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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20081026
Enrollment
84
Registered
2008-07-16
Start date
2005-02-10
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease Circulatory System Chronic ischaemic heart disease

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 Medic
n = 30) received a tape of their consultation interview.

Sponsors

Glasgow Royal Infirmary (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026