Improving Informed Consent Process for Trauma Patients in the Emergency Department

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01338480

Enrollment

172

Registered

2011-04-19

Start date

2009-11-09

Completion date

2014-10-22

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Trauma

Keywords

trauma, surgery, informed consent

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.

Interventions

OTHERvideo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
knowledge score	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

Measure	Time frame	Description
satisfaction	immediately after the intervention	Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026