Anesthesia Clinical Trial
Official title:
Audio-recording of Consent for Anaesthesia for Elective Caesarean Section - a Pilot Study
Informed consent should be obtained from patients (with capacity) before treatment -
including anaesthesia - is administered. If the consent process is inadequate, it may lead to
poor decision-making and dissatisfaction, sometimes leading to complaints or legal claims.
Obstetric practice is a high-risk area for medicolegal claims and accurate, reliable
documentation of consent is therefore vital in this group.
The hypothesis is that audio-recording of consent discussions would provide a record of the
discussion for the patient and healthcare staff to refer to later, to assist in understanding
and potentially prevent dissatisfaction, complaints and claims; and may improve the consent
process itself if both parties know that the discussion will be audio-recorded.
This project aims to establish the acceptability and feasibility of audio-recording of
consent for elective caesarean section. The investigators will trial the concept by
establishing audio-recording of consent for anaesthesia for elective caesarean section, and
aim to investigate the views of patients at Chelsea and Westminster Hospital taking part.
The investigators aim to address the following research questions:
- what are the views of patients (and to a lesser extent, doctors) involved in
audio-recording of consent discussions for anaesthesia for elective caesarean section
regarding its acceptability and utility?
- what were the perceived concerns and/or practical obstacles to overcome in the trial of
concept?
This is a pilot study to trial audio-recording of consent and evaluate its potential for use
in day to day clinical care. This study will be a quantitative, observational survey of 20
antenatal maternity patients scheduled for elective caesarean section, who have attended 5-15
days before their planned surgery for anaesthetic consent discussions with audio-recording.
Participants will complete a questionnaire immediately following the recorded discussion and
again within the 48 hours following surgery. The study aims to establish participants' views
on the process of audio-recording of consent and the potential usefulness/acceptability of
the audio-recording.
The antenatal maternity patients will be a random/convenience sample of women booked for
elective caesarean section at Chelsea and Westminster Hospital. These women will be expected
to have a fairly uniform consent discussion with an anaesthetist before their surgery.
Participants will be selected according to the date of the planned caesarean section, their
availability and that of the research team, in turn until 20 women have completed the study
(i.e. have had a recorded discussion, undergone elective caesarean section, and completed the
postnatal questionnaire).
The doctors involved in consent discussions will be a small group of anaesthetists (n = 3) to
maintain consistency; these anaesthetists will also complete questionnaires in order to raise
any themes/issues for further evaluation, whilst accepting that the sample size will be too
small for firm conclusions.
The questionnaires will be completely anonymous and have been designed to minimise bias in
the question wording and structure, with input from patients and staff in the design process.
An anaesthetist will be on hand to facilitate completion of the questionnaires and to assist
with understanding of the questions.
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