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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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General Practice (GP), Primary Care Settings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Letter

Intervention Type 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.

Usual care arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Letter

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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

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).

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No