Title: At-Risk Registers Integrated into primary care to Stop Asthma crises in the UK (ARRISA-UK): A pragmatic cluster randomised trial with nested economic and process evaluations examining the effects of integrating at-risk asthma registers into primary care with internet-based training and support
Funder: Department of Health and Social Care

Abstract: Design: Pragmatic cluster randomised controlled trial of a complex intervention with nested mixed methods process and economic evaluations. Setting: UK general practices Literature review: A search of Medline with combinations of terms relating to primary care, risk registers and asthma revealed no relevant papers other than our studies (Smith 2012; Noble 2006); furthermore, there are no relevant studies registered in clinical trial databases. Target population: Patients at high risk of asthma exacerbations/death Inclusion/exclusion: 262 primary care practices, excluding practices with existing formal, prospective processes for targeting patients with at-risk asthma. All the patients identified as having at-risk asthma according to a validated algorithm (n=9170) will be included, except those with recorded refusal for use of anonymous data in research. Health technology: At-risk registers will be created using automated electronic searches identifying at-risk criteria. Training will be delivered via web-based eLearning modules and “webinars” to representatives of all categories of practice staff to train them on how to respond to electronic alerts/flags to ensure best practice care. The flags will tag the electronic health records of at-risk patients to alert all staff at all patient-practice interactions. A practice based study lead will receive email reminders at 6 weeks and 6 months. Control: Control practices will continue routine care, including Quality and Outcome Framework driven practice-based annual asthma reviews and patients’ use of routine and emergency primary and secondary care services as required the but not the flagging or training. Measurements: The primary outcome is the difference in the proportion of at-risk patients with an asthma-related crisis event (A&E attendance, hospitalisation or death) over 12 months. Secondary outcomes: time to first crisis event, asthma control, prescribed medications, medication adherence, smoking status, all cause admission and death, health care costs in all and “at-risk” asthma patients. Anonymous routinely-collected clinical data from patients will be captured. Health economic analysis will be from an NHS perspective, where the measure of effectiveness will be based on the primary outcome measure. Routine data on processes of care, and questionnaires from practice staff completed before, during and after the training and after 12 months of the intervention, plus exit focus groups and interviews will contribute to the process evaluation. Sample size: In order to have 90% power to detect a difference in primary outcome from 7% to 5% assuming an average cluster size of 35 (ICC 0.01) we require a minimum of 235 clusters and 8204 patients. To allow-for 10% drop-out we will recruit 262 clusters, 9170 patients. Project timetables: Regulatory approvals (-6 to 0 months), production and evaluation of training programme in one region (0 to 6 months), recruitment of practices (2 to 12 months), training (9 to 24 months), follow up (21 to 36 months), focus groups (30 to 36 months), completion/cleaning dataset (37-42mth), analysis & report (42-48mth). Expertise in team: Expertise in patient and public involvement (PPI), primary and secondary care physicians with research and clinical interest in at-risk asthma, health technology assessments, pragmatic cluster randomised controlled trials, statistics, health economics, qualitative research and comprehensive evaluation of complex intervention.

Lay abstract: Unfortunately, far too many patients with asthma are admitted to hospital (approximately 72,000) or die (approximately 1150) unnecessarily in the UK every year. We have excellent drugs available for asthma and clear advice on prescribing them that should allow asthma to be controlled in most patients. It is known that certain asthma patients are at greater risk of being admitted or dying than others and that targeting intensive support and care to these patients improves their health. We have undertaken a study that identified ‘at-risk’ patients within GP practices and used computer-based systems to create pop-up alerts when these patients contact the practice. Practice staff were trained on what to do when they see the alert. This didn’t reduce the total number of attacks but reduced the hospital admissions as more patients appeared to receive appropriate treatment for their asthma. Based on these promising findings we wish to undertake a nationwide study to confirm that we can improve the care of these patients without costing the NHS too much or affecting the care of other asthma patients within GP practices. We will identify 9170 patients who are at risk of having severe asthma attacks from 262 GP practices in six regions within the UK, by searching their practice records for factors that predict risk of attacks. In half of the GP practices, a pop-up alert will appear on the computerised medical notes whenever any of the ‘at-risk’ patients make contact with anyone in the practice. This alert will, for example, remind receptionists to book urgent appointments, GPs and nurses to advise patients to take their medication and follow their written asthma action plans (personalised documents which advise patients what to do when their asthma gets worse or better) and pharmacists to ensure patients take their medicines. All practice staff will receive training on how to respond to the alerts, supported by web-based resources and practice study champions, with reminders at 6 weeks and 6 months. We will use data available routinely from the GP practice and will not need to collect information directly from patients for our study. After 12 months, we will count how many patients attended Accident and Emergency, had a hospital admission, or died due to asthma in each group. We will also find out how many people have well controlled asthma, what medications are prescribed for asthma, how often patients attend routine appointments and if they stop smoking. We will calculate how much this costs and whether it improves (or interferes with) the care of other patients with asthma in the practice. We will work out which patients gain the most from our study. With their permission, we will arrange focus groups and interview for patients and staff, to discuss their thoughts about the at-risk registers and the training and how it worked in practice. We are a team of experts and together have all of the skills required to undertake this type of study. We have conducted the previous study that this builds on and are aware of potential problems and solutions. We have carefully sought advice from patients with asthma. We are confident that, if the results of this study are positive, we will be able to ensure that our method of treating patients is available to all practices within the UK where comparable health records are used.

Research activity codes: 4.4 POPULATION SCREENING;7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY