Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): study protocol for a cluster randomised control trial

Trials

Tjeerd vanStaa⁵  W Henry Smithson²  Paul Norman⁷  Heather Elphick⁶  Sarah Davis³  Cindy L Cooper¹  Mike J Bradburn¹  Jonathan Boote⁸  Steven A Julious⁴  Michelle J Horspool¹ 

[1] Clinical Trials Research Unit, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK;Academic Unit of Primary Medical Care, University of Sheffield, Samuel Fox House, Northern General Hospital, Herries Road, Sheffield S5 7AU, UK;Health Economics and Decision Science, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK;Medical Statistics Group, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK;Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, 5th Floor, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ, UK;Department of Paediatric Respiratory Medicine, Sheffield Children’s Hospital, Western Bank, Sheffield S10 2TH, UK;Department of Psychology, University of Sheffield, Western Bank, Sheffield S10 2TP, UK;Design, Trials and Statistics, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK

关键词: Unscheduled medical appointments;    Public health intervention;    Primary care;    Cluster randomised controlled trial;    Asthma exacerbation;    Childhood asthma;    Asthma;   

Others  :  1093054
DOI  :  10.1186/1745-6215-14-297

 received in 2013-02-21, accepted in 2013-09-04,  发布年份 2013

【 摘 要 】

Background

Within the UK, during September, there is a pronounced increase in the number of unscheduled medical contacts by school-aged children (4–16 years) with asthma. It is thought that that this might be caused by the return back to school after the summer holidays, suddenly mixing with other children again and picking up viruses which could affect their asthma. There is also a drop in the number of prescriptions administered in August. It is possible therefore that children might not be taking their medication as they should during the summer contributing to them becoming ill when they return to school.

It is hoped that a simple intervention from the GP to parents of children with asthma at the start of the summer holiday period, highlighting the importance of maintaining asthma medication can help prevent increased asthma exacerbation, and unscheduled NHS appointments, following return to school in September.

Methods/design

PLEASANT is a cluster randomised trial. A total of 140 General Practices (GPs) will be recruited into the trial; 70 GPs randomised to the intervention and 70 control practices of “usual care”. An average practice is expected to have approximately 100 children (aged 4–16 with a diagnosis of asthma) hence observational data will be collected on around 14000 children over a 24-month period. The Clinical Practice Research Datalink will collect all data required for the study which includes diagnostic, prescription and referral data.

Discussion

The trial will assess whether the intervention can reduce exacerbation of asthma and unscheduled medical contacts in school-aged children associated with the return to school after the summer holidays. It has the potential to benefit the health and quality of life of children with asthma while also improving the effectiveness of NHS services by reducing NHS use in one of the busiest months of the year.

An exploratory health economic analysis will gauge any cost saving associated with the intervention and subsequent impacts on quality of life. If results for the intervention are positive it is hoped that this could be adopted as part of routine care management of childhood asthma in general practice.

Trial registration

Current controlled trials: ISRCTN03000938 (assigned 19/10/12) http://www.controlled-trials.com/ISRCTN03000938/ webcite.

UKCRN ID: 13572

【 授权许可】

   
2013 Horspool et al.; licensee BioMed Central Ltd.

【 图 表 】

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