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Improving Informed Consent Process for Trauma Patients in the Emergency Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01338480
First Posted: April 19, 2011
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
April 18, 2011
April 19, 2011
April 7, 2017
November 9, 2009
October 22, 2014   (Final data collection date for primary outcome measure)
knowledge score [ Time Frame: immediately after the intervention ]
The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination
knowledge score [ Time Frame: immediately and 3 months after the intervention ]
The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination
Complete list of historical versions of study NCT01338480 on ClinicalTrials.gov Archive Site
satisfaction [ Time Frame: immediately after the intervention ]
Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.
satisfaction and completion time [ Time Frame: immediately after the intervention ]
Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale, and the time to complete the consent process for the surgery.
Not Provided
Not Provided
 
Improving Informed Consent Process for Trauma Patients in the Emergency Department
Improving Informed Consent Process for Trauma Patients in the Emergency Department
This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Trauma
  • Surgery
Other: 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.
  • Experimental: video
    Participants in the intervention group watched an educational video illustrating informed consent information
    Intervention: Other: video
  • No Intervention: control
    Participants in the control group read an informed consent document.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
October 22, 2014
October 22, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • scheduled to receive the surgery

Exclusion Criteria:

  • clinically unstable
  • refuse to participate
  • unable to understand the consent process for this study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01338480
KMUH-IRB-980361
No
Not Provided
Not Provided
Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: Yen-Ko Lin, M.D. Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP