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NCT01476319 Clinical Trial

Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

Cholecystitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01476319
Other study ID # KMUH-IRB-980360
Secondary ID
Status Completed
Phase N/A
First received August 1, 2011
Last updated April 5, 2017
Start date November 9, 2009
Est. completion date September 9, 2014

Study information
Verified date April 2017
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date September 9, 2014
Est. primary completion date September 9, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients 18 years of age or older

- scheduled to receive the percutaneous cholecystostomy

Exclusion Criteria:

- clinically unstable

- refuse to participate

- are unable to understand the study process

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• video
The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.

Locations
Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary knowledge and satisfaction measure One questionnaire will be used as an outcome measure tool. Participants will be asked to complete one questionnaire with knowledge test and satisfaction evaluation with the process of informed consent after the educational sessions. immediately after intervention
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