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ISRCTN
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ISRCTN20081026
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DOI
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10.1186/ISRCTN20081026
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised controlled trial to assess the impact of audiotaped consultations on the quality of informed consent in cardiac surgery
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Scientific title
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Acronym
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N/A
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Serial number at source
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Version 2, 24/05/2004
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Study hypothesis
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Audiotaping outpatient consultations could improve informed consent in cardiac surgery
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Lay summary
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Ethics approval
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This trial was approved by the Institutional Ethics Committee of Glasgow Royal Infirmary in November 2004
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Coronary artery disease
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Participants - inclusion criteria
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1. Both males and females, no age limits
2. Patients undergoing first time coronary artery bypass graft (CABG) surgery with a single consultant surgeon
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Participants - exclusion criteria
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1. Patients undergoing CABG + valve surgery
2. Patients undergoing redo (second or third time) CABG
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Anticipated start date
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10/02/2005
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Anticipated end date
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15/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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84
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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.
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Sources of funding
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Glasgow Royal Infirmary, Department of Cardiothoracic Surgery (UK)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20404290
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Contact name
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Mr
Andrew
Murday
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Address
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West of Scotland Heart and Lung Centre
Beardmore Street
Clydebank
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City/town
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Glasgow
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Zip/Postcode
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G81 4HX
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Country
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United Kingdom
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Tel
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+44 (0)141 951 5017
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Fax
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+44 (0)141 951 5859
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Email
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andrew.murday@gjnh.scot.nhs.uk
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Sponsor
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Glasgow Royal Infirmary (UK)
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Address
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Department of Cardiothoracic Surgery
Alexandra Parade
Glasgow
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City/town
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Scotland
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Zip/Postcode
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G31 2ER
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Country
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United Kingdom
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Tel
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+44 (0)141 951 5017
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Fax
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+44 (0)141 951 5859
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Email
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mishrapk_25@yahoo.com
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Date applied
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12/07/2008
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Last edited
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21/04/2010
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Date ISRCTN assigned
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16/07/2008
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