Patients' Comprehension and Internalization of Operative Consent Form

Informed Consent Clinical Trial

Official title:

Informed Pre-operative Consent: Are We There Yet?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627597
• Other study ID #: 2016/2638
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.

Description:

As above and in later sections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Planned for common elective ENT operations

• English-speaking

• Unaccompanied

• Counselled with the use of a structured surgery-specific consent form

Related Conditions & MeSH terms

• Informed Consent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's perceived understanding of information given during pre-operative counselling (nominal score on questionnaire)	The score of how certain patients feel about information given during pre-operative counselling, as indicated on a self-administered questionnaire on the same day after pre-operative counselling	Through study completion, up to 6 months
Primary	Patient's actual understanding of information given during pre-operative counselling (numeric score on questionnaire)	The score of correct answers patients give to factual questions about their surgery, as indicated on a self-administered questionnaire on the same day after pre-operative counselling	Through study completion, up to 6 months
Primary	Patient's satisfaction with pre-operative counselling (nominal score on questionnaire)	The score of how satisfied patients are with pre-operative counselling, as indicated on a self-administered questionnaire on the same day after pre-operative counselling	Through study completion, up to 6 months