Use of a Multimedia Presentation for Informed Consent

Not Applicable

Completed

• Conditions: Improving Informed Consent Process
• Interventions: Other: Multimedia Presentation for Ketamine sedation

• Registration Number: NCT01955070
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-27
• Last Update Submitted: 2013-09-27
• Study First Posted: 2013-10-07
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implementation	Multimedia Presentation for Ketamine sedation	Multimedia Presentation for Ketamine sedation
Intervention	Multimedia Presentation for Ketamine sedation	Multimedia Presentation for Ketamine sedation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comparison of satisfaction and knowledge with demographics	Within one hour of consent	The survey and quiz results are compared depending on demographics
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.
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

Trial Locations

Locations (1)

Nationwide Childrens; 🇺🇸 Columbus, Ohio, United States