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

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).

Study Overview

• Status: Completed
• Conditions: General Practice (GP), Primary Care Settings
• Intervention / Treatment: Behavioral: Letter

• Study Type: Interventional
• Enrollment (Actual): 1389
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • The University of Sheffield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: Usual care arm; GP practices randomised to control will not receive either mail or email and they will continue with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	4 weeks
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.	4 weeks
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	4 weeks
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	4 weeks
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	6 months
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	4 months
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	4 months and each one of them
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)	4 months and each one of them
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	4 months and each one of them
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.	4 months and each one of them
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.	4 months and each one of them

Collaborators and Investigators

• Sponsor: University of Sheffield
• Investigators: Study Director: Steven A Julious, PhD, University of Sheffield

Publications and helpful links

General 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.

Helpful Links

• PLEASANR Trial
• Rami's Page

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 174770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No