Condition category
Not Applicable
Date applied
22/09/2017
Date assigned
26/09/2017
Last edited
26/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 2019

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. NHS Research Ethics Committee - London Brent, ref: 17/LO/1361 - approval pending
2. University of Bedfordshire Research Ethics Committee - approval pending

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 measures

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

30/09/2019

Reason abandoned

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

09/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medici Medical Practice
LU1 3UA

Sponsor information

Organisation

University of Bedfordshire

Sponsor details

University Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

https://www.beds.ac.uk/research-ref/ihr

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

30/09/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes