David Wheeler and Lynis Lewis

Successful Renal Clinical Research Conducted in Primary Care

Date: 14 June 2018

We interviewed NIHR CRN North Thames Clinical Research Leads Dr David Wheeler and Lynis Lewis to understand how they worked together to get a secondary care clinical study successfully implemented in Primary Care.

Two key elements for success were very clear - the first was a dedicated primary care resource whose job was to liaise with practices and find patients suitable to offer the study; the second was the simplicity of the study - the fact it was a survey was a low barrier of entry for patients to participate and practices to make time for.

The third element for success is less defined, but essential and that is the power and work of CRN North Thames - it was an RDM who set up initial meetings between the leads, the network also provides a function for these leads work together.

In this sense - with a dedicated resource, a simple study and the network working together, getting research into primary care should be infinitely replicable.

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"Sometimes when you hit a brick wall you need to just stop bashing your head against it".

Immediately, Lynis Lewis comes across as having a very pragmatic 'get it done' attitude. I'm here because conducting research with patients of General Practioner (GP) surgeries is notoriously difficult, and a recent North Thames project that joined up Kidney (Renal) and Primary Care (PC) specialties has 'cracked the code' for accessing PC patients and inviting them into clinical studies.

The week prior I had interviewed Dr David Wheeler who had snuck off from his midday rounds in order that I could ask him questions and find out more about what his study did to get into the GP research space. Although not being interviewed in the same room, it's immediately clear that Lynis and Dr Wheeler have some things in common; and that’s a passion for getting patients access to the best possible care, and a determination to keep trying new ways of getting this done.

Lynis Lewis who’s primary role is Service Director, Research and Development at NOCLOR, is also the Joint Clinical Lead for Primary Care for CRN North Thames. Her NIHR North Thames counterpart for Renal Studies, Dr David Wheeler, looks after patients who have chronic kidney disease (CKD). He explains that “many have fairly mild kidney disease managed by GPs and they don’t see, or need to see specialists. (However), there are new drugs coming along that we would like to use in early chronic kidney disease as we think they slow progression and think getting it early will slow progression”. The problem Dr Wheeler had, as many specialty clinical studies experience, is that the early onset of this disease does not bring these patients into secondary clinical care at a time where new drugs going to trial might be able to help. Patients often are however, in the care of General Practitioners.

The solution, in hindsight, is ingeniously simple and infinitely replicable. Dr Wheeler took an existing survey, The National CKD Audit in Primary Care, and got it in front of new patients via GP surgeries. “What we said is ‘heres a questionnaire’ study for those patients with early chronic kidney disease, can we go into the practices find the patients and offer them this simple study first of all.” Dr Wheeler said.

The process required an NIHR funded Research Coordinator in Lynis’ team, to start liaising with research active general practices to identify patients who might have early onset CKD. They check with the relevant GP that we could approach the patient, and then, via the GP office, offer the patient a place initially in this observational study. Once these patients are in one study they are much easier to reach, contact and screen, with the longer term ambition of putting the patient in a future drug trial.

The idea of a survey study offers at least one major reason for the success of this project, and that is, for both GP practices and patients who have not been exposed to clinical research before, a survey acts as a simple, low barrier of entry, to a world that can often seem complex and scary to a patient, and time consuming to a practice.

The idea of using a questionnaire-style study potentially allays another perceived tension when it comes to conducting studies in primary care, and that is around where the recruitment figures accrue. In this study, a Renal study, the renal specialty received the benefit of increased recruitment numbers - although the study was conducted by Primary Care resource in a Primary Care setting. This particular survey study already existed to help identify patients with early symptoms of CKD, along the same lines, if it is already known that a study for a disease that has well-known early detection signs (such as some respiratory and cardiovascular disease have), is on the horizon, then primary care is a perfect place to conduct an initial study, receive recruitment numbers and pass on eligible patients to secondary specialty care studies who will then recruit to their specialist studies.

Lewis is quick to say, “it doesn't really matter if the accruals go to secondary care or us (primary care) because we all benefit, (for example) if UCLH recruit more because we’ve contributed to that , that's fine, it all adds to the pot, there just needs to be some recognition that primary care has helped. I think we all get stuck on the numbers game, that's the metric but really, the bottom line is we want to get our patients access to good quality studies. Does it matter if it happens in Primary Care or Secondary Care? No.” She does caveat that with “if we CAN conduct these studies in primary care lets do it in primary care, because it's easier for the patient. If it's more appropriate for us to be a site then lets be a site because our GPs and PIs can deliver”

Lynis says that a simple survey is always a good way to start out in practices, however, we do have practices that can do much more complex research. She says, “we have practices that are very research active, very research savvy. For a testbed or a new practice, a simple survey is a great start, but actually we have practices who can, and want, to do more complicated stuff - so there is no need to limit research in GPs to just surveys.”

She does warn that picking the right Practice is key. That on paper it sometimes seems as though a study should work within a practice, but often a complicated mix of team dynamics, practice workload and available resource will hinder success. Working in her role at NIHR North Thames she says “it's an attitude, lets just make it happen. Nothing is ever that difficult.” Her Primary Care admin team “can help pick the right Practice, for the right study, knowing the staff and the specialities at each practice.” She emphasises it is possible to get studies done ‘pronto’ if they can help select the locations for research, “we are very very supportive. We have a very supportive admin team here that will provide incredible support to the researchers. Whatever they want, whatever we can do for you”

Speaking to Ms Lewis and Dr Wheeler highlights the protagonists in this success story, but there is an invisible thread running through the achievement of this process and that is the power of the CRN North Thames Network who enabled this process to happen. It enables cross-specialty leads to have close working relationships and provides teams to, literally, help them network. Renal Specialty Research Delivery Manager Tania Page says of the network, “It understands opportunities and challenges and unblocks them and that is what our job is to do”.

The message is very clear. All our people are passionate about research being a way for patients to access the best possible care for patients. Primary Care research is ‘Open for Business’ in CRN North Thames.

  • Summary:
    We interviewed NIHR CRN North Thames Clinical Research Leads Dr David Wheeler and Lynis Lewis to understand how they worked together to get a secondary care clinical study successfully implemented in Primary Care.
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    • Renal Disorders
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