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Redesign of an informed consent form to increase participation in a school‐based dental program
Author(s) -
Mantilla Rodriguez Andres A.,
Soto Armando,
Martinez Mier E. Angeles
Publication year - 2020
Publication title -
journal of public health dentistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 63
eISSN - 1752-7325
pISSN - 0022-4006
DOI - 10.1111/jphd.12437
Subject(s) - health insurance portability and accountability act , informed consent , medical education , accountability , psychology , medicine , family medicine , health care , political science , alternative medicine , law , pathology
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.