General practice organ donation intervention: a feasibility study
| ISRCTN | ISRCTN44530504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44530504 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 22/09/2017
- Registration date
- 26/09/2017
- Last edited
- 13/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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?
A large GP Practice in Luton, 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
Contact information
Scientific
University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom
| Phone | +44 (0)1582 743797 |
|---|---|
| gurch.randhawa@beds.ac.uk |
Public
University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom
| catrin.jones1@study.beds.ac.uk |
Scientific
University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom
| Phone | +44 (0)1582 489056 |
|---|---|
| chris.papadopoulos@beds.ac.uk |
Study information
| Study design | Single-centre feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format. Only patients at the designated practice can participate. |
| Scientific title | Investigating an organ donation intervention in primary care: a single-practice feasibility study |
| Study acronym | GPOD |
| Study objectives | To develop and evaluate the feasibility of a GP practice-based intervention designed to increase organ donation rates in ethnically diverse locations. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 16/10/2016 |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | One UK primary care clinic which has already been recruited |
| Key inclusion criteria | 1. 18 years of age or above 2. Capacity to consent to the NHS ODR |
| Key exclusion criteria | 1. Lacks capacity to consent to be a member of the NHS ODR 2. Under 18 years of age |
| Date of first enrolment | 08/01/2018 |
| Date of final enrolment | 09/07/2018 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
United Kingdom
Sponsor information
University/education
University Square
Luton
LU1 3JU
England
United Kingdom
| Website | https://www.beds.ac.uk/research-ref/ihr |
|---|---|
"ROR" |
https://ror.org/0400avk24 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- National Health Service Blood and Transplant, UK National Health Service Blood and Transplant, NHSBT
- Location
- United Kingdom
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/11/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/09/2019: The intention to publish date has been changed from 30/09/2019 to 30/09/2020.
01/08/2019: The following changes were made to the trial record:
1. The trial participating centre name was anonymised to protect identity of participants
2. The plain English summary was updated to reflect these changes.
22/11/2018: Publication reference added.
10/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 09/04/2018 to 09/07/2018.
2. The overall trial end date was changed from 30/09/2019 to 30/09/2018.
3. The ethics approval details were added.
