NCT04238741

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

November 6, 2018

Last Update Submit

January 22, 2020

Conditions

Caesarean SectionAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Views of doctors regarding the acceptability and utility of audio-recording of consent discussions for anaesthesia for elective caesarean section.

    Up to 6 months

  • Perceived concerns and/or practical obstacles to overcome in the trial of concept

    Up to 6 months

Interventions

Audio-recording of consent for anaesthesia for elective caesarean sectionOTHER

Antenatal women will be invited to attend 5-15 days before their caesarean section for an anaesthetic consent discussion with audio-recording. Participants will complete a questionnaire immediately following the recorded discussion and again within the 48 hours following their surgery, to establish their views on the process of audio-recording of consent and the potential usefulness/acceptability of the audio-recording.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, sw10 9nh, United Kingdom

Location

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Steve Yentis

    Chelsea and Westminster Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

January 23, 2020

Study Start

September 25, 2018

Primary Completion

January 29, 2019

Study Completion

January 29, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)