Case study: DaRe2THINK - A novel approach

A new clinical research study which has recruited its first two patients in the West Midlands is using a novel approach based entirely at GP surgeries.

GP Dr Claire Jones of Spring Gardens Medical Practice talks about their involvement in the DaRe2THINK study which is aimed at preventing stroke, premature death and cognitive decline in patients with atrial fibrillation (AF). The study will use existing data from their GP records to identify suitable participants, reducing the need for additional appointments.

‘We are a very research active practice and had been involved in previous AF studies, so when Dr David Shukla, the Network’s Lead for Primary Care Research asked for volunteers, we were happy to step up. We were very keen to get involved as we see it as a hugely important study, with the potential to prevent strokes and vascular dementia.

‘We have worked with the Network before and this linked nicely with previous research. As we were already engaged with CPRD*, it seemed to follow naturally. Their pseudonymised process found that we had two patients who fitted the study criteria and both were very keen to participate as they had relatives with dementia.

We fully expect more patients to be flagged as they come into the age group. Participants will be randomised to the anticoagulant arm, or to receive usual care and they will be asked to complete six-monthly questionnaires as well as an annual cognitive challenge.

‘It has been really fun and interesting to be part of the pilot, which is very IT-based, including the consent process which cuts out clinic visits for participants. There has been a lot of work on things such as simplifying the login process, but we have been very well supported by the
Network staff, who have been very hands-on in helping to speed up the process. Frankly, they have been brilliant and we wouldn’t have been able to do it without them.

‘The patients are thrilled to be taking part and they are as excited as we are that we may be able to prevent vascular dementia by treating AF slightly earlier.’

About the Trial

It has been funded by the National Institute of Health Research Health Technology Assessment Programme which funds research about the clinical and cost-effectiveness and broader impact of healthcare treatments and tests for those who plan, provide or receive care from NHS and social care services.

Using the Clinical Practice Research Datalink’s (CPRD) novel data-enabled clinical trials services, DaRe2THINK will create the potential for randomised controlled trials (RCTs) that pre-screen from over 12 million NHS patients in primary care - a transformational and cost-effective approach that places the UK at the forefront of pragmatic clinical trials.

It can target recruitment to regions or even individual GP practices.

This trial also offers the potential for lifetime ‘no-visit’ follow-up by accessing all primary and secondary care data across England for consented participants, using integrated technology for e-consent and follow-up (e.g. patient reported outcomes).

The study will recruit 3,000 patients from around 600 GP centres across England.

GP Dr David Shukla is Co-Chief Investigator for the study with Dipak Kotecha, Professor of Cardiology at the University of Birmingham & University Hospitals Birmingham NHS Foundation Trust. Find out more about the trial by visiting the website.

About Atrial Fibrillation

Atrial fibrillation is a condition where the heart’s natural pacemaker fires off from different places in the heart, causing chaotic electrical activity, resulting in an irregular pulse. It is thought to affect as many as one million people in the UK, but there are probably many more who are undiagnosed or don’t know they have it.

Patients with AF have a higher risk of stroke and suffer from frequent hospital admissions and poor quality of life. They also have a much higher risk of cognitive decline and dementia due to silent ‘micro-strokes’ that gradually damage the brain over time.
Direct Oral Anticoagulants substantially reduce the risk of stroke in patients with AF but are usually only given to older patients or those with multiple risk factors. This may be too late to prevent dementia, and leaves those younger than 65 years, and some patients aged 65-75 years without treatment that could prevent these devastating complications. More information about AF and strokes on the British Heart Foundation website.

*About CPRD

Clinical Practice Research Datalink (CPRD) is a real-world research service supporting retrospective and prospective public health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care.

CPRD collects anonymised patient data from a network of GP practices across the UK. Primary care data are linked to a range of other health related data to provide a longitudinal, representative UK population health dataset. The data encompass over 60 million patient lives, including 16 million currently registered patients. For more than 30 years, research using CPRD data and services has informed clinical guidance and best practice, resulting in over 2,800 peer-reviewed publications investigating drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors.

The UK is in a unique global position to use clinical records in novel ways for patient recruitment, clinical trials management and follow up. In addition to supporting high quality observational research, CPRD is developing world leading services based on using real world data to support clinical trials and intervention studies.