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

University of Sheffield

Status: Completed

Conditions: General Practice (GP), Primary Care Settings

Treatments: Behavioral: Letter

Study type: Interventional

Funder types: Other

Identifiers

NCT05226091

174770

Details and patient eligibility

About

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).

Enrollment: 1,389 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,389 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Letter

Usual care arm

No Intervention group

Description:

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