Audio-recording of Consent for Anaesthesia for Elective Caesarean Section

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?

Study Overview

• Status: Completed
• Conditions: Caesarean Section; Anesthesia
• Intervention / Treatment: Other: Audio-recording of consent for anaesthesia for elective caesarean section

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• maternity patients: antenatal patients before elective caesarean section (5-15 days)
• doctors: anaesthetists who cover labour ward

Exclusion Criteria:

• maternity patients not planning caesarean section
• those booked for elective caesarean section less than a week in advance of the date
• those who do not have the facility to listen to a CD
• those with limited understanding of English
• any woman with a hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Views of patients regarding the acceptability and utility of audio-recording of consent discussions for anaesthesia for elective caesarean section.	Participants' views on the acceptability and utility of audio-recording of consent discussion for anaesthesia for elective caesarean section will be established using questionnaires completed immediately after the recorded discussion and again within the 48 hours following their caesarean section. The questions will include numeric rating scales, with participants required to indicate how strongly they agree/disagree with, and how positively/negatively they feel about a number of statements (where 1 = strongly agree/very positive and 10 = strongly disagree/very negative).	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Views of doctors regarding the acceptability and utility of audio-recording of consent discussions for anaesthesia for elective caesarean section.	The views of doctors involved in audio-recording of consent discussions will be sought on completion of the trial using a questionnaire.The questions will include numeric rating scales, with participants required to indicate how strongly they agree/disagree with, and how positively/negatively they feel about a number of statements (where 1 = strongly agree/very positive and 10 = strongly disagree/very negative).	Up to 6 months
Perceived concerns and/or practical obstacles to overcome in the trial of concept	Questionnaires given to patients and doctors involved in the trial will ask specifically about any concerns and practical obstacles that they feel need to be overcome.The questions will include numeric rating scales, with participants required to indicate how strongly they agree/disagree with, and how positively/negatively they feel about a number of statements (where 1 = strongly agree/very positive and 10 = strongly disagree/very negative).	Up to 6 months

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Investigators: Principal Investigator: Steve Yentis, Chelsea and Westminster Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2018
• Primary Completion (ACTUAL): January 29, 2019
• Study Completion (ACTUAL): January 29, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: C&W18/033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No