AsthmaNCT03000491
Learning Health System for Asthma
An observational study of Asthma, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 750,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2017to 30 Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (with and without asthma) in Scotland registered with primary care practices from 2010-2015.
Who may be able to join
- Patients registered with general practices across Scotland.
Who cannot join
- Patients from general practices that do not to opt-in to the study.
- Patients with a READ code recording dissent from use of their records for research purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a National Learning Health System for Asthma to Reduce the Risk of Asthma Attacks and the Risk of Asthma Hospitalisations and Deaths
This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any improvements that can be made so that they can better support people with asthma.
If successful, the investigators hope to progress to the main quality improvement phase involving an increased number of practices and then incrementally build this up to cover the whole of Scotland.
Read the detailed description
The UK has amongst the highest rates of asthma in the world as well as some of the poorest health outcomes from asthma.
Investigations into asthma deaths in the UK have found that the way patients were managed in the time leading up to their death could be improved significantly and half of asthma deaths are potentially avoidable. For most people with asthma, symptoms can come and go and sometimes be erratic. To prevent these symptoms, there is a window of opportunity to intervene with the appropriate care. This window occurs between when someone experiences early symptoms like night cough or wheeze and when they experience a full-blown asthma attack.
Most people with asthma receive care primarily in their general practice. General practices have a history of using health information technology to care for their patients. The use of this technology over time has resulted in the creation of rich electronic healthcare data. Through this rich data there are opportunities to create a system whereby clinical management can be benchmarked and improvements highlighted.
This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any improvements that can be made so that they can better support people with asthma.
If successful, the investigators hope to progress to the main quality improvement phase involving an increased number of practices and then incrementally build this up to cover the whole of Scotland.
- Conditions
- Asthma
- Being tested
- No intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called ID: AC16078 NCT03000491
Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records.
Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records.
Measured: At study completion (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start3 Mar 2017
- Primary completion31 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 750,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000491
- Sponsor's protocol ID
- AC16078
- Status last verified
- Aug 2016
- First submitted
- 6 Sep 2016
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a National Learning Health System for Asthma to Reduce the Risk of Asthma Attacks and the Risk of Asthma Hospitalisations and Deaths
- ClinicalTrials.gov ID
- NCT03000491
- Acronym / sponsor ID
- AC16078
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750,000 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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.
This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any improvements that can be made so that they can better support people with asthma.
If successful, the investigators hope to progress to the main quality improvement phase involving an increased number of practices and then incrementally build this up to cover the whole of Scotland.
Detailed description
The UK has amongst the highest rates of asthma in the world as well as some of the poorest health outcomes from asthma.
Investigations into asthma deaths in the UK have found that the way patients were managed in the time leading up to their death could be improved significantly and half of asthma deaths are potentially avoidable. For most people with asthma, symptoms can come and go and sometimes be erratic. To prevent these symptoms, there is a window of opportunity to intervene with the appropriate care. This window occurs between when someone experiences early symptoms like night cough or wheeze and when they experience a full-blown asthma attack.
Most people with asthma receive care primarily in their general practice. General practices have a history of using health information technology to care for their patients. The use of this technology over time has resulted in the creation of rich electronic healthcare data. Through this rich data there are opportunities to create a system whereby clinical management can be benchmarked and improvements highlighted.
This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any improvements that can be made so that they can better support people with asthma.
If successful, the investigators hope to progress to the main quality improvement phase involving an increased number of practices and then incrementally build this up to cover the whole of Scotland.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (with and without asthma) in Scotland registered with primary care practices from 2010-2015.
Key inclusion criteria (1 listed)
- Patients registered with general practices across Scotland.
Key exclusion criteria (2 listed)
- Patients from general practices that do not to opt-in to the study.
- Patients with a READ code recording dissent from use of their records for research purposes.
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 |
|---|---|---|
| No interventionAlso: ID: AC16078 NCT03000491Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records. | Other | – |
Primary outcome
Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records.
Time frame: At study completion (3 months)
Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records.
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 17 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Edinburgh 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 1 inclusion and 2 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 17 May 2024. 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?
Variations in clinical practice as assessed by data relating to asthma extracted from patient electronic health records. (time frame: At study completion (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2024; AzTrials last refreshed its copy on 4 Nov 2026.