Primary Care Research Network - East of England. . One of 8 PCRNs across EnglandPart of the National Institute for Health Research (NIHR) family of networksCore team based in NHS CambridgeshireLocality teams across EoE100 studies About 45% of practices in EoE are involved in one of our studie
1. What can the primary care research network offer practices?
2. Primary Care Research Network - East of England One of 8 PCRNs across England
Part of the National Institute for Health Research (NIHR) family of networks
Core team based in NHS Cambridgeshire
Locality teams across EoE
About 45% of practices in EoE are involved in one of our studies
3. PCRN: - Our aim
To support clinical research and to facilitate the conduct of, and trials and other well-designed studies within the NHS.
To increase the number of patients recruited
4. Why is it important ?
Each month, 23 million people (more than three times the population of London) visit their GP surgery or practice nurse
Full-time GPs treat an average of 255 patients a week.
In a typical week, 1.4 million people will receive help in their home from the NHS.
About 35% of all patients involved in NIHR portfolio research have been recruited in primary care
5. Research Agenda for Primary Care The natural history, diagnosis, treatment, and prevention of health conditions seen in primary care settings, including the management of undifferentiated clinical problems as well as long term conditions.
The nature, characteristics, and organization of primary care practice.
Health care decision-making and the relationship between the clinician and the patient in the context of the family and community.
The continuity and coordination of primary care services, including referrals and the interface of primary and specialty care.
(US Agency for Healthcare Research and Quality)
6. NHS Operating Framework 2009/10 ‘High Quality Care for All’ made it clear that innovation must be central to the NHS if we are to improve constantly the quality of care. To achieve this, the NHS must play its full part in supporting health research. All providers of NHS care will need to increase their participation in research.
The national ambition is to double the number of patients taking part in clinical trials and other well-designed research studies within five years.
7. Evidence and practice
8. Evidence and practice
9. Are we ready for research?
10. 3 key concerns
Quality of the studies and fit with clinical practice
Support and facilitation to help practices or services – one
Funding and capacity – need to be realistic
11. Quality: NIHR Portfolio Co-ordinated nationally
Studies with competitive national funding
Local prioritisation for our work
Essential for NIHR support funding
Local feasibility work
Ensuring ethics and NHS permissions are in place
12. Entry level self-accreditation scheme
Is there support within the practice for research activity?
Does the practice have space and facilities to host research?
Can searches of the practice database be carried out?
Do you know what is required of your practice with reference to research governance?
Are you aware of your responsibilities to patients and staff if they are participating in research?
PCRN can assist with this
13. PCRN support and facilitation for practices
Study summary sheets – RISP forms
One port-of-call for troubleshooting
Flexible ways of being involved
This service can lead to high levels of practice participation in research
14. PCRN support and facilitation – flexible ways of being involved.
Recruitment & follow-up visits by practice team: network facilitates study set up, provides guidance documents and support
Network nurse support where there are workload pressures in the practice team eg EDS study, past bp
Secondary care studies that need to find patients in primary care: network finds sites locally and supports practices undertaking site feasibility, and referring patients to research clinics in hospital recruitment
Outreach work from universities – direct university research team support for recruitment: network links the practice with the research team who will support activity in your practice eg FAST study
15. Funding for practices and clinical teams involved in portfolio research
The LES for Research - funded by E&H CLRN - Carol and Jacki have described this scheme
Study specific funding: consistent funding packages to reimburse practice for work involved.
16. Your questions answered: The scientific content
Interest & relevance
The support available
training & facilitation
Fit with practice
who will lead this?
randomisation & impact on care
Conflicting priorities in practice
17. Benefits for research-active organisations Patients in trials have better outcomes than those who do not enter studies.
Patients can access new treatments early.
Many patients want to contribute to the development of better care for all.
Professionals can benefit from training and development opportunities.
Research brings additional funds to clinical services.
Research involvement is seen as a proxy indicator of high standards and can help recruit and retain staff.
18. New participants recruited 08-09
This is what we offer
but we need your help.
We are looking for more practices and clinical teams who would like to get involved at a level that’s right for them.
20. Secondment to PCRN-EoE - opportunity for Allied Health Professional
One day per week for one year.
