Improving Informed Consent Process for Trauma Patients in the Emergency Department
NCT ID: NCT01338480
Last Updated: 2017-04-07
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
172 participants
INTERVENTIONAL
2009-11-09
2014-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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video
Participants in the intervention group watched an educational video illustrating informed consent information
video
The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery. The knowledge measure instrument will also be developed.
control
Participants in the control group read an informed consent document.
No interventions assigned to this group
Interventions
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video
The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery. The knowledge measure instrument will also be developed.
Eligibility Criteria
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Inclusion Criteria
* scheduled to receive the surgery
Exclusion Criteria
* refuse to participate
* unable to understand the consent process for this study
18 Years
ALL
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Yen-Ko Lin
Attending Physician
Principal Investigators
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Yen-Ko Lin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University Chung-Ho Memorial Hospital
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
Countries
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References
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Lin YK, Chen CW, Lee WC, Cheng YC, Lin TY, Lin CJ, Shi L, Tien YC, Kuo LC. Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial. BMC Med Ethics. 2018 Mar 9;19(1):23. doi: 10.1186/s12910-018-0264-7.
Lin YK, Chen CW, Lee WC, Lin TY, Kuo LC, Lin CJ, Shi L, Tien YC, Cheng YC. Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique. BMC Med Ethics. 2017 Nov 29;18(1):67. doi: 10.1186/s12910-017-0228-3.
Other Identifiers
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KMUH-IRB-980361
Identifier Type: -
Identifier Source: org_study_id
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