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

NCT05226091 | Completed DMC

• 1 other identifier: 174770
• Study Type: interventional
• Target: 1,389
• Locations: 1 country
• Sites: 1

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).

Conditions

General Practice (GP), Primary Care Settings

Outcome Measures

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.

  8 weeks

Secondary Outcomes (12)

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

  8 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Usual care arm

NO INTERVENTION

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

Interventions

Letter BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• General practices who are currently contributing part of the CPRD in England.
• 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.

You may not qualify if:

• General practices that are not in England.
• General practices that are not included in the CPRD.
• Practices that cease to be part of the CPRD during the intervention time without contributing to the primary outcome.
• Practices that merge during the intervention (where the merging practices were in different study arms).
• School-aged children with asthma under 4 and over 16 years old as of 1st September 2021.
• Children with no asthma diagnosis
• Children with asthma who have not received a prescription for asthma medication. in the last 12 months

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

The University of Sheffield

Sheffield, United Kingdom

Location

Related Publications (2)

• Alyami RA, Simpson R, Oliver P, Julious SA. 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. Lancet. 2023 Nov;402 Suppl 1:S22. doi: 10.1016/S0140-6736(23)02089-5.

  PMID: 37997062 DERIVED

• 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.

  PMID: 36397087 DERIVED

Related Links

• PLEASANR Trial
• Rami's Page

MeSH Terms

Interventions

College Fraternities and Sororities

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Steven A Julious, PhD

  University of Sheffield

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 7, 2022
• Study Start: August 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 18, 2023

Record last verified: 2021-12

Locations

GB (1)