Abstract
BackgroundDespite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based ‘goal-focused’ intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT).Methods/DesignA pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial will be collected to inform the future RCT.DiscussionThis work will lay the foundations for a definitive RCT of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013.Trial registrationCurrent Controlled Trials ISRCTN43606442
Highlights
Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal
This work will lay the foundations for a definitive randomized controlled trial (RCT) of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis
Interpretation of the Australian research was complicated by the lack of true comparison populations, but despite this, the findings suggest that the intervention could potentially improve allergic rhinitis management
Summary
Allergic rhinitis is a long-term condition with a high prevalence (estimated at 26% in the UK [1]) that has increased substantially in recent years [2]. Two previous Australian studies suggested that a community pharmacy-delivered goal-focused approach has the potential to improve outcomes for patients with allergic rhinitis [19,20,21]. We will collect quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial, to inform a future full scale trial Study materials for this pilot trial will be based on those used in the Australian studies [19,20,21]. Aims and research questions The aims are to adapt and pilot a community pharmacydelivered, goal-focused intervention for the self-management of intermittent allergic rhinitis in Scotland, based on previous research in Australia, and to collect data to inform a future definitive Scottish RCT. Study design The ‘Help for Hay Fever’ study is a pilot cluster RCT with associated preliminary economic analysis and an embedded qualitative study involving semi-structured follow-up interviews with a sub-sample of participants
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