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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05226091
Acronym
(TRAINS)
Enrollment
1389
Registered
2022-02-07
Start date
2019-08-01
Completion date
2021-12-31
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Practice (GP), Primary Care Settings

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).

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.

Sponsors

University of Sheffield
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.8 weeksprescription uptake of asthma preventer medication for children with asthma.

Secondary

MeasureTime frameDescription
The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.4 weeksprescription uptake of asthma preventer medication per patient.
The number of prescription uptake of asthma preventer medication per patient in the month of September 20214 weeksprescription uptake of asthma preventer medication per patient.
The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.4 weeksThe proportion of children who have a prescription for asthma preventer medication per patient
The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.4 weekschildren who have a prescription for asthma preventer medication per patient
The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1st July 2021.6 monthsThe number of prescription uptake of asthma preventer medication
The number of asthma preventer medication prescriptions per School-aged child with asthma patient from 1st August 2021 to 30th September 2021.8 weekspreventer medication prescriptions per School-aged child with asthma patient.
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 2021.4 months and each one of themThe number of unscheduled medical contact per patient
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 2021.4 months and each one of themThe proportion of patients who have a medical contact (either unscheduled and scheduled)
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 2021.4 months and each one of themThe total number of medical contact (either unscheduled and scheduled) per patient
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.4 months and each one of themThe proportion of patients who have an unscheduled medical contact associated with a respiratory diagnosis.
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.4 months and each one of themThe number of unscheduled medical contacts per patient associated with a respiratory diagnosis.
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 2021.4 monthsThe proportion of patients with unscheduled medical contact

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026