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
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

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

Study information

Study design	Cluster randomised controlled trial
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
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

Sponsor information

Asthma UK (UK)
Charity

Summit House
70 Wilson Street
London
EC2A 2DB
United Kingdom

Phone	+44 (0)20 7786 4940
Email	CWright@asthma.org.uk
Website	http://www.asthma.org.uk
"ROR"	https://ror.org/03z7xev21

Funders

Funder type

Charity

Asthma UK (UK) (ref: 06/047)
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
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?
Results article	results	01/12/2012		Yes	No