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 prescription uptake in General Practitioner Practices

Study type
Protocol
Date of Approval
Study reference ID
21_000436
Lay Summary

There is a noticeable increase in unscheduled care after they return to school in September in school-aged children with asthma in the UK. It has been shown that this increase is preceded by, and is associated with, a drop in asthma preventer prescription uptake during the summer holidays in children. This led to the motivation for the PLEASANT study (Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term) which was a trial to assess if a letter sent from general practitioners (GPs) to parents of school-aged children at the start of the summer vacation reminding them of the importance of continuing to take their medication during the summer holidays.
The results from PLEASANT showed that the letter increased prescription uptake in August by 30%. It reduced the unscheduled medical visits after the return to school in the period of September to December.
The plan is to investigate the effectiveness of sharing the information from PLEASANT with general practitioners through the TRAINS (Trial to Assess Implementation of New research in a primary care Setting) trial. The study will assess the effectiveness of informing GPs about the PLEASANT results through a randomised trial: half the practices will be in the intervention group and half will be the usual care. We will use the Clinical Practice Research Datalink (CPRD) to assist in sending the intervention and collect data including prescription uptake and unscheduled hospital visits.

Technical Summary

In school-aged children with asthma, there is a marked increase in unscheduled care after the return to school in September. This is associated with children not taking their asthma preventer medication during the school summer holidays.
A cluster randomised controlled trial (PLEASANT; Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term) was undertaken in 141 general practices (71 on intervention, and 70 on the control) in England and Wales. It was found that a simple letter sent from the family doctor sent during the school holidays to a parent with a child with asthma informing them of the importance of taking asthma medication prior to the start of the school year relatively increased prescriptions by 30% in the month prior to the start of the school year.
The TRAINS (Trial to Assess Implementation of New research in a primary care Setting) trial will assess if informing GP practices of the results of the PLEASANT trial will increase prescription uptake prior to the start of the school year. The investigation will be through a randomisation controlled trial with half the practices getting the intervention and half not. The hope is the intervention will increase implementation of the work of PLEASANT and as a result increase prescription uptake during the summer holiday prior to the start of the school. The assumption would be an increase in prescriptions uptake is associated with GP practices implementing the results of PLEASANT. CPRD will be used to obtain all data for the study which includes prescription, and primary care contacts data and to assist in the sending of the intervention.

Health Outcomes to be Measured

Primary outcome measure
 The proportion of children with asthma who have a prescription for an asthma preventer medication in the months of 1 August 2021 to 30 September 2021.
Secondary outcome measures
1. The number of prescriptions of asthma preventer medication per School-aged child with asthma patient in in the period 1 August 2021 to 30 September 2021.
2. The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.
3. The number of prescription uptake of asthma preventer medication per patient in the month of September 2021.
4. The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.
5. The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.
6. The number of prescription uptake of asthma preventer medication per patient in the month of September 2021.
7. The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1 July 2021.
8. The proportion of patients who have an unscheduled medical contact in the period in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
9. The number of unscheduled medical contact per patient in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
10. The proportion of patients who have a medical contact (either unscheduled and scheduled) in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
11. The total number of medical contact (either unscheduled and scheduled) per patient in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
12. The proportion of patients who have an unscheduled medical contact in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021 associated with respiratory diagnosis.
13. The number of unscheduled medical contacts per patient and in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021associated with respiratory diagnosis.

Collaborators

Steven Julious - Chief Investigator - University of Sheffield
Rami Alyami - Corresponding Applicant - University of Sheffield
Phillip Oliver - Collaborator - University of Sheffield
Rebecca Simpson - Collaborator - University of Sheffield
Tony Stone - Collaborator - University of Sheffield

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation