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

ISRCTN	ISRCTN20081026
DOI	https://doi.org/10.1186/ISRCTN20081026
Protocol serial number	Version 2, 24/05/2004
Sponsor	Glasgow Royal Infirmary (UK)
Funder	Glasgow Royal Infirmary, Department of Cardiothoracic Surgery (UK)

Submission date: 12/07/2008
Registration date: 16/07/2008
Last edited: 21/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Andrew Murday
Scientific

West of Scotland Heart and Lung Centre
Beardmore Street
Clydebank
Glasgow
G81 4HX
United Kingdom

Phone	+44 (0)141 951 5017
Email	andrew.murday@gjnh.scot.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Audiotaping outpatient consultations could improve informed consent in cardiac surgery
Ethics approval(s)	This trial was approved by the Institutional Ethics Committee of Glasgow Royal Infirmary in November 2004
Health condition(s) or problem(s) studied	Coronary artery disease
Intervention	The participants were randomly allocated to three trial arms. The control group (Group A; n = 29) received no tape. The 'generic' group (Group B; n = 25) received a copy of a tape which contained general information about coronary artery surgery which we scripted to include information covering each of the domains described by the General Medical Council. The 'consultation' group (Group C; n = 30) received a tape of their consultation interview.
Intervention type	Other
Primary outcome measure(s)	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. 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
Key secondary outcome measure(s)	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.
Completion date	15/03/2006

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	84
Key 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
Key exclusion criteria	1. Patients undergoing CABG + valve surgery 2. Patients undergoing redo (second or third time) CABG
Date of first enrolment	10/02/2005
Date of final enrolment	15/03/2006

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

West of Scotland Heart and Lung Centre

Glasgow
G81 4HX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No