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A randomised controlled trial to assess the impact of audiotaped consultations on the quality of informed consent in cardiac surgery
ISRCTN ISRCTN20081026
DOI 10.1186/ISRCTN20081026
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial to assess the impact of audiotaped consultations on the quality of informed consent in cardiac surgery
Scientific title
Acronym N/A
Serial number at source Version 2, 24/05/2004
Study hypothesis Audiotaping outpatient consultations could improve informed consent in cardiac surgery
Lay summary
Ethics approval This trial was approved by the Institutional Ethics Committee of Glasgow Royal Infirmary in November 2004
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Coronary artery disease
Participants - 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
Participants - exclusion criteria 1. Patients undergoing CABG + valve surgery
2. Patients undergoing redo (second or third time) CABG
Anticipated start date 10/02/2005
Anticipated end date 15/03/2006
Status of trial Completed
Patient information material
Target number of participants 84
Interventions 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.
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
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.
Sources of funding Glasgow Royal Infirmary, Department of Cardiothoracic Surgery (UK)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20404290
Contact name Mr  Andrew  Murday
  Address West of Scotland Heart and Lung Centre
Beardmore Street
Clydebank
  City/town Glasgow
  Zip/Postcode G81 4HX
  Country United Kingdom
  Tel +44 (0)141 951 5017
  Fax +44 (0)141 951 5859
  Email andrew.murday@gjnh.scot.nhs.uk
Sponsor Glasgow Royal Infirmary (UK)
  Address Department of Cardiothoracic Surgery
Alexandra Parade
Glasgow
  City/town Scotland
  Zip/Postcode G31 2ER
  Country United Kingdom
  Tel +44 (0)141 951 5017
  Fax +44 (0)141 951 5859
  Email mishrapk_25@yahoo.com
Date applied 12/07/2008
Last edited 21/04/2010
Date ISRCTN assigned 16/07/2008
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