Research

Volunteer recruitment for vaccine studies by Newcastle Hospitals: GP practice request

Newcastle Hospitals are recruiting to Covid19 vaccine studies over the next 6 months. We are working with the Trust on this project and are asking GP practices to participate.

Recruitment needs to be rapid when studies open so it is important to create registers of volunteers in advance.  The National NIHR vaccine registry has been modestly successful but many individuals prefer local NHS contact.  We propose using the Research+Me registry which is managed by Newcastle Hospitals, working closely with GP practices across the city.

We are asking practices to consider text-outs to adult patients offering a link for registration to the Research+Me registry to help with volunteer recruitment.  Payment is available to practices as follows: a) for providing the text-out, b) a randomisation fee for any patients recruited to vaccine studies and c) randomisation fees for any subsequent studies.

Research+Me: This is a generic trial registry run by Newcastle Hospitals Patient Recruitment Centre (PRC).  It is a cloud based system (REDCap) with appropriate information governance security.  Data on the registry is never shared with third parties.  Contact with registrants is via an email with appropriate ethics-approved trial information.  The webpage has been modified to emphasize vaccine studies and the first page includes an option to register for ‘vaccine only’ or ‘all studies’. 

Patients are likely to remain on the registry long term if they accept “all studies” option (early evidence suggest 2/3 of patients will opt for this).  We are keen that this process feels like a collaboration over the long term so will identify patients registered in this way (as GP registered) and provide ongoing remuneration, where appropriate, in a transparent way.  The system to do this is described below; it will be automated (not dependent on people remembering to do the right thing), transparent and auditable.

Text wording: This can be amended, but please let us know if you wish to change the text.  Examples:

This is from XXXXX XXXX. Newcastle Hospitals are running COVID19 vaccine research & are looking for volunteers.  To find out more sign up to our local Research+Me registry. Sign up is quick, safe and secure. Visit https://bit.ly/31z5WH1

Or even shorter:

This is from XXXXX XXXX. Newcastle Hospitals are running COVID19 vaccine research & are looking for volunteers.  To find out more sign up to our local Research+Me registry. Visit https://bit.ly/31z5WH1

Payments: Payment for sending out texts will be £50 per practice (provided by NENC CRN).  We are looking to have two identical texts sent one week apart.

There will also be a randomisation fee for every GP-registered participant recruited to every trial (this means all future trials – long term – not just vaccine trials).  Randomisation fees will be negotiated with sponsors and related to trial intensity and target.  An intense study requiring two recruits may claim a fee of £200; a vaccine study with many hundreds recruited would generate £10-£20 per participant.  Our next vaccine trial is the Janssen study and we have negotiated a £20 pp randomisation fee.  We have provisional agreement to provide these fees via the PRISM system.

How will you know a patient is GP registeredEach federation has a specific link which will identify registrant as “GP-registered” and provide a drop-down list of practices.  The registrant will simply click on their practice.  Whenever we (PRC) undertake a Research+Me registry mail-out the system will record those recruited to the study and automatically highlight any that are GP-registered.  After each study a report will be generated to show any GP-registered patients that have been recruited.  This report will be shared with NENC CRN Primary Care Research Operations Manager (and anyone else who wants it).  Practices will then be remunerated accordingly.

If you would like more information about this research project please contact Prof Yan Yiannakou on yan.yiannakou@nhs.net or Emily Fisher at NGPS on emily.fisher8@nhs.net