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Protocolled practice nurse-led care for children with asthma in primary care: protocol for a cluster randomised trial
Sara Bousema1, Annemieke J Verwoerd2, Lucas M Goossens3
1General Practice, Erasmus MC, Rotterdam, The Netherlands s.bousema@erasmusmc.nl.
Insights
Protocolled practice nurse-led asthma care in primary care may improve asthma control in children. This study compares nurse-led care to usual care to assess effectiveness in managing childhood asthma symptoms and exacerbations.
Area of Science:
- Pediatric respiratory medicine
- Primary care management
- Nursing interventions
Background:
- Childhood asthma significantly impacts quality of life for children and families.
- Current primary care for pediatric asthma faces challenges of both undertreatment and overtreatment.
- Adult studies suggest regular medical reviews improve asthma control, but physician-led protocols may be resource-intensive.
Purpose of the Study:
- To evaluate if protocolled practice nurse-led asthma care in primary care improves asthma control in children compared to usual care.
- To assess the effectiveness of nurse-led interventions in managing pediatric asthma.
- To provide evidence for potential guideline revisions in childhood asthma management.
Main Methods:
- A cluster-randomised open-label trial with 18-month follow-up.
- 180 children aged 6-12 years with asthma will be included, with practice nurses as units of randomisation.
- Primary outcome: average asthma control measured by the Childhood Asthma Control Test (C-ACT); secondary outcomes include exacerbations, quality of life, and cost-effectiveness.
Main Results:
- This section is to be filled once the study results are available.
- The study is designed to measure the primary outcome of average asthma control via C-ACT over 18 months.
- Secondary outcome analysis will include C-ACT scores at multiple time points, exacerbation rates, and quality of life measures.
Conclusions:
- This is the first trial assessing protocolled practice nurse-led asthma care for children in primary care.
- Findings may inform improvements in pediatric asthma management strategies.
- Results could be directly applicable to updating asthma care guidelines for children.
Introduction:
In children with asthma, daily symptoms and exacerbations have a significant impact on the quality of life of both children and parents. More effective use of asthma medication and, consequently, better asthma control is advocated, since both overtreatment and undertreatment are reported in primary care. Trials in adults suggest that asthma control is better when patients receive a regular medical review. Therefore, protocolled care by the general practitioner may also lead to better asthma control in children. However, such protocolled care by the general practitioner may be time consuming and less feasible. Therefore, this study aims to determine whether protocolled practice nurse-led asthma care for children in primary care provides more effective asthma control than usual care.
Methods And Analysis:
The study will be a cluster-randomised open-label trial with an 18-month follow-up. Practice nurses will be the units of randomisation and children with asthma the units of analysis. It is planned to include 180 children aged 6-12 years. Primary outcome will be average asthma control during the 18-month follow-up measured by the Childhood Asthma Control Test (C-ACT). Secondary outcomes include C-ACT scores at t=3, t=6, t=12 and t=18 months; the frequency and severity of exacerbations; cost-effectiveness; quality of life; satisfaction with delivered care; forced expiratory volume in 1 s and forced expiratory flow at 75% and the association of high symptoms scores at baseline and baseline characteristics. Besides, we will conduct identical measurements in a non-randomised sample of children.
Ethics And Dissemination:
This will be the first trial to evaluate the effectiveness of protocolled practice nurse-led care for children with asthma in primary care. The results may lead to improvements in asthma care for children and can be directly implemented in revisions of asthma guidelines.The study protocol was approved by the Medical Research Ethics Committee of the Erasmus Medical Centre in Rotterdam.
Trial Registration:
NTR6847.
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