Development and evaluation of an online FeNO-guided primary care asthma management intervention

Research question Does implementation of an optimised FeNO-guided management intervention during routine primary care asthma reviews reduce acute exacerbations of asthma? Background Inhaled corticosteroids (ICS) are the cornerstone of treatment to reduce eosinophilic airway inflammation and prevent acute exacerbations. However, despite a 30% increase in spending on ICS treatment in England since 2007, annual asthma-related mortality, hospitalisation and exacerbation rates have not improved since 2000. Most monitoring of asthma occurs in primary care, where treatment decisions are based on symptoms and lung function. However, these measures do not reliably indicate eosinophilic airway inflammation or future exacerbation risk. Fractional exhaled nitric oxide (FeNO) is a simple, non-invasive breath test which is already extensively used to assess eosinophilic airway inflammation in UK hospital settings, but rarely in primary care. The National Institute for Health and Care Excellence (NICE) recognises the value of FeNO in diagnosis of asthma, but has highlighted the need for more robust evidence to guide its use in monitoring asthma treatment. Aims and objectives To iteratively develop and refine a complex online FeNO-guided asthma management intervention for use in primary care. To determine whether our intervention is more effective than usual care in reducing acute exacerbations of asthma. To assess the cost-effectiveness of our intervention. To investigate potential influences on implementation and outcomes of our intervention in primary care. Methods To develop and refine our intervention, we will conduct systematic theory, evidence and person-based intervention planning informed by consultation with stakeholders, qualitative interviews with health care professionals and patients, and small-scale implementation in general practices. We will then evaluate the effectiveness of our intervention by conducting a pragmatic parallel randomised controlled trial (RCT) in UK general practices. To optimise our recruitment strategy and procedures, we will perform a three-month internal pilot phase, proceeding to the main phase if pre-specified progression criteria are met. We will conduct an economic evaluation based on trial findings to determine whether our intervention is cost-effective and a mixed methods process evaluation of our intervention involving quantitative process outcomes and qualitative interviews with health care professionals and patients. Timelines for delivery We will produce our optimised intervention during the first 18 months of our programme and complete the internal pilot phase of our RCT by the end of year 2, progressing to the main phase in year 3. We will aim to complete recruitment by the end of year 3 and collection of follow-up data by the end of year 4. We will complete our analysis of RCT data, economic evaluation, and process evaluation by the end of year 5. Anticipated impact and dissemination Our findings will have strong potential to influence national guidelines and clinical practice within five years of this programme being completed. We will work with policymakers and guideline developers to incorporate our findings into BTS/SIGN and NICE guidance. We will also make our online intervention freely available to health care professionals and raise awareness of our intervention through scientific publications, conference presentations, educational workshops, and patient organisations including Asthma UK.