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Improving Informed Consent Process for Trauma Patients in the Emergency Department

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.
ClinicalTrials.gov Identifier: NCT01338480
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Trauma Surgery Other: video

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Informed Consent Process for Trauma Patients in the Emergency Department
Actual Study Start Date : November 9, 2009
Primary Completion Date : October 22, 2014
Study Completion Date : October 22, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: video
Participants in the intervention group watched an educational video illustrating informed consent information
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.
No Intervention: control
Participants in the control group read an informed consent document.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338480


Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Yen-Ko Lin, M.D. Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information

Responsible Party: Yen-Ko Lin, Attending Physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01338480     History of Changes
Other Study ID Numbers: KMUH-IRB-980361
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital:
trauma
surgery
informed consent

Additional relevant MeSH terms:
Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes