At-Risk Registers Integrated into primary care to Stop Asthma crises in the UK
| ISRCTN | ISRCTN95472706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95472706 |
| Secondary identifying numbers | HTA 13/34/70 |
- Submission date
- 02/12/2014
- Registration date
- 05/12/2014
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Asthma is a common long-term condition that can cause coughing, wheezing, chest tightness and breathlessness. Many UK asthma patients are admitted to hospital or die every year. Current treatments should allow asthma to be controlled in most patients. However, certain asthma patients are at greater risk of being admitted or dying than others and intensive support of these patients may improve their health. This study will confirm we can improve the care of these patients, cost to the NHS, and the effect on care of other asthma patients.
Who can participate?
We will recruit 270 GP practices and expect they will identify 10,530 patients who are at risk of having severe asthma attacks.
What does the study involve?
Half of the GP practices will be randomly allocated to have a computerised alert message whenever any of the ‘at risk’ patients make contact with anyone in the practice. Practice staff will be trained on what to do when they see the alert; for example, remind receptionists to book urgent appointments; remind 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 remind pharmacists to ensure patients take their medicines. Routinely available anonymised data from patients will be collected from participating practices. Practices will be followed up for 12 months, after which we will count visits to Accident and Emergency, hospital admissions, and deaths due to asthma. We will also measure asthma control, medications prescribed, attendance for routine appointments and smoking cessation. We will calculate how much this costs and whether it improves (or interferes with) the care of other patients with asthma in the practices. With informed consent, we will arrange focus groups and interviews for patients and staff, to discuss thoughts about the at-risk registers, the training, and how it worked in practice. Patients at the other GP practices will receive care as usual.
What are the possible benefits and risks of participating?
There may be no direct benefit to participants in taking part in this research study but their involvement will give them the opportunity to have their say about their experiences of the ARRISA-UK programme and may help improve treatment for patients with asthma. We do not anticipate there being any significant risks to participant health by taking part in the study.
Where is the study run from?
Norwich Clinical Trial Unit, UEA, Norwich (UK)
When is the study starting and how long is it expected to run for?
December 2014 to October 2023
Who is funding the study?
The National Institute for Health Research Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Stanley Musgrave
Tel: +44 (0)1603 593309
arrisa-uk.med@uea.ac.uk
Contact information
Public
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
 ORCID ID |
0000-0002-4626-3469 |
|---|---|
| Phone | +44 (0)1603593309 |
| arrisa-uk.med@uea.ac.uk |
Study information
| Study design | Two-arm cluster randomized controlled multi-centre trial integrating a mixed-methods process evaluation and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 |
| Study acronym | ARRISA-UK |
| Study hypothesis | The study aims to test the hypothesis that systematically identifying patients at risk of severe exacerbations of asthma, flagging their primary care EHR to provide enduring prompts at the time of all contacts with the practice, training all practice staff about the systematic management of these patients and providing ongoing practice support will reduce crisis asthma events (asthma-related deaths, hospitalisations and A&E attendances) and be clinically acceptable and cost-effective without detriment to the care of non-at-risk asthma patients. |
| Ethics approval(s) | North Wales REC (Central & East) of the National Institute for Social Care and Health Research, UK, 26/11/2014, ref: 14/WA/1211 |
| Condition | 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) |
| Intervention | 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 System: a computerised alert 4. Practice support: phone call and video reminders The intervention will target all healthcare professionals and reception staff within the whole practice to improve the care of patients with asthma who are at high risk of crisis events related to exacerbations of their disease. The control arm will receive care as usual in the UK. |
| Intervention type | Mixed |
| Primary outcome measure | 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 outcome measures | 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, implementation and compliance. The process evaluation will also explore how key intermediary and primary and secondary outcomes (e.g. asthma control) are affected by contextual characteristics (e.g. practice characteristics), including identification of factors that will improve effectiveness and sustainability in practice. |
| Overall study start date | 01/12/2014 |
| Overall study end date | 31/10/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | The target is 270 GP practices. The number of 'at risk' asthma patients identified per practice will be determined by the practice and will vary by practice size. It is anticipated that approximately an average of 39 patients might be identified per practice, which would lead to the identification of approximately 10,530 at-risk patients |
| Total final enrolment | 168661 |
| Participant 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) |
| Participant 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. |
| Recruitment start date | 01/03/2015 |
| Recruitment end date | 31/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Norwich
NR4 7TJ
United Kingdom
Sponsor information
University/education
-
Norwich
NR4 7TJ
England
United Kingdom
| Phone | +44 (0)1603591490 |
|---|---|
| deborah.graver@uea.ac.uk | |
| Website | www.uea.ac.uk |
"ROR" |
https://ror.org/026k5mg93 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The trialists will publish the trial protocol. They will publish in high-impact peer-reviewed journals. They will attend conferences to present the findings nationally and internationally. Asthma UK, the Asthma UK Centre for Applied Research and our Hospital and University media relations departments will support the dissemination of the study outcomes with a coordinated press release and media coverage. They will use the innovative dissemination channels of the Asthma UK Centre for Applied Research (websites, public lectures and blogs) and the co-applicants' professional networks to ensure findings are both disseminated and adopted into practice if the intervention is found to be effective. Asthma UK will support dissemination to patients through their network of volunteers and members, and to professionals via their Healthcare Professional Relationships Manager. Additional or modified dissemination plans may be confirmed at a later date. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/04/2025: The intention to publish date was changed from 31/10/2024 to 31/10/2025. Total final enrolment added.
19/12/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/10/2022 to 31/10/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 31/10/2023 to 31/10/2024.
30/03/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/10/2021 to 31/10/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 31/10/2022 to 31/10/2023.
13/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2020 to 31/10/2020.
2. The overall trial end date was changed from 31/07/2020 to 31/10/2021.
3. The intention to publish date was changed from 31/07/2021 to 31/10/2022.
21/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2019 to 31/03/2020.
2. The overall trial end date was changed from 31/08/2019 to 31/07/2020.
3. The intention to publish date was changed from 31/08/2020 to 31/07/2021.
23/04/2018: The following changes were made to the trial record:
1. The target number of participants was changed from 262 GP practices and 9170 patients to 270 GP practices and 10,530 patients.
2. The recruitment end date was changed from 30/05/2018 to 30/09/2019.
04/04/2017: The overall trial end date was changed from 30/11/2018 to 31/08/2019.
