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Completed

NCT Number: NCT01955070

Use of a Multimedia Presentation for Informed Consent

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.

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Key information

Conditions

Improving Informed Consent Process

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Childrens

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimedia Presentation for Ketamine sedation

Other

PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation

Primary outcomes

  1. 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

  2. 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

  1. Satisfaction within each domain

    Time frame: 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.

  2. Comparison of satisfaction and knowledge with demographics

    Time frame: Within one hour of consent

    The survey and quiz results are compared depending on demographics

  3. Provider Satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2013
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.