DECISIONS is Development of a Comprehensive Intervention to Support Individuals with anticoagulation to prevent Stroke.
Stroke is now the fourth most common cause of death in the UK and the main cause of severe disability, with an estimated annual cost to the NHS of £3 billion for emergency, acute, rehabilitation, and long-term care. Conditions which put people at an increased risk of developing a blood clot, and consequently experiencing a stroke, can be successfully managed using oral anticoagulation (OAC) medicines, also known as ‘blood thinners’.
However, evidence suggests that many people who would benefit from these medications either do not receive them or do not take them in a way that would confer maximum protection. This is further complicated by the fact that for some of these conditions there are no obvious symptoms and so the underlying risk goes undetected.
For example, in England there estimated to be over 1.3 million people with atrial fibrillation (AF), of whom about 5% will go on to have a stroke each year. While one fifth of people admitted to hospital with stroke in the UK have AF, many of these people are first diagnosed with the condition only when they present with their stroke or other vascular disease.
Other conditions which also confer an increased risk of blood clots and stroke include diseases of the heart valves or structure, mechanical heart valve replacement, and a history of stroke or peripheral arterial disease. To reduce the overall risk of stroke death and disability in people with these conditions, it is imperative that they are effectively treated with OAC medication.
For many years, OAC treatment has been dominated by a single drug, warfarin. In AF, warfarin reduces the annual risk of stroke or death from 5% to 1.7%. However, characteristics of this medication (e.g. variability of dose and response, narrow therapeutic range, numerous interactions with other drugs and foodstuffs) means that regular monitoring in the form of blood tests is required.
Poor control however remains common resulting in higher bleeding risks and poorer prevention of stroke than can be achieved when control is optimal. In more recent years, new drugs have come onto the market which involve less complex treatment protocols.
In contrast to warfarin, these direct oral anticoagulants (DOACs) do not require dose adjustments and therefore do not require the same frequency of blood tests. However, despite the simpler dosing regimens of DOACs, they are not without challenges. In particular, DOACs have shorter half-lives which means that poor adherence results in gaps in an individual’s protection from stroke. This is especially concerning in light of recent research which has highlighted a lower adherence to DOACs compared to warfarin.
Aims and objectives
The DECISIONS study will use co-design principles to develop a novel care pathway and a resource guide to improve uptake, shared decision making, and long-term adherence/persistence to medication in anticoagulant therapy for stroke and arterial thromboembolism prevention in AF and other conditions.
The study will take place in up to 6 GP surgeries within three Clinical Commissioning Groups (CCGs) in the North West of England and will consist of three phases designed to achieve three core objectives:
To map current service design and delivery of oral anticoagulation care for stroke and arterial thromboembolism prevention in primary care in order to critically review current models of care and their effectiveness.
To identify barriers and facilitators to the effective implementation of models of care delivery and the effective management of oral anticoagulation in stroke and arterial thromboembolism prevention that are experienced by multi-professional clinical staff and by patients and relatives/carers.
With patients, relatives/carers, and health care professionals, to co-design a care pathway and associated resource guide to support the initiation and ongoing management of oral anticoagulation in stroke and arterial thromboembolism prevention in primary care.
The aim of Phase 1 of the study is to collate data about current practice relating to oral anticoagulation (OAC) for stroke prevention. Firstly, we will conduct stakeholder group discussions to collect information about the intended model of service provision at each participating site. These group discussions will include all staff groups (healthcare professional, managerial and administrative), people with AF and those taking OACs for other relevant conditions, and relatives/carers. To develop a picture of intended service provision we will collect information on: the staff involved in OAC management; how, when, and where services are delivered; the roles of multi-professional and multi-specialty team members; resources available (e.g. use of GRASP-AF); training received; provision of support for people taking or considering OAC therapy; transfer of information and care between primary and secondary settings; how and to what extent primary and secondary care provision is integrated; communication with, and support from, local community pharmacies. During this phase of the study we will also collect information on actual management of OAC by extracting anonymised information from the medical records of patients who have known indicators for long-term OAC therapy.
The aim of Phase 2 of the study is conduct in-depth qualitative interviews with healthcare professionals, patients, and their relatives to more fully understand experiences of OAC management, along with their perspectives on the strengths, limitations, barriers and facilitators to effective management of oral anticoagulation. We will interview up to 24 healthcare professionals, 20 people with AF and other conditions, and 10 relatives/carers across the six participating sites. We will endeavour to recruit people with a range of experiences of OAC management including those who have recently commenced taking OACs; who have been taking them for a longer period (>1 year); who have never been prescribed, have declined or discontinued OACs; who have experience of taking VKAs, or DOACs, both, or neither; patients with a range of clinical conditions including if possible non-valvular AF, valvular AF, mechanical heart valve replacement, other structural cardiac disease, and peripheral arterial disease; patients with diverse characteristics with respect to gender, age, ethnicity, previous stroke or arterial thromboembolism diagnosis, and residence (living alone or with a family member).
In Phase 3 of the study, the stakeholder group will use the information from Phases 1 and 2 to co-design an evidence-based care pathway and associated resource guide to support the initiation and ongoing management of oral anticoagulation in stroke and arterial thromboembolism prevention in primary care. We will identify current aspects of good practice, identify areas for improvement, select strategies and measures to change practice, and share between stakeholder groups via an iterative process. The focus of the care pathway will be on supporting, where possible and desired, shared decision-making and patient self-management in relation to anticoagulation. The package is likely to focus on the initiation, optimisation and continuation of treatment in primary care, but will include some elements relating to transfer of care between primary and secondary settings. All elements of the care pathway will be co-designed and are likely to include interventions at organisational level (e.g. overall pathway and procedures), staff level (e.g. training, educational resources, behaviour change interventions), and individual patient/carer level (e.g. behaviour change interventions, support to access and use self-management resources). Next steps in the DECISIONS study will involve funding applications to test the feasibility, acceptability, and effectiveness of the developed care pathway and resource guide.
Expertise and Subject area
Dr Josephine Gibson
Clients or Funders
National Institute for Health Research, RfPB Competition 34 Stage 2, PB-PG-0817-20043, £141,084.00
May 2019 – April 2021
Collaborators and Partners
University of Central Lancashire
- Professor Dame Caroline Watkins,
- Rachel Georgiou
- Professor Umesh Chauhan
- Professor Paul Rutter
- Dr Amitava Banerjee
- Dr Miland Johsi
Wirral University Teaching Hospital NHS Foundation Trust
- Dr Deborah Lowe
University of Liverpool
- Dr Deirdre Lane
Royal Liverpool University Hospital
- Professor Cheng Hock Toh