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CompletedNCT05226091(TRAINS)Updated May 18, 2023

Trial to Assess Implementation of New Research in a Primary Care Setting (TRAINS)

An interventional study of Letter in General Practice (GP), Primary Care Settings, sponsored by University of Sheffield. Completed at 1 site in United Kingdom. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-05-18.

Sponsored by University of Sheffield · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Aug 2019, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
1,389
Allocation
Randomized
Ages
4 Years to 16 Years
Sex
All
01

Study 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).

02

Conditions studied

  • General Practice (GP), Primary Care Settings
03

In context

Lead sponsor

University of Sheffield is the lead sponsor of 74 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,389 participants (actual)

Study arms

  • Experimental
    Intervention arm

    GP practices randomised to the intervention will receive a mail and email about the result of the PLEASANT study and advising them to implement the study findings.

    Behavioral: Letter

  • No intervention
    Usual care arm

    GP practices randomised to control will not receive either mail or email and they will continue with usual care.

Interventions

  • BehavioralLetter

    Selected GP practices currently registered with CPRD will receive correspondence by both email and mail informing them about the result of the PLEASANT study and advising them how to implement what has been learnt. Included in the mailing would be a suggested letter and SMS text.

06

What researchers measure

Primary outcomes

  1. The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.

    prescription uptake of asthma preventer medication for children with asthma.

    Time frame: 8 weeks

Secondary outcomes

  1. The number of asthma preventer medication prescriptions per School-aged child with asthma patient from 1st August 2021 to 30th September 2021.

    preventer medication prescriptions per School-aged child with asthma patient.

    Time frame: 8 weeks

  2. The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.

    prescription uptake of asthma preventer medication per patient.

    Time frame: 4 weeks

  3. The number of prescription uptake of asthma preventer medication per patient in the month of September 2021

    prescription uptake of asthma preventer medication per patient.

    Time frame: 4 weeks

  4. The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.

    The proportion of children who have a prescription for asthma preventer medication per patient

    Time frame: 4 weeks

  5. The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.

    children who have a prescription for asthma preventer medication per patient

    Time frame: 4 weeks

  6. The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1st July 2021.

    The number of prescription uptake of asthma preventer medication

    Time frame: 6 months

  7. 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.

    The proportion of patients with unscheduled medical contact

    Time frame: 4 months

  8. 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.

    The number of unscheduled medical contact per patient

    Time frame: 4 months and each one of them

  9. 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.

    The proportion of patients who have a medical contact (either unscheduled and scheduled)

    Time frame: 4 months and each one of them

  10. 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.

    The total number of medical contact (either unscheduled and scheduled) per patient

    Time frame: 4 months and each one of them

  11. 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.

    The proportion of patients who have an unscheduled medical contact associated with a respiratory diagnosis.

    Time frame: 4 months and each one of them

  12. 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.

    The number of unscheduled medical contacts per patient associated with a respiratory diagnosis.

    Time frame: 4 months and each one of them

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Study locations

1 site
  • The University of Sheffield
    Sheffield, United Kingdom
08

References and documents

Publications

  • 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. PubMed 36397087 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05226091
Lead sponsor
University of Sheffield
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Aug 1, 2019
Primary completion
Sep 30, 2021
Completion
Dec 31, 2021
Last update
May 18, 2023

Study contacts

Steven A Julious, PhD
study director · University of Sheffield

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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