A new clinical research study which is expected to start recruiting in January 2021, will use a novel approach based entirely at GP surgeries.
The DaRe2THINK study is aimed at preventing stroke, premature death and cognitive decline in patients with atrial fibrillation (AF) and will use existing data from their GP records to identify suitable participants, reducing the need for additional appointments.
It has been awarded £2.7M funding by the National Institute for 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.
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.
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 - 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 3000 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.
Dr Shukla, who is also Primary Care Clinical Research Lead for the Clinical Research Network West Midlands said: ‘DaRe2THINK will create the potential for 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.’
Dr Janet Valentine, CPRD Director, said: ‘The Clinical Practice Research Datalink is delighted to collaborate with the University of Birmingham on this important and innovative trial.
‘In addition to helping us understand whether we can improve health outcomes for patients with atrial fibrillation, the trial is using novel data-enabled methods to recruit, manage and follow-up patients. We hope this new approach will lead to improvements in the efficiency of delivering clinical trials for wider patient benefit.’