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)

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 ≤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 ≥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 re