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Prescription Alerts for Reliever inhalers in Children (PARC) project

Reducing severe asthma exacerbations by using prescription alerts for excessive reliever inhaler use to target high-risk children: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12460754
Enrollment
614
Registered
2024-07-04
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric asthma Respiratory

Interventions

This is a parallel-group, cluster-randomised controlled trial with a waiting-list control design. General practices across Hampshire, the Isle of Wight and the Thames Valley region will act as parti

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 1-17 years old 2. 7 or more prescriptions of SABA inhalers e.g. salbutamol during the qualifying period (previous 12 months for the intervention group, 24-12 months previously for the control group) 3. Informed consent from parent/guardian/participant with assent from participant where appropriate (Children do not need to have a recorded diagnosis of asthma to be eligible to participate in the project)

Exclusion criteria

Exclusion criteria: 1. Other (in addition to asthma) long-term respiratory condition e.g. cystic fibrosis. 2. Enrolled in another interventional research study. 3. Participant or parent/guardian unable to communicate sufficiently (with an interpreter where available) to complete consent forms and have an asthma review.

Design outcomes

Primary

MeasureTime frame
Number of severe asthma attacks measured using data collected from medical records during the 12 months following the asthma review (intervention group), or during the 12 months before the asthma review (control group)

Secondary

MeasureTime frame
The following secondary outcomes will be measured using data collected from medical records during the 12 months following the asthma review (intervention group), or the 12 months before the asthma review (control group): 1. Number of SABA inhalers prescribed 2. Asthma treatment including inhaled corticosteroid dose 3. Number of hospital admissions due to asthma 4. Asthma-related health care visits in primary and secondary care (including ED attendances). Health economic evaluation: Healthcare costs and benefits will be compared in the intervention and control groups. This will cover the cost of the intervention, asthma medications, scheduled and unscheduled asthma-related primary care visits, asthma-related ED visits, inpatient care and outpatient hospital care. Process evaluation: 1. The views of 20-30 parents and 10-15 young people (aged 12 or more) from the intervention arm will be collected approximately one month after their involvement in the project 2. The views of 10-15 healthcare professionals from intervention practices will be collected at the end of the practice's involvement in the project

Countries

England, United Kingdom

Contacts

Public ContactAnna Selby
parc@soton.ac.ukNone provided

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026