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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
- Source :
- Smith, J R, Musgrave, S D, Payerne, E, Noble, M, Sims, E J, Clark, A B, Barton, G, Pinnock, H, Sheikh, A, Wilson, A 2018, ' 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 ', Trials . https://doi.org/10.1186/s13063-018-2816-z, Trials, Vol 19, Iss 1, Pp 1-14 (2018), Trials
- Publication Year :
- 2018
- Publisher :
- BioMed Central, 2018.
-
Abstract
- 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.
- Subjects :
- Inservice Training
Time Factors
Cost-Benefit Analysis
Video Recording
Medicine (miscellaneous)
Study Protocol
Patient Admission
0302 clinical medicine
Risk Factors
Hospitalisation
Electronic Health Records
Multicenter Studies as Topic
Pharmacology (medical)
Anti-Asthmatic Agents
Registries
030212 general & internal medicine
Cluster randomised controlled trial
Hospital Costs
Lung
Randomized Controlled Trials as Topic
lcsh:R5-920
Cost–benefit analysis
Delivery of Health Care, Integrated
Register
Treatment Outcome
Medical emergency
General practice
lcsh:Medicine (General)
Risk assessment
Record linkage
Status Asthmaticus
Disease cluster
Risk Assessment
Drug Costs
Decision Support Techniques
03 medical and health sciences
Intervention (counseling)
Pragmatic Clinical Trials as Topic
medicine
Humans
eLearning
At-risk asthma
Asthma
Protocol (science)
Primary Health Care
business.industry
Decision Support Systems, Clinical
medicine.disease
United Kingdom
Pathway of care
030228 respiratory system
business
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Smith, J R, Musgrave, S D, Payerne, E, Noble, M, Sims, E J, Clark, A B, Barton, G, Pinnock, H, Sheikh, A, Wilson, A 2018, ' 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 ', Trials . https://doi.org/10.1186/s13063-018-2816-z, Trials, Vol 19, Iss 1, Pp 1-14 (2018), Trials
- Accession number :
- edsair.doi.dedup.....ade1a9bfa8fc2c664bcd479f90c88ac0