Clinical trial NCT01955070: Use of a Multimedia Presentation for Informed Consent
Official title: Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improving Informed Consent Process
Keywords: Informed consent
Ethics
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 184
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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:
measure: Parents' satisfaction with the informed consent process
timeFrame: Within 1 hour of consent
measure: The parent's knowledge of ketamine sedation.
timeFrame: Within one hour of consent
Secondary outcomes:
measure: Satisfaction within each domain
timeFrame: Within one hour of consent
measure: Comparison of satisfaction and knowledge with demographics
timeFrame: Within one hour of consent
measure: Provider Satisfaction
timeFrame: Time 0 and 6 months later
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Childrens
state: Ohio
Study officials:
affiliation: Nationwide Childrens, Department of Emergency Medicine
name: Sandra P Spencer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Informed consent for elective and emergency surgery: questionnaire study. BJOG. 2004 Oct;111(10):1133-8. doi: 10.1111/j.1471-0528.2004.00240.x.
citation: Baren J, Campbell CF, Schears RM, Shofer FS, Datner EM, Hollander JE. Observed behaviors of subjects during informed consent for an emergency department study. Ann Emerg Med. 2010 Jan;55(1):9-14. doi: 10.1016/j.annemergmed.2009.09.023. Epub 2009 Nov 22.
citation: Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003 Nov-Dec;25(6):1-7. No abstract available.
citation: Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-601. doi: 10.1001/jama.292.13.1593.
citation: Nwomeh BC, Hayes J, Caniano DA, Upperman JS, Kelleher KJ. A parental educational intervention to facilitate informed consent for emergency operations in children. J Surg Res. 2009 Apr;152(2):258-63. doi: 10.1016/j.jss.2008.01.008. Epub 2008 Feb 4.
citation: Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department. Pediatr Emerg Care. 2015 Aug;31(8):572-6. doi: 10.1097/PEC.0000000000000513.