Improving Informed Consent Process for Trauma Patients in the Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01338480
First received: April 18, 2011
Last updated: August 1, 2011
Last verified: April 2010
  Purpose

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 Intervention
Trauma
Surgery
Other: video

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Informed Consent Process for Trauma Patients in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • knowledge score [ Time Frame: immediately and 3 months after the intervention ] [ Designated as safety issue: No ]
    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:
  • satisfaction and completion time [ Time Frame: immediately after the intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 240
Study Start Date: April 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: video
The intervention group includes patients who obtain information about the surgery from a video will view at their bedside on a laptop.
Other: video
The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338480

Contacts
Contact: Yen-Ko Lin, M.D. +886-7-3121101 ext 7579 yenko@ms16.hinet.net

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Yen-Ko Lin, M.D.    +886-7-3121101 ext 7579    yenko@ms16.hinet.net   
Principal Investigator: Yen-Ko Lin, M.D.         
Sub-Investigator: Chia-Ju Lin, R.N.         
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

No publications provided

Responsible Party: Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01338480     History of Changes
Other Study ID Numbers: KMUH-IRB-980361
Study First Received: April 18, 2011
Last Updated: August 1, 2011
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on August 26, 2014