Use of a Multimedia Presentation for Informed Consent

Ketamine

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.

Intervention / Treatment

  • Multimedia Presentation for Ketamine sedation (OTHER)
    PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation

Condition or Disease

  • Improving Informed Consent Process

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 1 Year to 18 Years
    Enrollment: 184 (ACTUAL)
    Funded by: Other
    Allocation: Randomized

    Masking

    Clinical Trial Dates

    Start date: May 01, 2011
    Primary Completion: Aug 01, 2012 ACTUAL
    Completion Date: Dec 01, 2012 ACTUAL
    Study First Posted: Oct 07, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 27, 2013

    Sponsors / Collaborators

    Lead Sponsor: Nationwide Children's Hospital
    Responsible Party: N/A

    Location

    Columbus, Ohio, USA

    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.

    Participant Groups

    • Multimedia Presentation for Ketamine sedation

    • Multimedia Presentation for Ketamine sedation

    • Patients that received the standard consent with signed consent form

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Parents are given a survey with a 5-point Likert scale to evaluated their satisfaction with the informed consent process

    • The parents are give a multiple choice quiz on the information present on ketamine sedation

    Secondary Outcomes

    • The satisfaction questions on the survey are divided into groups addressing the four key elements of informed consent: beneficence, maleficence, content, and assent.

    • The survey and quiz results are compared depending on demographics

    • 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

    More Details

    NCT Number: NCT01955070
    Other IDs: MMP for Informed Consent
    Study URL: https://clinicaltrials.gov/study/NCT01955070
    Last updated: Sep 29, 2023