ISRCTN ISRCTN36338010
DOI https://doi.org/10.1186/ISRCTN36338010
IRAS number 233611
Secondary identifying numbers 40177, IRAS 233611
Submission date
21/01/2019
Registration date
23/01/2019
Last edited
17/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
This study aims to raise awareness and encourage discussions between colleagues, friends and family members around organ donation. Although 90% of the UK population agree with organ donation in principle, a staff survey revealed that less than 1 in 3 NHS staff in Teesside had discussed their thoughts with their friends/family and signed up to the organ donation register. Even if England moves to an opt out system for organ donation knowledge of a loved one's wishes can support the family during a very difficult time. This study aims to increase discussions about organ donation in a conversational manner.

Who can participate?
This pilot study will take place at South Tees Hospitals NHS Foundation Trust and all staff who attend basic life support training will be invited to participate.

What does the study involve?
The researchers have created a short video to highlight the importance of talking about organ donation. Staff will be invited to answer a short questionnaire before watching the video about their feelings towards organ donation and another following the film sent 3-5 working days after the training. After the second questionnaire participants who are willing to discuss how they felt about the video may be asked to take part in a longer interview.

What are the possible benefits and risks of participating?
There is no immediate benefit to the research participants. The aim of this study is to ascertain if we can use a film intervention to encourage people to talk to their families about organ donation, which in turn may increase the sign up to the organ donation register. This would have a potential benefit to everyone who needs an organ in the future. There are no anticipated risks to participants as this is a questionnaire/interview based study. A potential burden for participants is the completion of the questionnaires and a possible interview. The first questionnaire is paper based, the second is web-based and the link will be emailed to participants. These questionnaires will only take 2-5 minutes. Any participant who is willing to be interviewed will be interviewed at a time and place convenient to them so that it minimises any potential burden.

Where is the study run from?
South Tees Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2016 to June 2020

Who is funding the study?
1. Northern Counties Kidney Research Fund
2. Teesside Extra Life
3. Principle Sounds

Who is the main contact?
Dr Caroline Wroe
caroline.wroe@nhs.net

Contact information

Ms Alycon Walker
Public

STRIVE Academic Centre @South Tees Hospitals NHS Foundation Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone +44 (0)1642 854092
Email alycon.walker@nhs.net
Dr Caroline Wroe
Public

Renal Unit
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

ORCiD logoORCID ID 0000-0001-6909-7726
Phone +44 (0)1642 852483
Email caroline.wroe@nhs.net

Study information

Study designNon-randomised; Both; Design type: Process of Care, Education or Self-Management, Psychological & Behavioural, Qualitative
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA study to evaluate the feasibility and impact of introducing organ donation awareness into Basic Life Support training in an NHS Acute Hospital Trust
Study objectivesTo determine if a short film introduced at the end of BLS training can positively influence people's thoughts and conversations about organ donation.
Ethics approval(s)Current ethics approval as of 13/11/2019:
Approved 03/01/2019, HRA and Health and Care Research Wales (hra.approval@nhs.net), ref: 233611

Previous ethics approval:
Not provided at time of registration
Health condition(s) or problem(s) studiedOrgan donation awareness
InterventionThe trialists have created a short video to highlight the importance of talking about organ donation. This pilot study will take place at South Tees Hospitals NHS Foundation Trust and all staff who attend basic life support training training will be invited to participate. Staff will be invited to answer a short questionnaire prior to the video about their feelings towards organ donation and another following the film sent 3-5 working days after the training. After the second questionnaire participants who are willing to discuss how they felt about the video may be asked to take part in a longer interview.
Intervention typeBehavioural
Primary outcome measureThe number of participants who following the intervention have:
1. Spoken about organ donation with a friend or family member
2. Discussed their wishes about if they would want to donate their organs after death with a family member or friend
3. Feel more positive about organ donation after the intervention
This will measured via a questionnaire at the beginning of the BLS session and a questionnaire sent 3-5 working days after viewing the organ donation video.
Secondary outcome measuresThe number of staff overall who engage with the research project. This will be measured by documenting the number of people attending the BLS session against the number of people who submitted the questionnaire at the beginning of the BLS session and completed the follow-up questionnaire 3-5 working days after watching the organ donation video.
Overall study start date01/01/2016
Completion date28/06/2020

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 180; UK Sample Size: 180
Total final enrolment283
Key inclusion criteriaAll members of staff at South Tees NHS Foundation Trust who attend basic life support training during the study period
Key exclusion criteriaAny staff under the age of 18
Date of first enrolment28/01/2019
Date of final enrolment28/04/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

South Tees Hospitals NHS Foundation Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

South Tees Hospitals NHS Foundation Trust
Hospital/treatment centre

c/o Joe Millar (Research and Development Manager)
South Tees Institute of Learning, Research and Innovation
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom

Phone +44 (0)1642 854089
Email stees.researchdevelopment@nhs.net
ROR logo "ROR" https://ror.org/02js17r36

Funders

Funder type

Charity

Northern Counties Kidney Research Fund
Private sector organisation / Other non-profit organizations
Alternative name(s)
NCKRF
Location
United Kingdom
Teesside Extra Life

No information available

Principle Sounds

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Preprint results 09/12/2020 17/03/2022 No No

Editorial Notes

17/03/2022: Preprint reference added.
16/06/2021: The intention to publish date has been changed from 31/12/2020 to 31/12/2021.
11/06/2020: The intention to publish date has been changed from 31/12/2019 to 31/12/2020.
13/11/2019: The following changes have been made:
1. The ethics approval information has been added.
2. The IRAS number has been added.
15/08/2019: Contact details updated.
17/05/2019: The following changes have been made:
1. The final enrolment number has been added.
2. The intention to publish date has been changed from 28/01/2020 to 31/12/2019.
25/03/2019: The condition has been changed from "Specialty: Health Services Research, Primary sub-specialty: Health Services Research; Health Category: Generic health relevance" to "Organ donation awareness" following a request from the NIHR.