Condition category
Neonatal Diseases
Date applied
07/03/2019
Date assigned
09/04/2019
Last edited
09/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One in eight babies born in the UK are too unwell to go home and need to stay in hospital on a neonatal unit. This is stressful for parents, who rely on neonatal staff for updates about their baby, and often feel they aren’t involved in their baby’s care. Parents usually receive written information at the beginning of their baby’s stay and at the end, but are hardly ever given written information about their baby during the neonatal stay. All neonatal units in the UK use an electronic patient record system (EPR): a form of computerised medical notes. Doctors and nurses use this to record a lot of information about babies each day, such as their weight, amount of milk they took and any breathing support they needed. The researchers want to improve how parents receive information, and how involved they feel in their baby’s care, by regularly sharing some of this information with them in a way that is easy to understand. They want to give every parent a daily printed summary of their baby’s information, taken from the electronic system. They have designed this with parents of babies that needed neonatal care and now want to test it on a neonatal unit.

Who can participate?
Parents of babies who are receiving care on the neonatal unit

What does the study involve?
Parents are asked some basic details about themselves and their baby. Then they are given a printed summary sheet containing updates about their baby (‘My Baby’s Summary Report’) every morning on the unit on weekdays (Monday to Friday). Parents are asked to complete an anonymous questionnaire before they start receiving the summaries and then twice a week until their baby is discharged. This includes questions on how they feel about how they receive their baby’s information and how involved they feel in their baby’s neonatal care. It also includes questions on how to further improve the content, layout and wording of the summaries. The summaries are tested on the neonatal unit over 2 months, moving from the lower intensity unit area to the highest. The number of times parents are asked to complete the questionnaire depends on how long their baby is likely to stay on the unit and which unit area their baby is in at the time of recruitment. Parent involvement ends when babies are discharged from the unit. At the same time points of distributing the parent questionnaire (twice weekly) the researchers distribute a three-question staff survey to all neonatal staff on duty in the respective unit areas ( to assess staff workload). Data completeness and accuracy is also assessed at the start of the study and every day by comparing EPR-recorded data to handwritten nursing documentation. Finally, one-on-one interviews are conducted with staff members and parents before the researchers start sharing the summaries with parents and after the piloting stage of the project has finished.

What are the possible benefits and risks of participating?
It is not thought that there are any risks or disadvantages of taking part in this study. It is hoped that the written summaries will improve parents’ understanding of their baby’s condition and their neonatal experience in general. Parent involvement will also help improve the summaries for use by future parents.

Where is the study run from?
Chelsea and Westminster Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2018 to March 2019

Who is funding the study?
1. National Institute for Health Research (NIHR) (UK)
2. Rosetrees Trust (UK)

Who is the main contact?
Dr Susanna Sakonidou
s.sakonidou@imperial.ac.uk

Trial website

http://neoepoch.com/parent-involvement/

Contact information

Type

Public

Primary contact

Dr Susanna Sakonidou

ORCID ID

http://orcid.org/0000-0003-1639-8669

Contact details

Imperial College London Academic Neonatal Medicine
Chelsea and Westminster hospital Campus
Floor 4
lift bank D
369 Fulham road
London
SW10 9NH
United Kingdom
+44 (0)2033153510
s.sakonidou@imperial.ac.uk

Type

Scientific

Additional contact

Dr Susanna Sakonidou

ORCID ID

Contact details

Imperial College London Academic Neonatal Medicine
Chelsea and Westminster hospital Campus
Floor 4
lift bank D
369 Fulham road
London
SW10 9NH
United Kingdom
+44 (0)2033153510
s.sakonidou@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Protocol v1.3/ Sponsor ref 18HH4522

Study information

Scientific title

Better Use of Data to improve parent Satisfaction (BUDS): a mixed method project using qualitative and improvement science methodology to improve parent experience of neonatal care

Acronym

BUDS

Study hypothesis

Having a baby that requires neonatal care is stressful and traumatic for parents, who often report dissatisfaction with communication of clinical infant information. A large percentage of parents in neonatal care experience post traumatic stress disorder, anxiety and depression, which interferes with parent-child bonding and affects infant outcomes. Doctors and nurses routinely record neonatal daily data onto an electronic patient record system (EPR) in the UK, from which de-identified data form a research database: the National Neonatal Research Database (NNRD). The aim of this study to evaluate the impact of sharing neonatal EPR data with parents in neonatal care, on parent–reported satisfaction, parent interactions with staff, staff workload and NNRD data completeness.

