Complex intervention comprising text MEssaging anD HEalthcare professionaL training for imProving statin adherence in primary care: a pragmatic cluster-randomised controlled trial (MED-HELP)
Why the research is needed?
Patients who either have or are at risk for cardiovascular disease are often prescribed statins. However, many patients struggle to take their statins regularly as prescribed (termed ‘medication non-adherence’) due to a variety of reasons. Furthermore, many patients may not be receiving the optimal statin dose as recommended by contemporary guidelines. This puts these patients at increased risk for cardiovascular events.
What is already known about the subject?
Medication non-adherence is a highly prevalent issue, particularly with statins. It can be a particular problem in people with multiple long-term conditions, as they often have to manage several medications at once, increasing the risk of non-adherence. The aim of the study is to improve statin adherence by providing patients with ongoing text message reminders and by delivering training to healthcare staff to help them to make an informed decision about intensification of statin prescribing. This will help to ensure that current statin treatment guidelines are being followed, and that patients are supported to increase or maintain their statin adherence.
Who we are working with?
We are working with local GPs and practice nurses to help us with the design and delivery of our intervention. We are also working with a software company (PRIMIS) to enable us to extract and analyse routine data from GP Practices in order for us to evaluate the effect of the intervention.
How are patients and the public involved?
We are involving people who take statins, by engaging them in the research process from the start, to ensure that our aims and outcomes match what they want and expect.
What we will do?
We will recruit 40 GP practices from locations across England to take part. Practices will be randomly allocated to one of two groups: either a usual care group (this involves the practice continuing with the normal routine care for the management of patients with or at risk of cardiovascular disease) or an enhanced care intervention group. In the intervention group, we will provide training to practice staff to help them optimise statin prescriptions for their at-risk patients, and discuss non-adherence with patients where required. We will also send regular reminder text messages to patients displaying signs of statin non-adherence, in order to support them to take their statins more regularly. We will compare the two groups, at the start of the study and at 15 months, to find out if the training and text messages make a difference to statin prescriptions and adherence.
What the benefits will be?
This research will potentially improve statin adherence and optimise statin prescription habits in participating practices. This will result in a reduction in cholesterol in at-risk patients, and as such reduce the risk for future cardiovascular events.
When the findings will be available?
We plan to have findings available by 2024.
How we are planning for implementation?
We are planning for implementation by developing a communications plan aimed at the widest possible audience, to promote awareness about the study.
Patrick Highton, firstname.lastname@example.org