- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272905
Recording by Patients and Relatives/Friends in the Maternity Unit
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Greater London
-
London, Greater London, United Kingdom, SW10 9NH
- Chelsea and Westminster Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Maternity patients
|
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.
|
Maternity Unit Staff
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Cross-sectional design: Participants are expected to be in the study for 15 minutes approx.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Data analysis will be completed and reported within an average of one year.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ursula McHugh, MB BCh BaO, Chelsea and Westminster Hospital NHS Foundation Trust
Publications and helpful links
General 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.
- NHS 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C&W 19/016
- 258908 (Other Identifier: Integrated Research Application System (IRAS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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