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
DOI https://doi.org/10.1186/ISRCTN36918958
Protocol serial number 06/047
Sponsor Asthma UK (UK)
Funder Asthma UK (UK) (ref: 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

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

Study information

Primary study designInterventional
Study designCluster randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymARRISA (At-Risk Registers In Severe Asthma study)
Study objectivesCompared 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) studiedAsthma
InterventionPractices 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 typeOther
Primary outcome measure(s)

Moderate-severe asthma exacerbations, measured at one year.

Key secondary outcome measure(s)

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.

Completion date28/02/2010

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration524
Key inclusion criteriaPRACTICES:
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 criteriaPRACTICES:
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 enrolment01/03/2007
Date of final enrolment28/02/2010

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

School of Medicine
Norwich
NR4 7TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 Yes No
BMC - Part of Springer Nature Springer Nature