Knowledge, Attitudes, PracticeNCT04272905
Recording by Patients and Relatives/Friends in the Maternity Unit
An observational study of Knowledge, Attitudes, Practice and Maternity, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Increasingly, patients are keen to record aspects of their medical care, especially in obstetrics and paediatrics. The knowledge of patients and staff in relation to this area is thought to be variable. In addition, the attitudes of patients and staff regarding this practice has not been well studied. 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
- Knowledge, Attitudes, Practice, Maternity, Health Personnel Attitude
- What is being tested?
- Non-interventional study
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2019to 18 Dec 2019
- Phase
- Observational
- 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
Study population: As above.
Who may be able to join
- > 18 years
- Post natal following any form of delivery
- Between 4 and 48 hours after delivery
- Able to understand English adequately to give consent and complete the questionnaire
Who cannot join
- Women experiencing complications affecting themselves or their babies will be excluded if it is felt that approaching them for potential recruitment might be overly intrusive.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital
London, Greater London, SW10 9NH
About this study
Official title: Recording by Patients and Relatives/Friends in the Maternity Unit - Patient and Staff Knowledge/Attitudes
Increasingly, patients are keen to record aspects of their medical care, especially in obstetrics and paediatrics. The knowledge of patients and staff in relation to this area is thought to be variable. In addition, the attitudes of patients and staff regarding this practice has not been well studied. This study aims to gather information on patients' use of recording devices to capture audio recordings, photographs or videos. Furthermore it aims to assess patient and staff knowledge and attitudes in relation to this area.
This study will involve patients who have recently delivered a baby on the maternity unit or obstetric theatre completing a questionnaire. They will be approached by a study investigator and the study explained. They will then complete a consent form if they are happy to proceed. Following this they will complete the questionnaire.
It will also involve the surveying of staff, who will be approached by a study investigator when not directly involved in the clinical care of patients. They will also complete a consent form if they are happy to proceed and then complete the questionnaire.
Read the detailed description
The aim of the study is to evaluate the knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the obstetric environment.
- Being tested
- Non-interventional study
- Keywords
- Knowledge, Attitudes, Recording, Maternity
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
The participants will be asked to complete a questionnaire on their knowledge of, and attitudes towards the recording of patient care by patients or relatives/friends in the maternity unit. An investigator will be immediately available to facilitate completion of the survey and assist with understanding of the questions. The data recorded will be a mixture of nominal data (selections from a number of options using a tickbox) or ordinal (as above, but graded e.g. yes / yes with qualifiers / no). Free text will be coded and presented as nominal data or presented verbatim to illustrate points that arise.
| Study group | Role | What they receive |
|---|---|---|
| Maternity patients | * > 18 years
* Post-natal following any form of delivery
* Between 4 and 48 hours after delivery
* Able to understand English adequately to give consent and complete the questionnaire Receives: Other: Non-interventional study | |
| Maternity Unit Staff | * Doctors, midwives and other staff
* Work on labour ward Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the maternity unit and obstetric theatre environment.
Staff and patients will be asked to complete an unvalidated questionnaire titled "Recording by patients and relatives/friends in the maternity unit", which is expected to take 10-15 minutes to complete. Please note that one questionnaire has been adapted for patients and another one for staff. Both contain 4 sections. The sections in the patients' questionnaire are: Background, Your experience of recording, Guidelines on recording and Your opinions regarding recording. The sections in the staff's questionnaire are: Background, Your experience of recording, Knowledge and Attitudes.
Data will be presented using descriptive statistics: Number (%) ± 95% CI for nominal data and median (IQR [range]) for ordinal data as appropriate.
Measured: Cross-sectional design: Participants are expected to be in the study for 15 minutes approx.
Secondary outcomes (1)
Group differences between the knowledge and attitudes of patients and staff regarding what is acceptable to record and appropriate uses of recordings.
Analytic statistics will be performed to compare differences in the results of the unvalidated questionnaire between the two groups (patients and staff) using the chi-squared/Fisher's exact test for nominal data and Mann-Whitney U-test for ordinal data, taking p < 0.05 to denote statistical significance.
Measured: Data analysis will be completed and reported within an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start5 Jul 2019
- Primary completion12 Nov 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursula McHugh, MB BCh BaO, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272905
- Sponsor's protocol ID
- C&W 19/016
- Other IDs
- 258908
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsulukidze M, Durand MA, Barr PJ, Mead T, Elwyn G. Providing recording of clinical consultation to patients - a highly valued but underutilized intervention: a scoping review. Patient Educ Couns. 2014 Jun;95(3):297-304. doi: 10.1016/j.pec.2014.02.007. Epub 2014 Mar 3.
PubMed 24630697NHS Protect. Patients recording NHS staff in health and social care settings. 2016.
