Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
184 participants
INTERVENTIONAL
2011-05-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Implementation
Multimedia Presentation for Ketamine sedation
Multimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Intervention
Multimedia Presentation for Ketamine sedation
Multimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Control
Patients that received the standard consent with signed consent form
No interventions assigned to this group
Interventions
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Multimedia Presentation for Ketamine sedation
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Eligibility Criteria
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Inclusion Criteria
* Less than 18 years of age
* English as primary language
Exclusion Criteria
* Families where English was not the primary language
1 Year
18 Years
ALL
No
Sponsors
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Nationwide Children's Hospital
OTHER
Responsible Party
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Sandra Spencer
Assistant Professor of Clinical Pediatrics
Principal Investigators
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Sandra P Spencer, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Childrens, Department of Emergency Medicine
Locations
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Nationwide Childrens
Columbus, Ohio, United States
Countries
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References
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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.
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.
Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003 Nov-Dec;25(6):1-7. No abstract available.
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.
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.
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.
Other Identifiers
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MMP for Informed Consent
Identifier Type: -
Identifier Source: org_study_id