A cluster randomised controlled trial to assess the effectiveness and costs of implementing asthma risk registers to identify and improve management of high risk asthma patients in primary care
ISRCTN | ISRCTN36918958 |
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DOI | https://doi.org/10.1186/ISRCTN36918958 |
Secondary identifying numbers | 06/047 |
- Submission date
- 04/05/2007
- Registration date
- 30/05/2007
- Last edited
- 19/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Jane Smith
Scientific
Scientific
School of Medicine
Health Policy and Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Study information
Study design | Cluster randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Screening |
Scientific title | |
Study acronym | ARRISA (At-Risk Registers In Severe Asthma study) |
Study objectives | Compared to routine care, the implementation and use of primary care-based registers of patients at high risk from severe and life-threatening exacerbations of asthma will: 1. Reduce exacerbations in these patients 2. Result in overall reduced healthcare costs associated with managing these patients |
Ethics approval(s) | Approval received from the Norfolk Research Ethics Committee on the 11th December 2006. Current protocol with minor amendments approved on 3rd March 2007 (ref: 06/Q0101/200). |
Health condition(s) or problem(s) studied | Asthma |
Intervention | Practices randomised to the intervention arm will add at-risk asthma patients to an at-risk register. Identified patients will be added to an asthma risk register involving: 1. Electronic tagging of each patients record on the practice computer system with a customisable alert (e.g. high risk asthma patient, prioritise appointment) that needs actively clearing from the screen whenever the record is called up, and 2. Placing a similar marker in patients written records This designation will be made available to all practice staff and, where possible, out-of-hours services. In addition, all staff will be given a one hour training session, delivered by a General Practitioner (GP) (Dr Mike Noble) and asthma nurse (Ms Jenny Windley) experienced in implementing and using an asthma risk register at their practice, on the relevance of the alerts and action to be taken when a high risk patient contacts the practice. |
Intervention type | Other |
Primary outcome measure | Moderate-severe asthma exacerbations, measured at one year. |
Secondary outcome measures | 1. Exacerbations from: 1.1. Death or hospitalisation 1.2. Emergency attendance (at the hospital, the practice or via a home visit) 1.3. Out-of-hours medical contact 1.4. A course of oral prednisolone or a boost in oral steroids for those receiving them regularly 2. Asthma-related routine primary and secondary care attendances and medication use 3. Healthcare costs All secondary outcomes measured at one year. |
Overall study start date | 01/03/2007 |
Completion date | 28/02/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Other |
Sex | Both |
Target number of participants | 24 - 36 practices (416 - 524 patients) |
Key inclusion criteria | PRACTICES: 1. Participation is open to all practices with adequate computer systems which are used to support routine consultations 2. Practices covering urban and rural populations, deprived and affluent areas and various practice sizes and set-ups PATIENTS: High risk patients aged 5+ years at participating practices will, according to British asthma guideline recommendations, be identified on the basis of having: 1. Severe asthma, recognised by one or more of: 1.1. Previous near-fatal asthma 1.2. Hospital admission for asthma in the last five years 1.3. Two or more attendances at Accident and Emergency (A&E) or out-of-hours services for asthma in the last year 1.4. Requiring step four or five treatment 1.5. Brittle asthma PLUS: 2. A record in the notes (of patients or their primary carers for children) of adverse behavioural or psychosocial characteristics including one or more of: 2.1. Poor adherence to recommended management 2.2. Failure to attend primary care or hospital appointments 2.3. Self-discharge from hospital 2.4. Psychosis, depression, other psychiatric illness or deliberate self-harm 2.5. Current or recent major tranquiliser use 2.6. Alcohol or drug abuse 2.7. Denial 2.8. Obesity 2.9. Learning difficulties 2.10. Employment problems 2.11. Income problems 2.12. Social isolation 2.13. Childhood abuse 2.14. Severe domestic, marital or legal stress |
Key exclusion criteria | PRACTICES: Those with pre-existing at-risk asthma registers or similar strategies to study intervention. PATIENTS: Patients who meet the inclusion criteria but are felt not appropriate to be included on an at-risk register for some other factor will be individually negotiated. |
Date of first enrolment | 01/03/2007 |
Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Medicine
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Sponsor information
Asthma UK (UK)
Charity
Charity
Summit House
70 Wilson Street
London
EC2A 2DB
United Kingdom
Phone | +44 (0)20 7786 4940 |
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CWright@asthma.org.uk | |
Website | http://www.asthma.org.uk |
https://ror.org/03z7xev21 |
Funders
Funder type
Charity
Asthma UK (UK) (ref: 06/047)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Asthma UK, Asthma + Lung UK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2012 | Yes | No |