Title: Implementing supported asthma self-management in routine clinical care: designing, refining, piloting and evaluating clinical and cost-effectiveness of a whole systems implementation strategy (IMP2ART)
Funder: Department of Health and Social Care

Abstract: Aims To develop a whole systems implementation strategy for embedding supported self-management in primary care, then testing the strategy in a UK-wide pragmatic, cluster randomised trial with clinical, implementation and cost outcomes determined from routinely collected data. Objectives To refine trial outcomes and sample size To define/refine a whole systems implementation strategy To pre-pilot feasibility/acceptability of the implementation strategy To pilot the trial processes To test in a national cluster RCT the impact on unscheduled asthma consultation, reported ownership of action plans; asthma control and cost-effectiveness To study the processes to inform roll-out and sustainability Background and rationale Asthma is responsible for substantial morbidity/mortality. Our recent meta-review (N=27 systematic reviews, n=270 RCTs) concluded that supported self-management for asthma reduces unscheduled healthcare, and improves control and quality of life for people with asthma at no additional cost to the health service. Implementation, however, remains poor in routine clinical practice; only 24% of people with asthma in the UK report having an action plan. Our review showed that effective implementation is multifaceted and multidisciplinary; engaging patients, training and motivating professionals within the context of an organisation that actively supports self-management. Research plan PG1: Refine trial outcomes We will refine algorithms for assessing outcomes in routine primary care data, and develop morbidity/health economic data collection questionnaires. PG2: Develop components of the implementation strategy and programme theory In a two-stage process we will refine individual components addressing a) patient-facing strategies/resources, b) professional-related strategies/education, and c) organisational strategies/routines: Mapping/theoretical development of components (pre-programme: funding AUKCAR). Feasibility testing refining components in &le;6 practices with different computer systems. Specific tasks include preparing the education module, developing audit/feedback reports. PG3: Pre-pilot feasibility of the whole systems implementation strategy Integrate individual components into a whole systems implementation strategy; develop/model programme theory. We will pre-pilot the implementation strategy in four practices, assessing acceptability/feasibility in qualitative interviews with key stakeholders. PG4: Pilot trial We will recruit 12 pilot practices in Kent/Sussex. Unless we identify problems necessitating substantial changes with intervention/trial procedures this will be an internal pilot. PG5: National pragmatic cluster RCT with health economic analysis Practices: 144 practices from Kent, Surrey and Sussex, North London, Lothian, Yorkshire. Patients: People aged &ge;5yrs with a coded asthma diagnosis and prescribed asthma treatment in the previous 12-months, excluding co-morbid chronic obstructive pulmonary disease. Primary health outcome (routine data in a random sample of 200 patients/practice): Proportion of people with at least one unscheduled asthma consultation during the second trial year (i.e. between 12 and 24 months post-randomisation). Implementation outcome (sub-group: 20 completed questionnaires/practice): Proportion reporting ownership of an action plan (a marker for supported self-management) at 12-months post-randomisation. Other outcomes: asthma control, confidence in practice care and self-management. Intervention: Whole systems implementation strategy (including patient resources, professional training, audit/feedback, organisational strategies). Respiratory nurse specialists will facilitate implementation within practices over 12-months, encouraging adaptation of strategies to existing routines. Randomisation: On-line randomisation. 1:1 intervention (implementation strategy): control (usual care). Analysis: Intention-to-treat analysis using logistic regression with a random effect to allow for the effect of GP practices, incorporating appropriate covariates as fixed effects including stratification factors. Health economic analyses: Analysis from a UK NHS/PSS perspective, presenting incremental cost-effectiveness ratios computed on primary outcome, QALYs, a cost consequence analysis and a budget impact analysis. PG6: Process evaluation Analysis of routinely collected trial data, researcher/facilitator logs, serial semi-structured interviews with a purposive sample of stakeholders (n&asymp;20) will explore how implementation is sustained/evolves over time. In-depth case studies of six purposively selected, diverse practices will observe detailed implementation and intervention delivery (e.g. observing training, shadowing staff, documentary evidence). Questions to be addressed are: reach/potential for scaling-up, fidelity/adaptation, intervention receipt, sustainability, context. Projected outputs & dissemination plans Conference abstracts and peer-reviewed publications in high-impact journals. End-of-project workshops for participants and other stakeholders. Innovative dissemination channels of the AUKCAR (web-sites/blogs/twitter/public lectures). Co-applicants professional networks and links with guideline groups. The findings/training will be embedded into Education for Health training. Asthma UK will support dissemination to patients, public and policy makers. Benefits to patients and the NHS The proposed work is developing/testing implementation of effective but under-used self-management and thus (if successful), will be immediately available for rolling out for the benefit of people with asthma and the health service. Our implementation strategy will be designed specifically to work within the routines of NHS primary care, and our process evaluation will have addressed scaling up and sustainability. The programme will leave a legacy of resources to support roll out. The on-line educational package, developed with Education for Health, will continue to be made available; as will a tranche of trained facilitators. Digital action plans (potentially within GP on-line services), templates to facilitate provision of self-management, interpretation of routine data for audit and optimal format of feedback will continue to be applicable.

Lay abstract: Asthma UK estimates that 5 million people in the UK have asthma; with good management most should be symptom-free most of the time. Despite this 60,000 people are admitted to hospital with asthma each year; many more attend their GP for emergency care. 1,200 people die from asthma each year &ndash; many of these deaths are preventable. Supported self-management, including engaging in the discussions around a personal asthma action plan, helps people adjust treatment in response to worsening symptoms, improves day-to-day asthma control and reduces the risk of asthma attacks. However, fewer than a quarter of people replying to an Asthma UK web-survey said they had an action plan. We aim to promote a major advance in how asthma is managed in UK primary care so that fewer people have badly controlled asthma. To do this, we need to influence the organisation of primary care asthma management, the skills of healthcare professionals and resources for patients. In our preliminary work, people with asthma told us how habits, experience and professional advice helped them manage their asthma. General practitioners, nurses and staff explained how they organise asthma care in their practices and discussed the best ways of fitting supported self-management into their routines. Nurses discuss self-management within routine reviews, but lack of time is a problem. They suggested that technological solutions (such as templates; digital action plans) would be useful, but must integrate with their computer systems. We will now: 1. Prepare and try out a new integrated approach to help practices implement supported asthma self-management, incorporating: organisational strategies to promote change (e.g. audit/feedback, improved computer templates) tailored patient resources (e.g. tailored paper/electronic action plans, asthma-relevant information) behaviour-change training for nurses/doctors/staff to develop skills 2. Test the approach in a nationwide study. We will recruit 144 general practices and assign them by chance to receive either the new approach to asthma care or continue with their usual care. A facilitator will visit intervention practices over a year and discuss with them the best strategies for supporting self-management in their practice. One year after the new strategy has been introduced into practices we will use anonymous data from practice electronic records to assess benefit by measuring how many people needed emergency care for an asthma attack and the cost of providing supported self-management. We will send questionnaires to people with asthma to ask if they have an action plan and measure their asthma control, and interview professionals and patients to help us understand how and why the strategy worked or didn t. If successful our strategy and the on-line educational package, experienced facilitators, digital action plans, and review templates, will be immediately ready for roll-out to benefit people with asthma and the NHS

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY