At-Risk Registers Integrated into primary care to Stop Asthma crises in the UK

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95472706

Enrollment

9170

Registered

2014-12-05

Start date

2015-03-01

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma care in general practice, specifically the prevention of severe exacerbations of asthma that lead to crisis asthma events (asthma-related deaths, hospitalisations and A&E attendances) Respiratory Asthma

Interventions

This is a complex intervention comprising the following four components: 1. Establishment of register of at-risk patients 2. Practice-wide internet-based training 3. Computerised Decision Support Sys

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The unit of randomisation is the cluster (or GP practice). The only inclusion criterion for the clusters is that they are General Practices within the UK 2. The individual participants (for the purpose of the primary endpoint) within the clusters are patients with asthma 3. In addition, for the purposes of process evaluation and health economic analysis practice staff will also be included as participants (as we require data from these individuals)

Exclusion criteria

Exclusion criteria: The unit of randomisation is the cluster (or GP practice). The exclusion criteria for the clusters are: 1. Practices already implementing a formal prospective process of identification of patients with at- risk asthma and practice wide targeting of asthma care on every approach to patient or their record 2. Practices hosting or affected by research which might significantly influence the practice-wide process of care of patients with ‘at-risk’ asthma The individual participants within the clusters also have exclusion criteria: 1. Patients with recorded refusal for use of anonymous data in research 2. Terminally ill patients receiving palliative care only In addition for the purposes of the focus groups and interviews we have the following exclusion criteria: 1. Patients less than 16 years of age 2. Patients unable to communicate in English.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the difference in the proportion of at-risk patients (as identified by the initial search) who have an asthma-related crisis event (A&E attendance, hospitalisation or death) in the 12 months from the date the flags go live on the computer system in the intervention practices compared to the control group practices.	—

Secondary

Measure	Time frame
1. The time to first asthma-related crisis event for at-risk patients 2. The percentage of all patients with an asthma-related crisis event and the time to first of these events 3. The percentage of all asthma patients with good control – answering no to all of the 'RCP 3 questions for asthma' (difficulty sleeping, daytime symptoms, interference with usual activities) 4. The percentage of all patients with asthma with a hospital admission or death for any reason 5. The number of the following (per patient per year) for both at-risk asthma patients and all asthma patients: 5.1. Short-acting bronchodilator prescriptions issued 5.2. Prescriptions of systemic corticosteroids for asthma exacerbations and antibiotic-treated lower respiratory tract infections 5.3. Modifications of the prescription of asthma-related medications to align more closely with current guidelines (e.g. increased use of inhaled corticosteroids) 5.4. Written personalised asthma action plans and patient self-monitoring with peak flow diaries 5.5. Inhaler technique assessments recorded 5.6. Smoking cessation advice or smoking cessation medications 5.7. Flu vaccinations The rate of the following (per patient per year) 5.8. 'Did not attend' at primary and secondary care routine appointments 5.9. Adherence to medication determined from validated computer-based calculations from prescription data Health economic outcome The main outcome measure in the economic analysis will be based on the primary outcome for the study. The number of asthma-related crisis events will be estimated for both study arms. The incremental effect will be the estimated mean difference (between arms) in number of asthma crisis events, after taking account of clustering. Process evaluation outcomes The outcomes include quantitative and qualitative assessments of the views of healthcare professionals and patients, practice procedures and processes of care, staff behaviours and awareness, and indicators of intervention uptake, i	—

Measure

Time frame

1. The time to first asthma-related crisis event for at-risk patients 2. The percentage of all patients with an asthma-related crisis event and the time to first of these events 3. The percentage of all asthma patients with good control – answering no to all of the 'RCP 3 questions for asthma' (difficulty sleeping, daytime symptoms, interference with usual activities) 4. The percentage of all patients with asthma with a hospital admission or death for any reason 5. The number of the following (per patient per year) for both at-risk asthma patients and all asthma patients: 5.1. Short-acting bronchodilator prescriptions issued 5.2. Prescriptions of systemic corticosteroids for asthma exacerbations and antibiotic-treated lower respiratory tract infections 5.3. Modifications of the prescription of asthma-related medications to align more closely with current guidelines (e.g. increased use of inhaled corticosteroids) 5.4. Written personalised asthma action plans and patient self-monitoring with peak flow diaries 5.5. Inhaler technique assessments recorded 5.6. Smoking cessation advice or smoking cessation medications 5.7. Flu vaccinations The rate of the following (per patient per year) 5.8. 'Did not attend' at primary and secondary care routine appointments 5.9. Adherence to medication determined from validated computer-based calculations from prescription data Health economic outcome The main outcome measure in the economic analysis will be based on the primary outcome for the study. The number of asthma-related crisis events will be estimated for both study arms. The incremental effect will be the estimated mean difference (between arms) in number of asthma crisis events, after taking account of clustering. Process evaluation outcomes The outcomes include quantitative and qualitative assessments of the views of healthcare professionals and patients, practice procedures and processes of care, staff behaviours and awareness, and indicators of intervention uptake, i

—

Countries

England, United Kingdom

Contacts

Public ContactStanley Musgrave

arrisa-uk.med@uea.ac.uk+44 (0)1603593309

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026