Use of a Multimedia Presentation for Informed Consent

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department

Conditions
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Improving Informed Consent Process

Intervention / Treatment
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* Other: Multimedia Presentation for Ketamine sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation<br>Multimedia Presentation for Ketamine sedation | Other: Multimedia Presentation for Ketamine sedation<br>* PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation<br>|
| Experimental: Intervention<br>Multimedia Presentation for Ketamine sedation | Other: Multimedia Presentation for Ketamine sedation<br>* PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation<br>|
| No Intervention: Control<br>Patients that received the standard consent with signed consent form | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Within one hour of consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within one hour of consent | 
| Comparison of satisfaction and knowledge with demographics | The survey and quiz results are compared depending on demographics | 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 0 and 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informed consent, Ethics