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

Abstract

Objective: To evaluate the effect of audiotaping outpatient consultations on informed consent for cardiac surgery.

Design: Randomized controlled trial.

Setting: Tertiary health care center in Scotland.

Participants: Eighty-four patients who had first-time coronary artery surgery conducted by 1 surgeon from February 10, 2005, through March 15, 2006, whose consultations before surgery were audiotaped.

Intervention: Randomization to 3 trial arms. The control group (n = 29) received no tape. The generic group (n = 25) received a tape about coronary artery surgery, which we scripted to include information covering the domains described by the General Medical Council. The consultation group (n = 30) received a tape of their consultation interview. On admission to the hospital, patients were interviewed with the Knowledge Questionnaire, the Multidimensional Health Locus of Control, and the Hospital Anxiety and Depression Scale.

Main outcome measures: The effect of audiotaping in improving the informed consent process for cardiac surgery.

Results: The mean knowledge score of patients in the consultation group was much higher than that of the control individuals (P < .001). Patients in the consultation group reported a significantly greater sense of control with regard to their own health (P < .001) and being less anxious and depressed overall.

Conclusion: Providing an audiotaped recording of the consultation before cardiac surgery appears to improve patients' knowledge and perceptions of control of their health status and to reduce anxiety and depression.

Trial registration: isrctn.org Identifier: ISRCTN20081026.