Federating for improvement
Developing research across a Federation of GP practices: Experiences from Lawcy Group in North Somerset
Julie Davidson – Federation research manager
Matt Hoghton – Federation clinical lead
Since 2008, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) in England has operated an incentive scheme for GP practices to support participation in research projects. The Research Site Initiative (RSI) scheme funding enables GP practices to be research active and to undertake study feasibility assessments, Participant Identification Centre (PIC) activity and delivery of studies available via the NIHR CRN portfolio. This funding is in addition to the service support costs for setting studies up at site level and to reimburse patient recruitment costs. There is a similar scheme developed by NISCHR Academic Health Science Collaboration (AHSC) for practices in Wales and in Scotland, NHS Tayside is currently running a pilot, but unfortunately no scheme exists in Northern Ireland.
The incentive scheme run by the CRN in England comprises different levels depending on the number of studies and patients you have recruited in the past year. Experienced practices can apply for additional sessional funding for clinical and administrative staff.
Organisations apply for funding on an annual basis and it is competitive. The CRN aim to invest their funding wisely to ensure research studies have the best chance of success when placed within a practice or federation. Each level of funding places participation requirements on a practice, and carries Key Performance Indicators (KPI's) to achieve, which are measured at six months and the end of the year. The levels of funding are incremental and related to workload involved. The KPIs aim to ensure value for money for CRN support, and include requirements on the numbers of studies practices will need to participate in, acceptable numbers of patient recruitment, research meetings and attendance at an annual, regional, research conferences. Failure to achieve KPIs can result in funding being moved around the practices during the year. Continual funding at the same level year after year is not guaranteed and funding may be reduced so that more practices can be involved.
Requirements for all practices who seek RSI funding in England:
- Research personnel must have 'Good Clinical Practice' (GCP) training (one day course or four hours online now available).
- The practice must be RCGP Research Ready® accredited, through the quality assurance programme available at www.rcgp.org.uk/researchready
- The practice must meet the requirements of the KPIs or funding may be cut at the six or 12 month stage.
To get involved in research as a practice or collectively as a federation, it is important to make early contact with your local CRN support team (see contact details below). After making contact they will provide you with details of the latest available studies that your organisation can recruit to; these will have Health Research Authority (HRA) approval covering ethics, protocols and funding before they are submitted for adoption by your local CCG in England. In our federation we consider the studies collectively and then each practice interested in supporting a study submits an 'expression of interest' form to study teams. If the study team want to enrol patients from our federation area, our practices will be contacted and asked if they still wish to proceed. Withdrawal is possible at this stage. All studies will have target recruitment figures to achieve over a timescale and reimbursement costs are quantified for each element of participation, though most elements are compulsory. The reimbursement costs generally cover the resources spent in practice e.g. letter mailings, nurse consultations.
Development of a practice federation: a research approach
In 2013 our practice formed part of a federation of four practices covering a population of approximately 38,000 patients with one sentinel research practice. It was important to seek an agreement in principle to undertake research in all practices, particularly as there had been little experience of research in three of the practices. Our practice took the role of the sentinel practice, providing support and guidance to others and sharing positive experiences and the benefits of delivering research to our patients. In North Somerset Lawcy group we agreed to develop our research federation by adopting the following approach:
- Each practice nominates a clinical and administrative lead for all research activities with an agreed job description
- One research GP leads the federation research activities and acts as a Principal Investigator for all sites when required for certain studies
- All practices apply for RSI scheme funding and are performance monitored as per CRN requirements on an individual site level
- We spoke with our local CRN to explain the federation opportunity and how we can potentially deliver studies collaboratively through joined-up research teams; and the eventual linkage of clinical systems
- We express interest in studies for the federation and we provide additional details to study teams to facilitate positive selection of the federation above other competing practices
- A lead practice manager will negotiate fees per study for the federation, to ensure service support costs reflect the collaborative approach where duplication can be removed
- A lead practice will raise all invoices centrally and payments will go to the new venture, with transparency of participation levels and income generated by the individual practice's involvement
- Use Hub and spoke model of engagement between the practices
- Create our own business model and KPIs
By 2015 we had all four practices involved in research with several of the practices participating in multiple studies, including one which was industry-based, and achieving higher levels of recruitment in some studies than the sentinel practice.
- For studies which involve setup/screening/mail out/reminders/filing
The lead practice can instruct or do the search on the federating practice's clinical system. Patient screening is completed by local GPs, and a condensed list of eligible patients returned to the lead practice to process mail outs, reminders and filing. Administration can be delivered by the lead practice, but could be rolled out if administration staff elsewhere complete the GCP training and can be trained to complete the work accurately and on time. Invoices (transparent) are raised and paid to the new venture organisation.
- For studies which involve all of option 1 plus patient record reviews
A researcher may need local access to the clinical records system. Visits to participating practices by study researchers must be supported by admin and clinical personnel and rules are followed on what the researcher can access and remove from site. Invoices (transparent) are raised and paid to new venture organisation.
- For studies which involve opportunistic patient recruitment in consultations/plus additional medical records searches
A setup site meeting would be required involving relevant site teams and the study team. Site resources and the implementation plan need to be organised. Communication plans will be necessary to encourage recruitment at participating sites. Patient records reviews may be requested and site visits completed as described above. Invoices (transparent) are raised and paid to new venture organisation.
- For industry studies (feasibility or phase III clinical trials)
We operated a hub and spoke model with lead nurses identified to cover more than one study and have mainly focused on post-marketing research studies.
- Studies vary on income generation and cost of resources to do them.
- There is no guaranteed number of studies available each year.
- There is no guarantee that the populations of all the practices would be required in every study if we were successful with our bidding to be involved.
Why has our practice federation been successful at research?
Key elements to achieve success have been due to the following:
- The resources are in place to deliver research from a qualified team of staff.
- Research activities are prioritised and professionally managed to develop more research opportunities.
- We built a successful reputation with involvement in many studies with good contributions.
- We expressed an interest in every study in the last three years.
- We followed each study's rules, gave feedback to study teams, hit every deadline and ensured we supported study teams when they asked for our help.
- We identified our models of delivery for each study to achieve efficient processes and successful recruitment in all studies.
- We try to become the 'highest recruiters' in some studies on the regular CRN bulletin.
- We petitioned our local CRN contact for more studies
What are our risks?
- A federation may be too big for some studies, thereby reducing income opportunities
- CRN funding cannot be guaranteed
- Turnover of staff
- Poor opportunistic recruitment to some studies in consultations at a practice
- Poor performance on one study can breed a bad reputation and damage the group
- The sentinel practice was well established with a good reputation which was built upon with a federation model
- We have continued to enjoy support from local researchers, the CRN and our patients and their carers
- Adds value to the federative approach in primary care
- We are recognised as an innovative organisation and our patients and patient participation groups value the opportunities provided to our patients to participate in research studies
- We know that health organisations that do research generally improve the quality across their whole organisationsi
The RCGP is now running the Supporting Federations programme, a piece of work which aims to support practices in scaling up into larger general practice organisations, in partnership with the Nuffield Trust and funded by NHS England. If you would like to find out more about this programme, please contact the team at firstname.lastname@example.org.
Contact details for UK CRNs
Contact details for RCGP Research Ready®
i. Hanney S, Boaz A, Jones T, Soper B..Engagement in research: an innovative three-stage review of the benefits for health-care performance. Health Serv Deliv Res 2013;1(8)