NCT04272905

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

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

July 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 6, 2020

Last Update Submit

February 14, 2020

Conditions

Keywords

KnowledgeAttitudesRecordingMaternity

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Data analysis will be completed and reported within an average of one year.

Study Arms (2)

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

Other: Non-interventional study

Maternity Unit Staff

* Doctors, midwives and other staff * Work on labour ward

Other: Non-interventional study

Interventions

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 StaffMaternity patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As above.

You may qualify if:

  • \> 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, Greater London, SW10 9NH, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 24630697BACKGROUND
  • NHS Protect. Patients recording NHS staff in health and social care settings. 2016.

    BACKGROUND
  • Care Quality Commission. Thinking about using a hidden camera or other equipment to monitor someone's care. 2015.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Ursula McHugh, MB BCh BaO

    Chelsea and Westminster NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 17, 2020

Study Start

July 5, 2019

Primary Completion

November 12, 2019

Study Completion

December 18, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations