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

Abstract

Abstract 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