Evaluation of the impact of letters to GP practices to promote asthma prescription uptake in school-age children during summer (TRAINS study): a pragmatic cluster-randomised controlled trial.

BACKGROUND: Asthma exacerbations peak in school-aged children after the return to school in September. Previous studies have shown a decline in collections of asthma prescriptions during August. The PLEASANT trial demonstrated that sending a reminder letter to parents increased prescription uptake; reduced unscheduled care, and was cost saving to the health service. We aimed to assess whether informing general practitioner (GP) practices about the PLEASANT trial and its results could lead to its implementation in routine practice. METHODS: The trial to assess implementation of new research in a primary care setting (TRAINS) was a pragmatic cluster-randomised (1:1) trial conducted in England involving GP practices contributing to the Clinical Practice Research Datalink (CPRD). The intervention was a letter informing the GP practice of the PLEASANT trial results with recommendations for implementation. GP practices in the control group continued with usual care without receiving any letters about PLEASANT trial. The intervention was distributed via CPRD by both mail and email in June 2021. The trial received both University of Sheffield Ethics approval and Independent Scientific Advisory Committee (ISAC) approval. The primary outcome was the proportion of children with asthma (aged 4-15 years) who had a prescription for a preventer between Aug 1 and Sept 30, 2021. This trial is registered with ClinicalTrials.gov, NCT05226091. FINDINGS: A total of 1326 GP practices, including 90 583 children with asthma, were included in the study. These practices were randomly allocated to the intervention group (664 practices, 44 708 children) or the control group (662 practices, 45 875 children). In assessing the impact of the intervention on the proportion of children collecting a preventer prescription, 15 716 (35·3%) of 44 708 children from the intervention group and 16 001 (35·1%) of 45 559 children from the control group picked up a prescription. There was no statistically significant difference observed (odds ratio [OR] 1·01, 95% CI 0·97-1·05), indicating that the intervention had no effect. INTERPRETATION: The study findings suggest that passive intervention of providing a letter to GPs did not achieve the intended outcomes. To bridge the gap between evidence and practice, alternative, more proactive strategies could be explored to address the identified issues. FUNDING: Jazan University.

TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in general practitioner practices.

BACKGROUND: There is a marked increase in unscheduled care visits in school-aged children with asthma after returning to school in September. This is potentially associated with children not taking their asthma preventer medication during the school summer holidays. A cluster randomised controlled trial (PLEASANT) was undertaken with 1279 school-age children in 141 general practices (71 on intervention and 70 on control) in England and Wales. It found that a simple letter sent from the family doctor during the school holidays to a parent with a child with asthma, informing them of the importance of taking asthma preventer medication during the summer relatively increased prescriptions by 30% in August and reduced medical contacts in the period September to December. Also, it is estimated there was a cost-saving of £36.07 per patient over the year. We aim to conduct a randomised trial to assess if informing GP practices of an evidence-based intervention improves the implementation of that intervention. METHODS/DESIGN: The TRAINS study-TRial to Assess Implementation of New research in a primary care Setting-is a pragmatic cluster randomised implementation trial using routine data. A total of 1389 general practitioner (GP) practices in England will be included into the trial; 694 GP practices will be randomised to the intervention group and 695 control group of usual care. The Clinical Practice Research Datalink (CPRD) will send the intervention and obtain all data for the study, including prescription and primary care contacts data. The intervention will be sent in June 2021 by postal and email to the asthma lead and/or practice manager. The intervention is a letter to GPs informing them of the PLEASANT study findings with recommendations. It will come with an information leaflet about PLEASANT and a suggested reminder letter and SMS text template. DISCUSSION: The trial will assess if informing GP practices of the PLEASANT trial results will increase prescription uptake before the start of the school year. The hope is that the intervention will increase the implementation of PLEASANT work and then increase prescription uptake during the summer holiday prior to the start of school. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05226091.