NCT05865249

AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease (APRIL)

Real-world Evaluation of an Artificial-Intelligence Support Software (ArtiQ.Spiro) in Primary Care Spirometry Pathways for the Detection of Lung Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the feasibility of performing a future real-world randomised controlled trial to determine the clinical effectiveness of ArtiQ.Spiro in supporting diagnostic performance of primary care staff in the interpretation of spirometry

Detailed description

This is a feasibility study for a larger multicentre randomised controlled trial (RCT) assessing the impact of the ArtiQ.Spiro software on diagnostic accuracy, care processes, patient and health economic outcomes. 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

• Lung Diseases

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-06-03
• Primary completion: 2024-01-22
• Completion: 2024-04-01
• First posted: 2023-05-18
• Last updated: 2024-01-16

Locations

2 sites across 1 country: United Kingdom