A randomised controlled trial to assess the impact of audiotaped consultations on the quality of informed consent in cardiac surgery

Completed

• Conditions: Coronary artery disease; Circulatory System; Chronic ischaemic heart disease

• Registration Number: ISRCTN20081026
• Lead Sponsor: Glasgow Royal Infirmary (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Both males and females, no age limits
2. Patients undergoing first time coronary artery bypass graft (CABG) surgery with a single consultant surgeon

Exclusion Criteria

1. Patients undergoing CABG + valve surgery
2. Patients undergoing redo (second or third time) CABG

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of audiotape in improving the informed consent process, as measured by a knowledge questionnaire, in cardiac surgery. The assessment was carried out a day before surgery within 2 hours of signing the consent form.<br><br>Publication of the result of a pilot study to design and validate the knowledge questionnaire can be found at http://www.ncbi.nlm.nih.gov/pubmed/16932081

Secondary Outcome Measures

Name	Time	Method
Impact of audiotapes on the Health Locus of Control Scale and the Health Anxiety and Depression Scale. The assessment was carried out a day before surgery within 2 hours of signing the consent form.