A multi-agency Atrial Fibrillation (AF) Community of Interest has been established across UCLPartners. It has identified four priority work programmes to improve access for people with AF to evidence-based interventions along the care pathway. The work programmes currently underway seek to address barriers to uptake particularly of anticoagulation in line with NICE guidance.
We are also collaborating with the 3-year prospective observational ORANGE study collecting data on the management and clinical outcome of patients who develop major bleeding whilst on oral anticoagulants across the UK to develop better bleeding management strategies for the future.
Additional authors: Dr Peter MacCallum & Dr Laura Green (ORANGE study) Contact email: BHNT.Orangestudy@nhs.net Tel: 020 7882 6203
This example was originally submitted to demonstrate implementation of NICE CG180. This guidance has been updated and replaced by NG196. This example continues to align with recommendations in the updated guidance. The new guideline NG196 should be referred to if replicating any aspect of this example.
Aims and objectives
The primary objective of the work is to enable people with AF to access the most innovative, evidence-based interventions to improve and save lives.
To address this primary objective, four work programmes have been established with the following aims:
- To improve information and support to people with AF
- To address knowledge gaps around optimising adherence to anticoagulation
- To improve identification and management of AF in primary care
- To address knowledge gaps around bleeding associated with anticoagulation
The most detrimental complication of all OAC is the development of major bleeding, particularly intracranial haemorrhage, leading to significant mortality and morbidity. Whilst there is an antidote for warfarin, none exists for three of the NICE-approved OACs. The primary objective of the ORANGE study is to ascertain the proportion of patients who develop major bleeding while on oral anticoagulants (OAC) and who: (a) present with intracranial bleeding (ICH); and/or (b) die within 30 days of the event. This will pave the way for the establishment of a national reporting system for oral anticoagulant agent associated bleeding events. In addition the effectiveness of products such as prothrombin complex concentrate (PCC) will be assessed - in terms of clinical outcome - in treating major bleeding associated with OAC; the coagulation abnormalities at presentation of major bleeding will be characterised and any associations between clinical outcomes and the management of major bleeding will be assessed.
Reasons for implementing your project
Prevalence of known atrial fibrillation across the six million population within UCLPartners' geography is 1.07% (61,764 persons QOF 2012/13). If prevalence was increased to the national average (1.52% QOF 2012/13) we would identify a further 25,698 people with AF. Furthermore, work within one Clinical Commissioning Group revealed that only 57% of patients known to have AF and eligible for treatment are taking anti-coagulation, compared to 65% in England.
Increasing evidence-based care for people with AF could prevent approximately 700 strokes annually across UCLPartners, avoid the associated distress and disabilities, save 210 lives and save millions of pounds, with AF strokes costing £11,900 in the first year in NHS costs alone (Hunter et al 2013). The AF care pathway was mapped through conversations with the AF Association (AFA) and local clinicians. The pathway was framed, with help from the AFA, from the perspective of how each phase might feel to people with AF. For example, 'Am I alone?' and 'Where am I going?' representing 'initiation of treatment'. It also included a range of evidence-based interventions and examples of good practice. The pathway, represented on a single slide was used to stimulate discussions on where the AF community wanted to focus effort.
The Orange study began recruitment on 1 October 2013 and will continue until 31 December 2016, with a recruitment target of at least 2250 cases. There are currently 11 hospitals across the UK participating in the study and we are open to new sites. Unlike warfarin, whose anticoagulant effect can be wholly reversed by prothrombin complex concentrate (PCC), there is no antidote for the new OAC. Since there have been no studies to inform the management of bleeding associated with these new OAC, attempts to reverse their activity will understandably rely on existing strategies. It is anticipated that reversal for the new OAC will be at best partial and associated bleeding outcomes may therefore be worse than those associated with warfarin. It should also be recognised that the clinical outcome of major bleeds for NHS patients on warfarin are uncertain despite the existence of national guidelines that recommend interventions known to reverse the effects of warfarin on the coagulation system. Based on extrapolation of data from clinical trials and the estimated £1million UK patients on OACs, there are likely to be 20,000 major bleeds per year related to OACs use within the NHS.
How did you implement the project
A Community was formed through the mapping exercise and an event, which brought together providers, commissioners, charities, academia, the NICE Implementation Collaborative (NIC) and industry.
The community prioritised 4 work programmes, led by clinicians and/or academics and supported by the AFA and UCLPartners:
- Information and support: designing a platform to provide personalised information for people with AF to support access to innovative treatments and self-management.
- Adherence Academy: bringing healthcare professionals and academics together to build capability around personalised interventions; designing and testing new adherence interventions and generating responses to critical knowledge gaps.
- Primary care interventions : supporting primary care to better identify and treat AF.
- National Bleeding registry (ORANGE STUDY): to address knowledge gaps around bleeding associated with anticoagulation.
In-depth interviews: With the support of the AFA, the Innovation Unit was commissioned by UCLPartners to carry out in-depth interviews to gain insights into peoples' experience of the AF care pathway. A range of dimensions were explored: attitude to information, satisfaction, use of technology, networks and sense of control. These have informed the work programmes, particularly the design of the patient information platform.
Quality standards: Improvement Science London is supporting UCLPartners to co-develop a set of whole pathway quality standards and associated metrics. The aim is for CCGs to use these to track improvements in care and benchmark their performance. A number of CCGs have agreed to populate the draft 'scorecard' over the summer. The work to date has been resourced primarily through clinicians and academics giving their time to drive the shared aim of improving people's lives. UCLPartners provides a broad range of support including, a clinical lead for the AF programme, project management, convening the community, securing specialist support, securing additional resources, etc. The NIC kindly seconded a part time project manager (from BMS) for 6 months to help with the creation of the community. UCLPartners is currently working with two pharmaceutical companies to secure part time project management secondments. A Community Pharmacist Darzi Fellow, funded by Health Education North Central and East London, starts in September 2014 to set up a community pharmacy led adherence support scheme.
The work programmes, which were agreed in September 2013 are in various stages of delivery.
The Oral anticoagulant agent-associated bleeding events reporting system (ORANGE) study has been discussed here. The most advanced is the 'Primary Care Interventions Package'. Please refer to Improving anticoagulation in atrial fibrillation: Primary care interventions
The findings from the interviews from people with AF are available on request.
Key learning points
The three key learning points to date are:
- Start with what matters most to patients and to your local community. Working with the AF Association has been invaluable and helped to ensure the work is grounded in what matters most to patients. Convening a Community of Interest which set its own priorities from the bottom up ensures local ownership and also mobilises capacity to deliver improvements.
- Be creative about securing resources. Initially we spent considerable effort trying to secure external funding for each of the work programmes. However, we have made significant progress since September 2013 by focusing on the assets that already exist locally within our Community of Interest. Progress can be made by connecting people, building on existing work and finding ways to wrap support around people who want to lead improvements.
- The NICE-approved OACs have significant advantages over warfarin, however, they currently lack an antidote in the event of major bleeding and evaluation of the outcomes of major bleeding in routine clinical practice and of current management strategies are important
The ORANGE study is sponsored by Queen Mary University of London and funded by the British Society for Haematology.