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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation | Experimental | Multimedia Presentation for Ketamine sedation |
|
| Intervention | Experimental | Multimedia Presentation for Ketamine sedation |
|
| Control | No Intervention | Patients that received the standard consent with signed consent form |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimedia Presentation for Ketamine sedation | Other | PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parents' satisfaction with the informed consent process | 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. | The parents are give a multiple choice quiz on the information present on ketamine sedation | Within one hour of consent |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction within each domain | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra P Spencer, MD | Nationwide Childrens, Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Childrens | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15383117 | Background | 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. | |
| 19931940 | Background | 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. |
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The survey and quiz results are compared depending on demographics |
| Within one hour of consent |
| Provider Satisfaction | 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 |
| 15035248 | Background | Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003 Nov-Dec;25(6):1-7. No abstract available. |
| 15467062 | Background | 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. |
| 18374948 | Background | 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. |
| 26221786 | Derived | 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. |