Become a member of PCRN-EoE team
Promoting research in your organisation
Introducing a portfolio study into your team
Opportunity for training
Possibility of further funding
21. Treatment alternatives for Acute Sore Throat in Everyday practice
460 participants needed – 3-5 per practice
Present with acute sore throat
Age over 16 years
Must be able to self medicate with gum or probiotics
Minimal exclusion criteria
Set up, database search, mail shot
Opportunistic recruitment, pack handouts
GP/Practice nurse time, admin time funded
Training for intervention/informed consent required
22. EDS: 5659 EDS trial – erectile dysfunction and simvastatin: a randomised controlled trial
Men, age over 40 with previously untreated ED
demonstrate if Simvastatin improves ED
If improvement correlates with reduced cholesterol and/or improved endothelial function
cost effective ED treatment which could prevent future CVD
Randomised, placebo controlled, double blind, parallel group
10 sites - at each site:1,188 contacted, 43 screened,
24 run in, 17 randomised
24. Past bp: A randomised controlled trial of different blood pressure targets for people with a history of stroke or transient ischaemic attack (TIA) in primary care: 5987 Can more intensive BP targets for people who have had a stroke or transient ischaemic attack be achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on quality of life.
Identify and invite patients from practice database.
One GP and one nurse to attend half day training] on study procedures and NICE guidelines for measurement and treatment of hypertension
Provide a room for PCRN nurse to see patients for clinics
GP to see patient and determine whether alteration is needed to anti-hypertensive medication using the study specific treatment protocol
Practice nurse to carry out patient follow-up at 1-3 monthly intervals depending on BP and treatment allocation.
25. TOMAS: A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: 6696
The health care objective is to improve the quality of people’s lives after a stroke by enabling them to get out of the house more often
The research objective is to test the effectiveness and cost effectiveness of treating people with a stroke with mobility intervention.
A novel rehabilitation technique (intervention) group will be compared to a usual care (control) group.
Intervention group participants will receive up to 12 rehabilitation outdoor mobility sessions of about an hour each over up to 4 months. Control Group participants will receive what is considered clinically to be routine intervention for outdoor mobility limitations.
26. VENUS IV: Venous leg Ulcer Study IV: A randomised controlled trial of compression hosiery versus compression bandaging in the treatment of venous leg ulcers: 7994
To assess the clinical and cost effectiveness of compression hosiery compared with 4 – layer compression bandaging in terms of ulcer healing; quality of life and patient concordance.
27. RAPSID: randomized controlled trial of the efficacy of peer support delivered through a buddy (1:1) approach, a group approach or combined 1:1 and group approach. 8010.
recruit 1550 patients with Type 2 diabetes
via through general practice and through the community
Local areas (clusters) will be randomised to have either:
Individual 1:1 support, Group support, Combined 1:1 & group support or no peer support (control)
All participants will receive an educational package
Participants who are selected and are willing to act as Peer Supporter will be given training by the research team.
GPs to provide a reference for potential peer supporter facilitators
Baseline visit to be undertaken by PCRN/ network nurses including consent
Practice Nurses /HCA/Phlebotomist to obtain blood samples at 6/12 visit
Outcome measures are metabolic control, quality of life and self-care practice
29. EUDRAGENE: 4412
Objective - establish a collection of DNA samples as a resource for studying genes which influence serious or adverse drug reactions (ADRs)
5 approx recruited per practice
£295/practice plus £43/patient recruited
10,000 plus size practices
Data base search and manual note review
blood test, consent & questionnaire
Patients can consent through post or attend surgery for appointment with blood test
30. Why is the UK a terrible place to do clinical research? Workload increasingly tightly defined:
Too busy to be involved
“amateur” research no longer viable
Expensive compared to other countries
MRECs, LRECs, RM&G etc
Restrictions on access to data
Honorary contracts +++
31. PCRN-EoE STRUCTURE (2009) NOTE: STRUCTURE DOES NOT DESCRIBE THE LINE MANAGEMENT & ACCOUNTABILITY ARRANGEMENTS.
32. Studies in 2008
33. Types of research
34. Why is the UK a great place to do clinical research? Comprehensive healthcare for population
Excellent clinical facilities
Outstanding science base
Commitment to evidence-based medicine
We need evidence that’s relevant for everyday practice
Many patients are positive about research