Clinical trial NCT05226091: Trial to Assess Implementation of New Research in a Primary Care Setting (TRAINS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Practice (GP), Primary Care Settings
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 1389
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Practice exclusion criteria:

  1. General practices that are not in England.
  2. General practices that are not included in the CPRD.
  3. Practices that cease to be part of the CPRD during the intervention time without contributing to the primary outcome.
  4. Practices that merge during the intervention (where the merging practices were in different study arms).
* Exclusion criteria of children with asthma:

  1. School-aged children with asthma under 4 and over 16 years old as of 1st September 2021.
  2. Children with no asthma diagnosis
  3. Children with asthma who have not received a prescription for asthma medication. in the last 12 months

Primary outcomes:
measure: The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.
timeFrame: 8 weeks
Secondary outcomes:
measure: The number of asthma preventer medication prescriptions per School-aged child with asthma patient from 1st August 2021 to 30th September 2021.
timeFrame: 8 weeks
measure: The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.
timeFrame: 4 weeks
measure: The number of prescription uptake of asthma preventer medication per patient in the month of September 2021
timeFrame: 4 weeks
measure: The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.
timeFrame: 4 weeks
measure: The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.
timeFrame: 4 weeks
measure: The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1st July 2021.
timeFrame: 6 months
measure: 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.
timeFrame: 4 months
measure: 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.
timeFrame: 4 months and each one of them
measure: 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.
timeFrame: 4 months and each one of them
measure: 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.
timeFrame: 4 months and each one of them
measure: 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.
timeFrame: 4 months and each one of them
measure: 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.
timeFrame: 4 months and each one of them
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: The University of Sheffield
Study officials:
affiliation: University of Sheffield
name: Steven A Julious, PhD
role: STUDY_DIRECTOR
References:
citation: Alyami RA, Simpson R, Oliver P, Julious SA. 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. Trials. 2022 Nov 17;23(1):947. doi: 10.1186/s13063-022-06864-y.