Caesarean SectionNCT04238741
Audio-recording of Consent for Anaesthesia for Elective Caesarean Section
A study testing Audio-recording of consent for anaesthesia for elective caesarean section in people with Caesarean Section and Anesthesia, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section, Anesthesia
- What is being tested?
- Audio-recording of consent for anaesthesia for elective caesarean section
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2018to 29 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- maternity patients: antenatal patients before elective caesarean section (5-15 days)
- doctors: anaesthetists who cover labour ward
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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?
Read the 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.
- Conditions
- Caesarean Section, Anesthesia
- Being tested
- Audio-recording of consent for anaesthesia for elective caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: 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).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start25 Sep 2018
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Yentis, Principal investigator, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238741
- Sponsor's protocol ID
- C&W18/033
- Status last verified
- Jan 2020
- First submitted
- 6 Nov 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio-recording of Consent for Anaesthesia for Elective Caesarean Section - a Pilot Study
- ClinicalTrials.gov ID
- NCT04238741
- Acronym / sponsor ID
- C&W18/033
- Conditions
- Caesarean Section, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- maternity patients: antenatal patients before elective caesarean section (5-15 days)
- doctors: anaesthetists who cover labour ward
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-recording of consent for anaesthesia for elective caesarean sectionAntenatal 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. | Other | – |
Primary outcome
Views of patients regarding the acceptability and utility of audio-recording of consent discussions for anaesthesia for elective caesarean section.
Time frame: Up to 6 months
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).
2 secondary outcomes
Views of doctors regarding the acceptability and utility of audio-recording of consent discussions for anaesthesia for elective caesarean section.
Time frame: Up to 6 months
Perceived concerns and/or practical obstacles to overcome in the trial of concept
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Yentis principal investigator
Chelsea and Westminster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-recording of consent for anaesthesia for elective caesarean section in people with Caesarean Section and Anesthesia, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Views of patients regarding the acceptability and utility of audio-recording of consent discussions for anaesthesia for elective caesarean section. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.