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Use of a Multimedia Presentation for Informed Consent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01955070
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
Sandra Spencer, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE October 7, 2013
Last Update Posted Date October 7, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
  • 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.
  • Comparison of satisfaction and knowledge with demographics [ Time Frame: Within one hour of consent ]
    The survey and quiz results are compared depending on demographics
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of a Multimedia Presentation for Informed Consent
Official Title  ICMJE Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Improving Informed Consent Process
Intervention  ICMJE Other: Multimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Study Arms  ICMJE
  • Experimental: Implementation
    Multimedia Presentation for Ketamine sedation
    Intervention: Other: Multimedia Presentation for Ketamine sedation
  • Experimental: Intervention
    Multimedia Presentation for Ketamine sedation
    Intervention: Other: Multimedia Presentation for Ketamine sedation
  • No Intervention: Control
    Patients that received the standard consent with signed consent form
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2013)
184
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01955070
Other Study ID Numbers  ICMJE MMP for Informed Consent
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandra Spencer, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandra P Spencer, MD Nationwide Childrens, Department of Emergency Medicine
PRS Account Nationwide Children's Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP