Barnet Federation

Research Network

1.0 Participating in Research

1.1 Working with Noclor

The North Central London Research Consortium (Noclor) is aresearch support service for those involved in mental health and primary care.It provides support to the Trustslisted,Central and North West London Foundation Trust, Camden & Islington Foundation Trust, East London Foundation Trust, Tavistock and Portman Foundation Trust, Barnet, Enfield & Haringey Mental Health Trust, West London Mental Health Trust and the Whittington.

Noclor works closely with the National Institute for Health Research (NIHR) Clinical Research Network: North Thames and manages support and infrastructure costs to support the delivery of research on behalf of the CRN. They help to facilitate recruitment to studies in Primary Care including dental practices and pharmacy across the geographical areas covered by the CCGs listed below.

Camden CCG
Islington CCG
Barnet CCG
Enfield CCG
Haringey CCG
Newham CCG
Redbridge CCG
Barking & Dagenham CCG
Tower Hamlets CCG
Havering CCG
Waltham Forest CCG
City and Hackney CCG
Hillingdon CCG

Noclor’s aim is to promote and support high quality research in primary care, community health and mental health in Barnet and North London. They put researchers in touch with a Research co-ordinator based within the federation (whom they are funding) whose role it is to assess interest for the research, search and recruit patients that might be suitable and facilitate site visits by Noclor nurses who are undertaking the research. Patients benefit from participation in research in various ways, such as intensive therapy (for Parkinson’s study); being provided with a revolutionary blood glucose monitor (for diabetes study) or intensive monitoring of patients with high cholesterol.

1.2 How does it work?

When Noclor have a study they are looking to recruit patients for there are a number of steps that need to be followed.

1)Noclor email the research co-ordinator with details of the study. This will normally include the title of the study, the objectives and the eligibility criteria of patients for the study.

2)The research co-ordinator and research lead will decide whether this study would be suitable for the surgeries within their network. If so, they email out this information to the GP lead for each surgery asking whether the surgeries are interested in participating in the research.

3)If a surgery expresses interest the research co-ordinator will need to fill out a form with information about the surgery and how many patients might be suitable to participate in the study. This necessitates a search on EMIS of patients who meet the search criteria, and might need to be done under the supervision of a nurse or GP with specific medical knowledge. This stage is known as an expression of interest and doesn’t form any kind of agreement. At this stage it is worth clarifying how much of the practice nurse’s time might be needed on the study. Noclor can provide nurses who can assess the patients etc, however nurses from the practice may be needed to take bloods etc and you need to ensure that you can spare the nurses without affecting their work.

4)Once there has been an expression of interest, the researchers running the study will be in contact to organise a site visit. The lead GP and a nurse or health visitor from the practice would need to be available as well as whoever is searching for the patients (normally the research co-ordinator). As well as this the Noclor nurse will come if she is helping with the study. This is the meeting where forms will need to be signed. If however the practice decides after further discussions that the study is not suitable for them then they are not obliged to go ahead with participation.

5)Following the site visit the researchers will ask for recruitment to begin. They will provide the practice with letters to send to patients outlining the study and why they have been asked to participate. The letter will also outline that they should not feel obliged to participate in the study if they don’t want to.

6)Meanwhile the research co-ordinator will undertake the search for patients according to the eligibility criteria. The researcher then needs to send the list of patients to the GP lead in each practice to check that they are happy for letters to be sent to them. The GP may choose to take selected patients off the list because they think they aren’t suitable for any reason.

7)Once letters are sent out, patients will be asked to contact the researchers directly so the research co-ordinator will need to ensure that the researchers let them know which patients are participating so that it can be noted on their records. In addition, patients who participate in research cannot participate in any further research.

8)Nurses from the practice may be asked to provide assessment and take bloods etc from patients. However this work may be undertaken by research nurses provided by Noclor. Who is doing what will need to be clarified before the research begins.

1.3 How long will the research take?

From the point of expressing interest to recruiting patients is generallytwo or three months but can be longer. However the length the study might take should be laid out in the initial forms sent out to gauge interest. In a recent study information sheet it states that there are 3 assessments at baseline, 6 and 12 month follow up therefore this study will take place over a year. However all the studies will differ according to individualrequirements.

1.4 What if a patient changes their mind part way through the study?

Patients are at liberty to change their minds about participation at any time during the study. This won’t affect them or their relationship with their GP in any way and is made clear when they are asked to sign a document confirming their agreement to participate in the study.

How are studies chosen?

Noclor chooses which study requests to take up using a number of criteria. These are also criteria that the practice has to take into consideration when deciding whether this study is suitable for them.

  • Is the research on a topic or a patient group that would interest GPs?
  • Is the study information clear about what is involved?
  • Does the study have the necessary permission (ethics and research governance) to proceed?
  • Is the researcher a trustworthy source (university team, NIHR Research network; NHS Trust Academic or professional body)?
  • What markers of quality does this research have? (funding body, PhD study, on NIHR portal)?
  • What benefits will our patients and our practice derive from participation? This could include extra monitoring and equipment, early access to new treatments, information for QOF and early access to cutting edge results
  • What are we (the practice) expected to do for this study and do we have the staff to carry it out? The research co-ordinator should be able to carry out all the patient searches and mail outs, however nurse time may need to be put aside – although nurses are often paid by the research team for their time on the study.
  • Will we be reimbursed sufficiently for what we have to do? Will our costs and staff time be adequately covered? Will we be out of pocket?
  • Will the reimbursement give us any profit? Is there addition reimbursement over and above our costs?
  • Will we receive any resources other than financial? Will we get to keep any equipment used for the study? Will we receive helpful resources eg guidance charts or documents or access to expertise?

1.5 Do all studies require the same levels of participation?

Noclor classifies studies according to what level of involvement is required.

Level 0 – may include a quick database search to ascertain whether certain types of patients can easily be identified for a study seeking to recruit in primary care.

Level 1 – NIHR Portfolio study needing minimal practice support, such as a database search for patients fitting specific criteria before a letter is mailed out inviting patients for participation in a study.

Level 2 –NIHR Portfolio study which is similar to level 1 PLUS some practice involvement from a member of staff such as conducting initial suitability screening and consent of patients.

Level 3 – NHIR Portfolio study which involves level 1 PLUS where members of staff are trained to deliver a specific intervention, then undertake baseline screening, patient consent, delivery of a study intervention and delivery of baseline and follow up date. For example a study on weight management where a nurse is trained to deliver an intervention, then screens, consents, takes baseline measures of height, weight, blood pressure etc, gives brief intervention and sees patients for follow up and repeats weights and blood pressure measures.

Level 4 – NIHR Portfolio study similar to level 3, with is a controlled trail of an investigational medicinal product (CTIMP) - often a commercial study. The intervention involves a member of the practices clinical team dispensing and administering a medicinal product, undertaking and recording baseline and follow up data collection on behalf of the study team, eg of bloods, urine, blood pressure and questionnaire / participant feedback.

1.6 Administration:

The research co-ordinator provides organisation and support of research projects and activities for all practices within the network. By having one individual to liaise with researchers and health care professionals, as well as recruiting patients and maintaining databases, allows GP practices who otherwise wouldn’t have the admin support to engage in research that can be of great benefit to their patients.

1.7 Benefits to patients and the practice:

Patients and the practice can benefit in a number of ways. Focussing on research in a primary care environment means that patients can benefit from for example intensive levels of therapy (eg for Parkinson’s patients in a study); use of blood glucose monitors not yet available on the NHS (for patients involved in a study for diabetes); or intensive monitoring for patients with high cholesterol. The surgery benefits as some studies require practice nurses or HCA’s to be sent for specific training which may enhance their skills. In addition, surgeries are often offered remuneration when participating in studies.

Participating in Research doc. 2016