Prescription Alerts for Reliever inhalers in Children (PARC) project
| ISRCTN | ISRCTN12460754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12460754 |
| IRAS number | 332076 |
| Secondary identifying numbers | CPMS 60369, IRAS 332076 |
- Submission date
- 15/03/2024
- Registration date
- 04/07/2024
- Last edited
- 26/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Many children and teenagers have asthma; a long-term lung condition causing wheezing and breathlessness. Severe asthma attacks may need hospital treatment and can be life-threatening. Two types of inhalers are used to treat asthma: relievers and preventers. Children using high numbers of reliever inhalers are more likely to have severe asthma attacks. It has therefore been recommended that these children should have an urgent check-up. This does not yet routinely happen. This study aims to determine whether children (aged 1-17 years) prescribed 7 or more reliever inhalers in the past year invited to an enhanced nurse-led check-up will have fewer asthma attacks in the following year.
Who can participate?
Children aged 1-17 years old who have been prescribed 7 or more reliever inhalers in the past year
What does the study involve?
General practices across the Wessex and Thames Valley regions will randomly be divided into two groups:
1. Practices offering enhanced asthma check-ups (intervention practices).
2. Practices providing usual asthma care (control practices).
Practices will be asked to identify children aged 1-17 years who have been prescribed 7 or more reliever inhalers in the past year. In intervention practices, these children will be invited for an asthma check-up. This will be undertaken by a specially trained general practice nurse. At the check-up, the team will explore reasons for poor asthma control including symptom triggers, prescribed asthma treatment and whether treatments are taken as prescribed. The children's inhaler techniques will also be checked and families will be provided with an asthma action plan.
At the end of the project, the number of severe asthma attacks in a year in children from intervention and usual care practices will be compared. The study will also evaluate the cost-effectiveness of providing enhanced check-ups to children prescribed high numbers of reliever inhalers and will talk to some children, their parents and health professionals about their experience of the check-up. This will help with introducing them into routine practice if they prove effective.
What are the possible benefits and risks of participating?
Taking part in this project may improve participants’ asthma control and reduce their chance of having asthma attacks in the future. It may also improve their quality of life as asthma can affect people’s sleep and ability to take part in activities e.g. sports. Their participation will also help to improve our understanding of how to manage asthma in children and young people and therefore, may benefit others. If participants attend a check-up, they will be given a £5 voucher as a thank-you for their time.
There are minimal risks associated with taking part in this project. The check-up is similar to a standard annual asthma check-up but will be longer and more detailed. No new medications are being tested and no tests will be performed.
Where is the study run from?
University Hospital Southampton NHS Foundation Trust
When is the study starting and how long is it expected to run for?
May 2022 to January 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) programme
Who is the main contact?
Dr Anna Selby, parc@soton.ac.uk
Contact information
Public, Scientific, Principal Investigator
Academic Clinical Lecturer, LF81, F level, South Academic Block, Southampton General Hospital, Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0003-4044-7125 |
|---|---|
| Phone | None provided |
| parc@soton.ac.uk |
Study information
| Study design | Parallel-group cluster-randomized wait-list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice, Home, Hospital, Medical and other records, Other therapist office, Telephone |
| Study type | Treatment |
| Participant information sheet | 45188_PIS[16-17 years]_v1.1_30Jan2024.pdf |
| Scientific title | Reducing severe asthma exacerbations by using prescription alerts for excessive reliever inhaler use to target high-risk children: a randomised controlled trial |
| Study acronym | PARC |
| Study hypothesis | Targeted and enhanced asthma/wheeze reviews in high-risk children will prevent severe asthma/wheeze attacks and are cost-effective |
| Ethics approval(s) |
Approved 13/03/2024, West of Scotland Research Ethics Service (Research Ethics, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 24/WS/004 |
| Condition | Paediatric asthma |
