This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. The goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process.
BACKGROUND: Informed consent (IC) is an ethical process for ensuring patient autonomy. Multimedia presentations (MMP) often aid the IC process for research studies. Thus, it follows that MMP would improve IC in clinical settings. OBJECTIVE: To determine if MMP for the IC process for ketamine sedation improves parental satisfaction and comprehension as compared to standard practice. DESIGN/METHODS: This two phase study compared two methods of IC for ketamine sedation of pediatric patients. Phase one was a randomized, prospective study that compared the standard verbal consent to a MMP. Phase two implemented the MMP into daily work flow. Parents completed a survey evaluating their satisfaction of the IC process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the IC process and knowledge of ketamine sedation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
184
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Nationwide Childrens
Columbus, Ohio, United States
Parents' satisfaction with the informed consent process
Parents are given a survey with a 5-point Likert scale to evaluated their satisfaction with the informed consent process
Time frame: Within 1 hour of consent
The parent's knowledge of ketamine sedation.
The parents are give a multiple choice quiz on the information present on ketamine sedation
Time frame: Within one hour of consent
Satisfaction within each domain
The satisfaction questions on the survey are divided into groups addressing the four key elements of informed consent: beneficence, maleficence, content, and assent.
Time frame: Within one hour of consent
Comparison of satisfaction and knowledge with demographics
The survey and quiz results are compared depending on demographics
Time frame: Within one hour of consent
Provider Satisfaction
Provider satisfaction was collected using a Likert scale at the time the presentation was embedded into the computer order entry system. They were re-surveyed 6 months later to see if there was any change in the satisfaction results
Time frame: Time 0 and 6 months later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.