The aim of this study is to find out whether the Bristol Medication Review (BRISMED) toolkit can improve standards of medicines use compared with usual general practice care.

What is the problem?

Medicines are an essential intervention used by health services to treat and prevent disease, and improve wellbeing. Used appropriately, medicines can significantly improve important health outcomes. But there are also risks of harms, due to hazardous prescribing or side-effects.

Medicines optimisation aims to ensure safe and effective medicines use. Medication review is a critical part of this process. However, current clinical guidelines and approaches to carrying out reviews are not underpinned by robust scientific evidence. Current practice lacks standardisation, is not patient centred or clinically effective, and clinicians lack appropriate training.

New evidence is needed to inform the delivery of effective medication reviews, underpinned by availability of appropriate tools to allow implementation in clinical practice.

What is the BRISMED toolkit?

The BRISMED toolkit includes a number of resources which aim to help clinicians carry out reviews in general practice. It includes an evidence-based model of how to deliver a comprehensive, patient-centred, structured medication review, as well as guidance, training and resources for practices to support implementation.

What we aim to do

The project has three core objectives:

1. Successful implementation of the BRISMED toolkit in general practices.
2. Comparison of clinical effectiveness of the BRISMED toolkit with usual care, alongside an evaluation of the cost implications.
3. Assessment of acceptability to, and experience of, patients and practitioners.

Study design

This is a large, highly pragmatic, cluster randomised controlled trial. It will be conducted in around 1,000 general practices in England contributing data to the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), based in Oxford (ORCHID team). The trial will compare the BRISMED toolkit to usual clinical care.

• The BRISMED toolkit will be provided electronically to 500 randomly chosen practices, with practices able to implement any or all of the resources as they see fit.
• Medication reviews are recommended for any patient receiving long-term medication, so there are no constraints on which patients need to be reviewed. We plan to study use of the BRISMED toolkit over a 12-month period, starting in April 2024.
• The primary outcome of the trial is the rate of potentially inappropriate prescribing. Several secondary outcomes are being measured, including medication outcomes (drug count, regimen complexity, adherence, adverse reactions) and health service usage. Outcomes will be determined using routine electronic health record data obtained through the RSC network.
• A cost-consequence analysis will also be undertaken, to understand the health economic impact of using the toolkit.
• In addition, a mixed-method process evaluation will be conducted to understand users’ experience of the reviews that are being carried out, to explain the success or otherwise of the intervention, and to explore its acceptability to users.
• Implementation and adoption of the Bristol toolkit will be evaluated by conducting surveys in all practices, and extracting relevant data from electronic health records.
• Patient surveys will also be undertaken in a subset of 56 practices to evaluate patient experience and quality of life. Interviews will be undertaken to further assess patient and clinician views, and observations of reviews used to assess intervention fidelity.

What GP practices need to know

Information for GP practices in the intervention arm

Practices that are randomised to the intervention arm of the trial will be provided with access to a website with a range of easy-to-use resources that clinicians can use when carrying out medication reviews. This will include:

• details about the Bristol Medication Review model and guidance on how to use it
• advice for practices on how to implement more effective reviews
• self-directed online training materials (including access to CPD certificates)
• a “primer” document that patients can use to prepare for their review, and
• templates for clinical informatics systems to help record information about the review.

Practices and clinicians will be able to use these resources as much or as little as they want. There is no need for practices to record anything for the purposes of the trial – just whatever needs documented for normal clinical care.

• All the data required is extracted remotely, as part of a practice’s ongoing contributions to the RSC.
• Practices will be reimbursed £440 for clinicians’ time spent doing the training.
• We will send each practice a short survey at the end of the study to try and understand experiences of using the toolkit.

Information for GP practices taking part in the process evaluation

We are also asking 56 of the 1,000 participating practices to additionally participate in the process evaluation. This will provide us with a more in-depth understanding of practitioner and patient experience of medication reviews, identify possible mechanisms and contextual factors behind treatment outcomes in both trial arms, and explore acceptability, implementation and scalability of the BRISMED toolkit.

• An administrator at each of the 56 practices will need to run six searches in SystmOne or EMIS over a 15-month period, to identify patients who have had a recent medication review.
• A brief survey will then be sent out to these patients to explore their experiences of the review, as well as factors such as health conditions and quality of life. The invitation for the survey will mainly be sent using text messaging, so practices will need to have the relevant AccuRx software to participate.
• In a smaller number of practices (15) , clinicians will also be asked to audio-record reviews over a two-week period, to help us understand how reviews are being carried out in practice.
• Finally, we will invite clinicians and patients to participate in some in-depth interviews of their experiences. Costs will be reimbursed for administrator and clinician time, as well as other relevant costs (e.g. text-messaging).

My practice is interested in taking part …

Great! We’d love you to help with this important work. You will need to be part of the RSC network of practices – if you are not, you can find out how to sign-up from the ORCHID team.

If you need more information, please contact the lead investigators, Dr Deborah McCahon at the Centre for Academic Primary Care, University of Bristol or Professor Rupert Payne at the Exeter Collaboration for Academic Primary Care at the University of Exeter.

Funder

The study is funded by the National Institute for Health and Care Research (NIHR) (ref. 154205).