Care Quality Commission. Thinking about using a hidden camera or other equipment to monitor someone's care. 2015.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording by Patients and Relatives/Friends in the Maternity Unit - Patient and Staff Knowledge/Attitudes
- ClinicalTrials.gov ID
- NCT04272905
- Acronym / sponsor ID
- C&W 19/016
- Keywords
- Knowledge, Attitudes, Recording, Maternity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 17 Feb 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.
Increasingly, patients are keen to record aspects of their medical care, especially in obstetrics and paediatrics. The knowledge of patients and staff in relation to this area is thought to be variable. In addition, the attitudes of patients and staff regarding this practice has not been well studied. This study aims to gather information on patients' use of recording devices to capture audio recordings, photographs or videos. Furthermore it aims to assess patient and staff knowledge and attitudes in relation to this area.
This study will involve patients who have recently delivered a baby on the maternity unit or obstetric theatre completing a questionnaire. They will be approached by a study investigator and the study explained. They will then complete a consent form if they are happy to proceed. Following this they will complete the questionnaire.
It will also involve the surveying of staff, who will be approached by a study investigator when not directly involved in the clinical care of patients. They will also complete a consent form if they are happy to proceed and then complete the questionnaire.
Detailed description
The aim of the study is to evaluate the knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the obstetric environment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternity patients | – | Other: Non-interventional study* > 18 years * Post-natal following any form of delivery * Between 4 and 48 hours after delivery * Able to understand English adequately to give consent and complete the questionnaire |
| Maternity Unit Staff | – | Other: Non-interventional study* Doctors, midwives and other staff * Work on labour ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As above.
Key inclusion criteria (4 listed)
- > 18 years
- Post natal following any form of delivery
- Between 4 and 48 hours after delivery
- Able to understand English adequately to give consent and complete the questionnaire
Key exclusion criteria (1 listed)
- Women experiencing complications affecting themselves or their babies will be excluded if it is felt that approaching them for potential recruitment might be overly intrusive.
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 |
|---|---|---|
| Non-interventional studyThe participants will be asked to complete a questionnaire on their knowledge of, and attitudes towards the recording of patient care by patients or relatives/friends in the maternity unit. An investigator will be immediately available to facilitate completion of the survey and assist with understanding of the questions. The data recorded will be a mixture of nominal data (selections from a number of options using a tickbox) or ordinal (as above, but graded e.g. yes / yes with qualifiers / no). Free text will be coded and presented as nominal data or presented verbatim to illustrate points that arise. | Other | Maternity Unit Staff, Maternity patients |
Primary outcome
Knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the maternity unit and obstetric theatre environment.
Time frame: Cross-sectional design: Participants are expected to be in the study for 15 minutes approx.
Staff and patients will be asked to complete an unvalidated questionnaire titled "Recording by patients and relatives/friends in the maternity unit", which is expected to take 10-15 minutes to complete. Please note that one questionnaire has been adapted for patients and another one for staff. Both contain 4 sections. The sections in the patients' questionnaire are: Background, Your experience of recording, Guidelines on recording and Your opinions regarding recording. The sections in the staff's questionnaire are: Background, Your experience of recording, Knowledge and Attitudes. Data will be presented using descriptive statistics: Number (%) ± 95% CI for nominal data and median (IQR [range]) for ordinal data as appropriate.
1 secondary outcome
Group differences between the knowledge and attitudes of patients and staff regarding what is acceptable to record and appropriate uses of recordings.
Time frame: Data analysis will be completed and reported within an average of one year.
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 17 Feb 2020.
- Background: PubMed 24630697Tsulukidze M, Durand MA, Barr PJ, Mead T, Elwyn G. Providing recording of clinical consultation to patients - a highly valued but underutilized intervention: a scoping review. Patient Educ Couns. 2014 Jun;95(3):297-304. doi: 10.1016/j.pec.2014.02.007. Epub 2014 Mar 3.
- BackgroundNHS Protect. Patients recording NHS staff in health and social care settings. 2016.
- BackgroundCare Quality Commission. Thinking about using a hidden camera or other equipment to monitor someone's care. 2015.
- Recording video has never been so easy or effortlessLink provided by the sponsor.
- The Care Quality Commission discusses using cameras or other recording equipment to check somebody's careLink provided by the sponsor.
- Digital dilemmas - Patients recording consultationsLink provided by the sponsor.
- Photographers Rights And The Law In The UK - The law and photography.Link provided by the sponsor.
- 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.
Ursula McHugh, MB BCh BaO principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knowledge, Attitudes, Practice and Maternity, 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 4 inclusion and 1 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 17 Feb 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?
Knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the maternity unit and obstetric theatre environment. (time frame: Cross-sectional design: Participants are expected to be in the study for 15 minutes approx.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272905, which also lists 3 linked publications.
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 17 Feb 2020.