Condition category
Not Applicable
Date applied
21/01/2019
Date assigned
23/01/2019
Last edited
17/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Mrs Jennifer Robinson

ORCID ID

Contact details

Room 12B17
LRI
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 854092
jennifer.robinson22@nhs.net

Type

Public

Additional contact

Dr Caroline Wroe

ORCID ID

http://orcid.org/0000-0001-6909-7726

Contact details

Renal Unit
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 852483
caroline.wroe@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

40177

Study information

Scientific title

A study to evaluate the feasibility and impact of introducing organ donation awareness into Basic Life Support training in an NHS Acute Hospital Trust

Acronym

Study hypothesis

To 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

Not provided at time of registration

Study design

Non-randomised; Both; Design type: Process of Care, Education or Self-Management, Psychological & Behavioural, Qualitative

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Organ donation awareness

Intervention

The 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 type

Behavioural

Phase

Drug names

Primary outcome measure

The 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 measures

The 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 trial start date

01/01/2016

Overall trial end date

28/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All members of staff at South Tees NHS Foundation Trust who attend basic life support training during the study period

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 180; UK Sample Size: 180

Total final enrolment

283

Participant exclusion criteria

Any staff under the age of 18

Recruitment start date

28/01/2019

Recruitment end date

28/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

South Tees Hospitals NHS Foundation Trust

Sponsor details

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
United Kingdom
+44 (0)1642 854089
stees.researchdevelopment@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Northern Counties Kidney Research Fund

Alternative name(s)

NCKRF

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Teesside Extra Life

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Principle Sounds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.