Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Improving Informed Consent Process
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Parents' satisfaction with the informed consent process
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Sandra Spencer
Assistant Professor of Clinical Pediatrics
Nationwide Children's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Parents' satisfaction with the informed consent process
Time Frame: 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.
Time Frame: Within one hour of consent
The parents are give a multiple choice quiz on the information present on ketamine sedation
Secondary Outcomes
- Satisfaction within each domain(Within one hour of consent)
- Comparison of satisfaction and knowledge with demographics(Within one hour of consent)
- Provider Satisfaction(Time 0 and 6 months later)