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Completed

NCT Number: NCT01338480

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.

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Key information

Conditions

Trauma Surgery Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2011
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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