General Practice (GP), Primary Care Settings(TRAINS)NCT05226091
Trial to Assess Implementation of New Research in a Primary Care Setting (TRAINS)
A study testing Letter in people with General Practice (GP), Primary Care Settings, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- General Practice (GP), Primary Care Settings
- What is being tested?
- Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,389 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria of practices Practices 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.
Who cannot join
- Practice exclusion criteria:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- Letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
preventer medication prescriptions per School-aged child with asthma patient.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 months and each one of them
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Aug 2019
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for General Practice (GP), Primary Care SettingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven A Julious, PhD, Study director, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226091
- Sponsor's protocol ID
- 174770
- Acronym
- (TRAINS)
- Status last verified
- Dec 2021
- First submitted
- 11 Jan 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alyami RA, Simpson R, Oliver P, Campbell R, Julious SA. A letter intervention to GPs practices to promoting prescription uptake in school-age children with asthma during summer holidays (TRAINS study): a pragmatic cluster randomised controlled trial. NPJ Prim Care Respir Med. 2026 Feb 10;36(1):12. doi: 10.1038/s41533-025-00475-1.
PubMed 41667505Alyami 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.
PubMed 37997062Alyami 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.
PubMed 36397087
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05226091
- Acronym / sponsor ID
- (TRAINS) / 174770
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,389 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: LetterGP 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. |
| Usual care arm | No intervention | –GP practices randomised to control will not receive either mail or email and they will continue with usual care. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Inclusion criteria of practices Practices 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.
Key exclusion criteria (8 listed)
- Practice exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetterSelected 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. | Behavioural | Intervention arm |
Primary outcome
The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.
Time frame: 8 weeks
prescription uptake of asthma preventer medication for children with asthma.
12 secondary outcomes
The number of asthma preventer medication prescriptions per School-aged child with asthma patient from 1st August 2021 to 30th September 2021.
Time frame: 8 weeks
The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.
Time frame: 4 weeks
The number of prescription uptake of asthma preventer medication per patient in the month of September 2021
Time frame: 4 weeks
The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.
Time frame: 4 weeks
The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.
Time frame: 4 weeks
The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1st July 2021.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months and each one of them
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 41667505Alyami RA, Simpson R, Oliver P, Campbell R, Julious SA. A letter intervention to GPs practices to promoting prescription uptake in school-age children with asthma during summer holidays (TRAINS study): a pragmatic cluster randomised controlled trial. NPJ Prim Care Respir Med. 2026 Feb 10;36(1):12. doi: 10.1038/s41533-025-00475-1.
- Derived from this study: PubMed 37997062Alyami 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.
- Derived from this study: PubMed 36397087Alyami 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.
- PLEASANR TrialLink provided by the sponsor.
- Rami's PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Julious, PhD study director
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter in people with General Practice (GP), Primary Care Settings, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226091, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.