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Nurses play key role in major primary care trial on aspirin use

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Research nurses have been credited with playing a key role in recruiting patients to take part in what is believed to be the largest drug trial of its kind ever to take place in the UK.

More than 30,000 patients were recruited over a five-year period to the study, which is looking at whether antibiotics can help reduce the risk of stomach bleeding in aspirin users.

“This is an important study for patients, clinicians and the NHS”

Ruth Gibbins

The Helicobacter Eradication Aspirin Trial – known as HEAT – has been funded by the National Institute of Health Research (NIHR), which used about 80 clinical research nurses to sign up patients.

As a result of their contribution, the HEAT trial is believed to be the largest interventional academic drug trial in the UK.

The study, which was devised by the University of Nottingham, Nottingham University Hospitals NHS Trust, University of Southampton, University of Durham and University of Oxford, was conducted at 1,260 general practices across England, Scotland, Wales and Northern Ireland.

“We didn’t incur any nursing recruitment costs, because we were able to use clinical research nurses available through the NIHR,” said Jen Dumbleton, clinical trials manager for the study.

“We also used a mixed model of recruitment, which gave us added flexibility,” she said. “For example, in some regions we used practice nurses and in others we used a combination of nurses and healthcare assistants.

“The nurses were able to consent up to 12 patients a day, which is why we were able to recruit in such large numbers,” noted Ms Dumbleton.

Aspirin is widely used to help thin the blood and reduce cardiovascular risk but, as is well known, even relatively low doses have been linked to increased risk of gastrointestinal bleeding.

“This would not have been possible without the support of clinical research nurses”

Phil Evans

The HEAT study hopes to establish whether a short course of antibiotics that remove H pylori bacteria from the stomach might reduce the risk of gastric bleeding in regular aspirin users.

If the trial is successful, researchers believe it could help boost patient safety, reduce hospital admissions and ultimately save the NHS money.

“This is an important study for patients, clinicians and the NHS, because a gastric bleed is a potentially life threatening condition and often results in a substantial stay in hospital,” said NIHR clinical research nurse Ruth Gibbins, who helped recruit patients for the study.

The study involved patients aged 60 and over who took 325mg of aspirin or more per day and had four or more 28-day prescriptions in the past year.

They underwent a 45-minute interview with a registered nurse who talked them through the research, obtained informed consent and tested for H pylori as well as taking body measurements.

Those patients who did have the bacteria went on to take a seven-day course of antibiotics or a placebo.

In total, 5,357 patients tested positive for H pylori, who will continue to be followed up, with the results of the trial due to be published in 2020.

National Institute of Health Research

Nurses play key role in major primary care trial on aspirin use

Ruth Gibbins, NIHR clinical research nurse

The health check carried out as part of the initial interview saw nurses measure blood pressure, body mass index, alcohol consumption and smoking status – data which was reported back to GP practices, saving those surgeries time and money.

Dr Phil Evans, NIHR national speciality lead for primary care, said the trial was a great example of how a large-scale research project could be carried out with nurses playing an integral role.

“The HEAT study is an excellent example of how you can scale up research within a primary care setting,” he said.

“This would not have been possible without the support of clinical research nurses, who have a vital role in recruiting patients to take part in research and, in doing so, are enabling access to improved care and treatment,” he added.

The NIHR carried out a joint survey with Nursing Times earlier this year on the role played by nurses in research and the barriers stopping them getting involved, ahead of a new strategy.

Workforce pressures, education structures and negative perceptions were all holding back nurse involvement in vital research and innovation that could benefit patient care, the survey revealed.

The HEAT study was funded through the NIHR Health Technology Assessment Programme, while the NIHR Clinical Research Network supported the study set-up and patient recruitment.

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