| Intervention | 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 participant identification centres (PICs) and be randomised to intervention and control arms. Intervention practices will perform searches every 3 months for 12 months to identify children prescribed 7 or more short-acting beta-agonist (SABA) reliever inhalers in the previous 12 months. Children who meet the study inclusion criteria will be offered an enhanced asthma review. This will be 30 minutes in duration and will be undertaken by a specially trained primary care nurse at one of the following locations: • The Clinical Research Facility (CRF) at University Hospital Southampton NHS Foundation Trust (UHS). • Research hubs within the Wessex Clinical Research Network (CRN). • Research buses operated by the Wessex CRN. • The David Hide Asthma and Allergy Research Centre, St Mary’s Hospital, Newport, Isle of Wight. • The Royal Berkshire Hospital, Reading. • General practices with clinic room space. Home visits/virtual reviews will also be offered to families who would not otherwise be able to take part in the project. In accordance with British Thoracic Society guidelines and The National Asthma Care Bundle, asthma reviews will cover the following areas: - Patient/carer's understanding of what asthma is, what the symptoms are and how it is treated. - Current symptom control including frequency of reliever inhaler use, number of attacks/ED attendances/courses of oral corticosteroids in the past year. The asthma control test/children's asthma control test will be completed. - Symptom triggers/environmental factors e.g. pet and smoke exposure. - Other health problems that may affect asthma control e.g. allergic rhinitis and obesity. - Asthma treatment including adherence and inhaler technique. - Psychosocial factors e.g. stress at home/school and lack of engagement with health care. - Education and supported self-management including provision of an asthma action plan. Participants/their parents will be contacted via telephone call approximately 4-8 weeks after their asthma review to check progress with their action plan and ensure that further follow-up by the participant’s GP is arranged if necessary. Control practices will perform searches in the same way as intervention practices, but they will start them 12 months later. The same qualifying period will be used to allow a controlled comparison. For example, for intervention practices starting screening on 01/01/2024, the qualifying period will be the previous 12 months (01/01/2023 to 31/12/2023). Control practices will start screening 12 months later (01/01/2025) but will use the same qualifying period ending 12 months earlier (01/01/2023 to 31/12/2023). Children from control practices who have 7 or more SABA inhaler prescriptions during the qualifying period will be offered an asthma review once outcome data has been collected. The above approach to recruitment has been chosen to ensure that data on SABA inhaler prescriptions and follow-up data are collected during the same time period in participants from intervention and control practices. Semi-structured interviews with a selection of participants/their parents in the intervention group will be undertaken approximately one month after their follow-up phone call. The aim of these is to seek an in-depth understanding of families’ perception of the intervention and identify facilitators and barriers to implementation. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/05/2022 |
| Overall study end date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 614; UK Sample Size: 614 |
| Participant 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) |
| Participant 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. |
| Recruitment start date | 01/07/2024 |
| Recruitment end date | 30/09/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southampton
SO16 6YD
United Kingdom
Newport
PO30 5TG
United Kingdom
Reading
RG1 5AN
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department, Duthie Building, MP 138, Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381205044 |
|---|---|
| sponsor@uhs.nhs.uk | |
| Website | https://www.uhs.nhs.uk/ |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Our publication and dissemination plans are as follows: 1. Planned publication in a high-impact peer-reviewed medical journal 2. Presentations at relevant conferences e.g. the Primary Care Respiratory Society (PCRS) and Royal College of Paediatrics and Child Health (RCPCH) annual meetings. 3. A training package for primary care nurses to enable the intervention to be delivered. 4. A lay summary accessible via the Asthma+ Lung UK website. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 30/01/2024 | 17/05/2024 | No | Yes |
| Participant information sheet | version 1.1 | 30/01/2024 | 17/05/2024 | No | Yes |
| Participant information sheet | version 1.1 | 30/01/2024 | 17/05/2024 | No | Yes |
| Participant information sheet | version 1.1 | 31/01/2024 | 17/05/2024 | No | Yes |
| Participant information sheet | version 1.2 | 03/05/2024 | 26/07/2024 | No | Yes |
| Participant information sheet | version 1.2 | 03/05/2024 | 26/07/2024 | No | Yes |
| Participant information sheet | version 1.2 | 03/05/2024 | 26/07/2024 | No | Yes |
Additional files
- 45188_PIS[16-17 years]_v1.1_30Jan2024.pdf
- 45188_PIS[Older Children]_v1.1_30Jan2024_.pdf
- 45188_PIS[Parents]_v1.1_30Jan2024_.pdf
- 45188_PIS[Younger Children]_v1.1_31Jan2024.pdf
- ISRCTN12460754_PIS[16-17 years]_v1.2_03May2024.pdf
- ISRCTN12460754_PIS[Older Children]_v1.2_03May2024.pdf
- ISRCTN12460754_PIS[Parents]_v1.2_03May2024.pdf
Editorial Notes
26/07/2024: Patient information sheets were added for 16-17 years, older children and parents.
15/03/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