Hypothesis: Sharing individualised, daily, clinical electronic patient record infant data with parents, in a parent-centred way, will lead to higher parent-reported satisfaction with communication of clinical information and involvement in neonatal care, and higher data completeness in the National Neonatal Research Database.

Ethics approval

Approved 21/06/2018, amendment submitted 23/11/2018 and approved 12/12/2018, West Midlands - South Birmingham REC, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS. Email: NRESCommittee.WestMidlands-SouthBirmingham@nhs.net, REC ref: 18/WM/0175, Protocol number: Sponsor ref 18HH4522, IRAS project ID: 232205

Study design

Prospective mixed method study using qualitative and improvement science methodology

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Neonatal care

Intervention

Through qualitative work with parents of babies previously needing UK neonatal care, the researchers identified the type of infant information parents find important in neonatal care. They matched this information to the available EPR infant data items neonatal staff update daily throughout the UK and developed parent-friendly EPR data explanations. With parents, they co-designed a communication tool template for parents called “My Baby’s Summary Report”: a printed sheet of paper including individualised, daily infant updates for parents derived from EPR data, in parent-centred language. They will provide an individualised written summary report to each parent on weekdays. This will initially be offered to parents in the low-intensity neonatal unit area (Special Care Baby Unit) before expanding to approach all parents (High Dependency Unit and Intensive Care Unit). The communication tool’s impact will be measured and Plan-Do-Study-Act (PDSA) improvement science cycles will inform the tool’s continual improvement.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Parent satisfaction with communication of clinical information and involvement in care, assessed using validated self-administered parent questionnaire, the Parents' Experiences of Communication in Neonatal Care (PEC) questionnaire at baseline, twice weekly and at the end of piloting phase.

Secondary outcome measures

1. Parent interactions with staff, assessed with PEC questionnaire at baseline, twice weekly and at the end of piloting phase
2. Neonatal staff workload, assessed with self-administered staff questionnaire at baseline, twice weekly and at the end of piloting phase
3. Data completeness, assessed using historical completeness data from the National Neonatal Research Database and current completeness data from the live neonatal EPR at baseline, every day and at the end of piloting phase
4. Parent/staff interaction and parental views on information communication assessed with one-on-one interviews with parents and staff at baseline and at end of piloting phase

Overall trial start date

04/06/2018

Overall trial end date

02/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parents (male or female) of babies who are currently inpatients on the neonatal unit
2. The parental age lower limit will be 16 years
3. The researchers will start recruiting parents with babies in the lower intensity part of the unit (SCBU- Special Care Baby Unit) who are medically stable and not acutely unwell, in order to minimise the risk of causing anxiety to parents
4. They will recruit parents in SCBU only for 4 weeks, include High Dependency Unit parents in recruitment for 2 weeks and include Intensive Care Unit parents in the final 2 weeks

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

Maximum 90

Participant exclusion criteria

1. Parents who cannot speak and/or read English will be excluded as the study’s information documents and communication tool are in English
2. Parents younger than 16 years of age

Recruitment start date

08/10/2018

Recruitment end date

05/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chelsea and Westminster Hospital NHS Foundation Trust
369 Fulham Road
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Faculty of Medicine centre
215
2nd Floor
Norfolk Place
St Mary's Campus
London
W2 1PG
United Kingdom
+44 (0)20 7594 9459
becky.ward@imperial.ac.uk

Sponsor type

University/education

Website

https://www.imperial.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

Rosetrees Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers will disseminate their results through Bliss: for babies born premature or sick (The National Charity for the Newborn UK), conferences and peer-reviewed journals. Their future work will aim to incorporate their findings into a mobile phone application for efficiency and wider generalizability, with a view to roll out to all NHS neonatal units.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Chris Gale (christopher.gale@imperial.ac.uk). Type of data: anonymised, coded data (no free text). When the data will become available and for how long: After study results published and indefinitely. By what access criteria data will be shared including with whom: For research purposes and following review of individual requests. For what types of analyses and by what mechanism: Anonymised analyses reviewed on case by case basis. Whether consent from participants was obtained: Only anonymised data will be shared and consent was obtained for this. Extract from consent form: "I understand all data collected during the project, may be looked at by individuals from the sponsor (Imperial College London JRCO), NHS and regulatory authorities where it is relevant for regulatory purposes, as well as by approved researchers." Comments on data anonymisation: Only coded datam no free text.

Intention to publish date

01/07/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/03/2019: Trial's existence confirmed by West Midlands - South Birmingham Research Ethics Committee and HRA and Health and Care Research Wales.