At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK): study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations

Background Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events. Methods We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with ‘at-risk asthma’ identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients’ records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted. Discussion This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes. Trial registration ISRCTN95472706. Registered on 5 December 2014. Electronic supplementary material The online version of this article (10.1186/s13063-018-2816-z) contains supplementary material, which is available to authorized users.

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PID https://www.doi.org/10.1186/s13063-018-2816-z
PID pmid:30157917
PID urn:uri:85cd0751-d8ed-4aa4-8679-bcc347cd42f8
PID pmc:PMC6116486
URL http://hdl.handle.net/20.500.11820/4e815df4-ac71-44a3-b1e5-192549167967
URL http://europepmc.org/articles/PMC6116486
URL https://ueaeprints.uea.ac.uk/id/eprint/68182/
URL https://www.phc.ox.ac.uk/publications/912130
URL https://qmro.qmul.ac.uk/xmlui/handle/123456789/51625
URL https://www.pure.ed.ac.uk/ws/files/74825239/At_risk_registers_integrated_into_primary_care....pdf
URL https://www.ncbi.nlm.nih.gov/pubmed/30157917
URL http://dx.doi.org/10.1186/s13063-018-2816-z
URL http://link.springer.com/article/10.1186/s13063-018-2816-z
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URL https://aura.abdn.ac.uk/handle/2164/11451
URL https://dx.doi.org/10.1186/s13063-018-2816-z
URL https://ueaeprints.uea.ac.uk/68182/
URL https://abdn.pure.elsevier.com/en/publications/at-risk-registers-integrated-into-primary-care-to-stop-asthma-cri
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URL https://www.research.ed.ac.uk/portal/files/74825239/At_risk_registers_integrated_into_primary_care....pdf
URL https://academic.microsoft.com/#/detail/2889511683
URL https://eprints.soton.ac.uk/426596/
URL https://www.research.ed.ac.uk/portal/en/publications/atrisk-registers-integrated-into-primary-care-to-stop-asthma-crises-in-the-uk-arrisauk(4e815df4-ac71-44a3-b1e5-192549167967).html
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URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2816-z
URL https://pubmed.ncbi.nlm.nih.gov/30157917/
URL http://link.springer.com/content/pdf/10.1186/s13063-018-2816-z.pdf
URL https://doaj.org/toc/1745-6215
URL https://doi.org/10.1186/s13063-018-2816-z
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Author Smith, Jane R.
Author Musgrave, Stanley
Author Payerne, Estelle
Author Noble, Michael
Author Sims, Erika J.
Author Clark, Allan B.
Author Barton, Garry
Author Pinnock, Hilary
Author Sheikh, Aziz
Author Wilson, Andrew M., 0000-0002-5514-4867
Author On behalf of the ARRISA-UK Group
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Collected From Europe PubMed Central; Edinburgh Research Explorer; PubMed Central; ORCID; Datacite; e-Prints Soton; UnpayWall; DOAJ-Articles; Crossref; Microsoft Academic Graph; University of East Anglia digital repository; Oxford University Research Archive
Hosted By Europe PubMed Central; Edinburgh Research Explorer; Trials; e-Prints Soton; University of East Anglia digital repository; Oxford University Research Archive
Publication Date 2018-08-29
Publisher Springer Science and Business Media LLC
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Country United Kingdom
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Source https://science-innovation-policy.openaire.eu/search/publication?articleId=dedup_wf_001::03027de47e36cc45150997cb52c9db8f
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Last Updated 27 December 2020, 02:54 (CET)
Created 27 December 2020, 02:54 (CET)