Plain English Summary
Background and study aims
This study aims to find out whether UK primary care is a feasible location for an intervention to increase registration to the NHS Organ Donor Register (NHS ODR). Currently, only 35% of the UK population are on the NHS ODR and there is a shortage of donated organs. Previous research in primary care in the USA shows that the setting may be promising for increasing membership to the register by asking patients if they would like to join during consultations. However, there are barriers to the implementation of primary care interventions in the UK, for example increasing workload. This study therefore assesses whether UK primary care is an appropriate setting for an organ donation intervention.
Who can participate?
Patients aged 18 and over at the participating GP practice in Luton (UK)
What does the study involve?
The intervention consists of three elements: training staff in organ donation information, the display of leaflets and posters in the waiting room and asking patients during consultations if they wish to join the register. The intervention runs for a three-month period. To examine the feasibility of the intervention, the training is evaluated through a survey, data on registrations is collected throughout the study, focus groups are carried out with staff and patients, and staff complete an online survey.
What are the possible benefits and risks of participating?
There are few risks to taking part in the study. However, discussions may involve the topic of organ donation and death, which some people might find difficult.
Where is the study run from?
Medici Medical Practice (UK)
When is the study starting and how long is it expected to run for?
October 2016 to September 2018
Who is funding the study?
1. NHS Blood and Transplant (UK)
2. University of Bedfordshire (UK)
Who is the main contact?
1. Prof. Gurch Randhawa (scientific)
gurch.randhawa@beds.ac.uk
2. Miss Catrin Jones (public)
catrin.jones1@study.beds.ac.uk
3. Dr Chris Papadopoulos (scientific)
chris.papadopoulos@beds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gurch Randhawa
ORCID ID
Contact details
University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom
+44 (0)1582 743797
gurch.randhawa@beds.ac.uk
Type
Public
Additional contact
Miss Catrin Jones
ORCID ID
Contact details
University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom
-
catrin.jones1@study.beds.ac.uk
Type
Scientific
Additional contact
Dr Chris Papadopoulos
ORCID ID
Contact details
University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom
+44 (0)1582 489056
chris.papadopoulos@beds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2.0
Study information
Scientific title
Investigating an organ donation intervention in primary care: a single-practice feasibility study
Acronym
GPOD
Study hypothesis
To develop and evaluate the feasibility of a GP practice-based intervention designed to increase organ donation rates in ethnically diverse locations.
Ethics approval
1. London – Brent, NHS HRA, Research Ethics Committee, 03/11/2017, ref: 17/LO/1361
2. Institute for Health Research, University of Bedfordshire, Ethics Committee, 20/11/2017, ref: IHREC800
3. Confidentiality Advisory Group, HRA, 08/12/2017, ref: 17/CAG/0169
4. Health Research Authority Approval, 11/12/2017
Study design
Single-centre feasibility study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format. Only patients at the designated practice can participate.
Condition
Registration as an organ donor on the NHS Organ Donor Register
Intervention
The intervention consists of three elements, training staff in organ donation information, the display of leaflets and posters in the waiting room and asking patients during consultations if they wish to join the register (also called prompted-choice). A single GP practice in Luton, UK has agreed to run the intervention for a three-month period. To examine feasibility, training will be evaluated through paper survey, data on registrations captured throughout the trial period, focus groups with staff and patients and an online staff survey will be used.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Feasibility of the intervention, assessed using the number of registrations and how often patients are asked the question, collected throughout the intervention period (3 months)
Secondary outcome measures
Due to the mixed methods nature of the study and need to assess feasibility, no secondary outcome measures will be examined
Overall trial start date
16/10/2016
Overall trial end date
30/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years of age or above
2. Capacity to consent to the NHS ODR
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
One UK primary care clinic which has already been recruited
Participant exclusion criteria
1. Lacks capacity to consent to be a member of the NHS ODR
2. Under 18 years of age
Recruitment start date
08/01/2018
Recruitment end date
09/07/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medici Medical Practice
LU1 3UA
United Kingdom
Sponsor information
Organisation
University of Bedfordshire
Sponsor details
University Square
Luton
LU1 3JU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
NHS Blood and Transplant
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Funder name
University of Bedfordshire
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
There are no plans to share additional documents at this time, due to their use to support a PhD. However, there are plans to publish the protocol within the next year.
The results of this study will be disseminated through planned publication in a high-impact peer review journal approximately one year following trial end date. This study forms part of a PhD thesis which will also be published via Ethos.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30459960