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Use of a Multimedia Presentation for Informed Consent

Nationwide Children's Hospital logo

Nationwide Children's Hospital

Status

Completed

Conditions

Improving Informed Consent Process

Treatments

Other: Multimedia Presentation for Ketamine sedation

Study type

Interventional

Funder types

Other

Identifiers

NCT01955070
MMP for Informed Consent

Details and patient eligibility

About

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.

Full 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.

Enrollment

184 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

184 participants in 3 patient groups

Implementation
Experimental group
Description:
Multimedia Presentation for Ketamine sedation
Treatment:
Other: Multimedia Presentation for Ketamine sedation
Intervention
Experimental group
Description:
Multimedia Presentation for Ketamine sedation
Treatment:
Other: Multimedia Presentation for Ketamine sedation
Control
No Intervention group
Description:
Patients that received the standard consent with signed consent form

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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