Condition category
Circulatory System
Date applied
12/07/2008
Date assigned
16/07/2008
Last edited
21/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Murday

ORCID ID

Contact details

West of Scotland Heart and Lung Centre
Beardmore Street
Clydebank
Glasgow
G81 4HX
United Kingdom
+44 (0)141 951 5017
andrew.murday@gjnh.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2, 24/05/2004

Study information

Scientific title

Acronym

Study hypothesis

Audiotaping outpatient consultations could improve informed consent in cardiac surgery

Ethics approval

This trial was approved by the Institutional Ethics Committee of Glasgow Royal Infirmary in November 2004

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

10/02/2005

Overall trial end date

15/03/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

84

Participant exclusion criteria

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

Recruitment start date

10/02/2005

Recruitment end date

15/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Glasgow Royal Infirmary (UK)

Sponsor details

Department of Cardiothoracic Surgery
Alexandra Parade
Glasgow
Scotland
G31 2ER
United Kingdom
+44 (0)141 951 5017
mishrapk_25@yahoo.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Glasgow Royal Infirmary, Department of Cardiothoracic Surgery (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20404290

Publication citations

  1. Results

    Mishra PK, Mathias H, Millar K, Nagrajan K, Murday A, A randomized controlled trial to assess the effect of audiotaped consultations on the quality of informed consent in cardiac surgery., Arch Surg, 2010, 145, 4, 383-388, doi: 10.1001/archsurg.2010.45.

Additional files

Editorial Notes