Recording by Patients and Relatives/Friends in the Maternity Unit

February 14, 2020 updated by: Chelsea and Westminster NHS Foundation Trust

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

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

As above.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
  • Doctors, midwives and other staff
  • Work on labour ward
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ursula McHugh, MB BCh BaO, Chelsea and Westminster Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2019

Primary Completion (Actual)

November 12, 2019

Study Completion (Actual)

December 18, 2019

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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