveness of the form and how easy it was to read and comprehend. CONCLUSIONS: In order to increase consenting rates, our results indicate modifications to the consent form should be focused on the following characteristics esthetics, ease of reading and comprehending information, and making the Health Insurance Portability and Accountability Act of 1996 (HIPPA) privacy regulations easier to read and comprehend.