NCT05226091已完成不适用
TRial to Assess Implementation of New Research in a Primary Care Setting (TRAINS): a Pragmatic Cluster Randomised Controlled Trial of an Educational Intervention to Promote Asthma Prescription Uptake in General Practitioner Practices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,389
- 试验地点
- 1
- 主要终点
- The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.
研究概览
简要总结
In England and Wales, unscheduled care for school-aged children with asthma significantly increases after their return to school in September, a trend linked with decreased asthma preventer prescriptions during the summer holidays. The PLEASANT study found that a reminder letter from GPs to parents of children with asthma led to a 30% increase in prescription uptake during August and reduced unscheduled medical visits from September to December.
The TRAINS trial will now assess if informing GPs of PLEASANT findings would lead to its implementation. This pragmatic cluster randomised implementation trial will use routine data from Clinical Practice Research Datalink (CPRD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria of practices Practices inclusion criteria
- •1- General practices who are currently contributing part of the CPRD in England.
- •Inclusion criteria of children with asthma
- •Inclusion criteria for the data extraction from CPRD:
- •1- School-aged children with asthma aged between 4 to 16 years old as of 1st September 2021 with a coded diagnosis of asthma who have been prescribed asthma medication in the last 12 months.
排除标准
- •Practice exclusion criteria:
- •General practices that are not in England.
- •General practices that are not included in the CPRD.
- •Practices that cease to be part of the CPRD during the intervention time without contributing to the primary outcome.
- •Practices that merge during the intervention (where the merging practices were in different study arms).
- •Exclusion criteria of children with asthma:
- •School-aged children with asthma under 4 and over 16 years old as of 1st September
- •Children with no asthma diagnosis
- •Children with asthma who have not received a prescription for asthma medication. in the last 12 months
结局指标
主要结局
The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.
时间窗: 8 weeks
prescription uptake of asthma preventer medication for children with asthma.
次要结局
- The number of prescription uptake of asthma preventer medication per patient in the month of September 2021(4 weeks)
- The proportion of patients with unscheduled medical contact from 1st September 2021 to 30th December 2021 and the individual months of 1st September 2021 to 31st December 2021.(4 months)
- The number of asthma preventer medication prescriptions per School-aged child with asthma patient from 1st August 2021 to 30th September 2021.(8 weeks)
- The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.(4 weeks)
- The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.(4 weeks)
- The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1st July 2021.(6 months)
- The proportion of patients who have a medical contact (either unscheduled and scheduled) from 1st September 2021 to 30th December 2021 and the individual months from 1st September 2021 to 31st December 2021.(4 months and each one of them)
- The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.(4 weeks)
- The number of unscheduled medical contact per patient from 1st September 2021 to 31th December 2021 and the individual months from 1st September 2021 to 31st December 2021.(4 months and each one of them)
- The total number of medical contact (either unscheduled and scheduled) per patient in the period 1st September 2021 to 30th December 2021 and the individual months of 1st September 2021 to 31st December 2021.(4 months and each one of them)
- The proportion of patients who have an unscheduled medical contact in the period 1st September 2021 to 30th December 2021 and the individual months of 1st September 2021 to 30th December 2021 associated with a respiratory diagnosis.(4 months and each one of them)
- The number of unscheduled medical contacts per patient and from 1st September 2021 to 30th December 2021 and the individual months of 1st September 2021 to 31st December 2021associated with a respiratory diagnosis.(4 months and each one of them)
研究者
研究点 (1)
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