Condition category
Respiratory
Date applied
04/05/2007
Date assigned
30/05/2007
Last edited
19/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jane Smith

ORCID ID

Contact details

School of Medicine
Health Policy and Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

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 measures

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

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

http://www.asthma.org.uk

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

Results - basic reporting

Publication summary

1. 2012 results in www.ncbi.nlm.nih.gov/pubmed/22941976

Publication citations

  1. 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.

Additional files

Editorial Notes