AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease (APRIL)
NCT ID: NCT05865249
Last Updated: 2024-01-16
Study Results
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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ACTIVE_NOT_RECRUITING
NA
63 participants
INTERVENTIONAL
2023-06-03
2024-04-01
Brief Summary
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Detailed Description
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The primary objective of this study is to assess the feasibility of a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry.
Endpoints of the current study will be focused on feasibility and acceptability outcomes.
Secondary objectives of this study are to collect data on potential clinical and health economic endpoints for a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. This will help determine the primary endpoint for a future trial and provide data to support a sample size calculation to ensure that any future trial will have adequate power.
This is a mixed methods randomised controlled feasibility trial. In PICO format:
Population: Individuals with respiratory symptoms referred clinically for primary care spirometry in Hillingdon, Leicestershire, West Hampshire.
Intervention: Local primary care spirometry pathway supported by additional artificial intelligence enabled software (ArtiQ.Spiro)
Control: Local primary care spirometry alone.
Outcomes: Feasibility outcomes with a particular focus on recruitment and retention, and acceptability of intervention and trial design. Clinical outcomes including referrer diagnostic performance and patient health status. Health economic outcomes including health care usage and economic modelling.
All participants will undergo their locally agreed spirometry pathway.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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Control
In participants randomised to the control group, the primary care referrer will receive the spirometry report plus any additional information as per local spirometry pathway. The primary care referrer will not receive an interpretation and quality assessment report generated by ArtiQ.Spiro.
No interventions assigned to this group
Intervention
In participants randomised to the intervention group, the primary care referrer will receive the spirometry report plus any additional information as per local spirometry pathway plus an interpretation and quality assessment report generated by ArtiQ.Spiro.
Spirometry decision support software (ArtiQ.Spiro)
ArtiQ.Spiro is a decision support software that combines two sub-components - one focussing on quality assessment (ArtiQ.QC), and one on spirometry interpretation (ArtiQ.PFT). It is intended to be used as an adjunct to spirometry to assist with the grading of spirometry quality and the interpretation of spirometry by providing the probability of six disease / or no disease categories.
Interventions
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Spirometry decision support software (ArtiQ.Spiro)
ArtiQ.Spiro is a decision support software that combines two sub-components - one focussing on quality assessment (ArtiQ.QC), and one on spirometry interpretation (ArtiQ.PFT). It is intended to be used as an adjunct to spirometry to assist with the grading of spirometry quality and the interpretation of spirometry by providing the probability of six disease / or no disease categories.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Referral by GP or nominated representative for primary care spirometry during study period.
* Patients able to provide informed consent.
Exclusion Criteria
* Any locally defined exclusion to spirometry.
18 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Gillian Doe
Leicester, , United Kingdom
Harefield Hospital
Uxbridge, , United Kingdom
Countries
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Other Identifiers
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IRAS324175
Identifier Type: -
Identifier Source: org_study_id
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