Use of a Multimedia Presentation for Informed Consent

September 27, 2013 updated by: Sandra Spencer, Nationwide Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Childrens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Implementation
Multimedia Presentation for Ketamine sedation
Other: Multimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
EXPERIMENTAL: Intervention
Multimedia Presentation for Ketamine sedation
Other: Multimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
NO_INTERVENTION: Control
Patients that received the standard consent with signed consent form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 1 hour of consent
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
Within one hour of consent

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Sandra P Spencer, MD, Nationwide Childrens, Department of Emergency Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (ESTIMATE)

October 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMP for Informed Consent

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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