Improving Informed Consent Process
Conditions
Keywords
Informed consent, Ethics
Brief summary
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.
Detailed description
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.
Interventions
OTHERMultimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Receiving ketamine sedation for fracture reduction * Less than 18 years of age * English as primary language
Exclusion criteria
* patients who received medications in addition to ketamine for sedation * Families where English was not the primary language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parents' satisfaction with the informed consent process | Within 1 hour of consent | Parents are given a survey with a 5-point Likert scale to evaluated their satisfaction with the informed consent process |
| The parent's knowledge of ketamine sedation. | Within one hour of consent | The parents are give a multiple choice quiz on the information present on ketamine sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction within each domain | Within one hour of consent | The satisfaction questions on the survey are divided into groups addressing the four key elements of informed consent: beneficence, maleficence, content, and assent. |
| Comparison of satisfaction and knowledge with demographics | Within one hour of consent | The survey and quiz results are compared depending on demographics |
| Provider Satisfaction | Time 0 and 6 months later | 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 |
Countries
United States
Outcome results
None listed