Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06/047
Study information
Scientific title
Acronym
ARRISA (At-Risk Registers In Severe Asthma study)
Study hypothesis
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
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).
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2007
Overall trial end date
28/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
24 - 36 practices (416 - 524 patients)
Participant 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.
Recruitment start date
01/03/2007
Recruitment end date
28/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Medicine
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
Asthma UK (UK)
Sponsor details
Summit House
70 Wilson Street
London
EC2A 2DB
United Kingdom
+44 (0)20 7786 4940
CWright@asthma.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Asthma UK (UK) (ref: 06/047)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in www.ncbi.nlm.nih.gov/pubmed/22941976
Publication citations
-
Results
Smith JR, Noble MJ, Musgrave S, Murdoch J, Price GM, Barton GR, Windley J, Holland R, Harrison BD, Howe A, Price DB, Harvey I, Wilson AM, The at-risk registers in severe asthma (ARRISA) study: a cluster-randomised controlled trial examining effectiveness and costs in primary care., Thorax, 2012, 67, 12, 1052-1060, doi: 10.1136/thoraxjnl-2012-202093.