Improving Informed Consent Process for Trauma Patients in the Emergency Department

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01338480

First received: April 18, 2011

Last updated: April 5, 2017

Last verified: April 2017

History of Changes

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: Outcomes Assessor Primary Purpose: Health Services Research
Official Title:	Improving Informed Consent Process for Trauma Patients in the Emergency Department

Resource links provided by NLM:

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Further study details as provided by Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:

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:

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.


Enrollment:	172
Actual Study Start Date:	November 9, 2009
Study Completion Date:	October 22, 2014
Primary Completion Date:	October 22, 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

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

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
Study First Received:	April 18, 2011
Last Updated:	April 5, 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

ClinicalTrials.gov processed this record on June 27, 2017

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