Clinical trial NCT05865249: AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease (APRIL)
Official title: Real-world Evaluation of an Artificial-Intelligence Support Software (ArtiQ.Spiro) in Primary Care Spirometry Pathways for the Detection of Lung Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2023-05-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years, irrespective of sex, ethnicity, disability, sexual orientation, marital status, educational level,
* Referral by GP or nominated representative for primary care spirometry during study period.
* Patients able to provide informed consent.

Exclusion Criteria:

* Age \<18yrs; Absolute contraindication to spirometry.
* Any locally defined exclusion to spirometry.

Primary outcomes:
measure: Identification and recruitment of eligible participants
timeFrame: Six months
measure: Participant retention at follow-up
timeFrame: Six months
measure: Fidelity of randomisation
timeFrame: Six months
measure: Fidelity of intervention delivery
timeFrame: Six months
measure: Contamination of control groups
timeFrame: Six months
measure: Acceptability of the intervention to referrers, spirometry practitioners and participants
timeFrame: Six months
measure: Acceptability of outcome measures and their timing
timeFrame: Six months
measure: Diagnostic accuracy of ArtiQ.Spiro compared with reference standard
timeFrame: Six months
measure: Data collector blinding
timeFrame: Six months
Secondary outcomes:
measure: Spirometry Quality Assessment Performance (vs Reference Standard)
timeFrame: Six months
measure: Primary Care Referrer Quality Assessment Confidence
timeFrame: Six months
measure: Primary Care Referrer Technical/Pattern Interpretation
timeFrame: Six months
measure: Primary Care Referrer Technical/Pattern Interpretation Confidence
timeFrame: Six months
measure: Primary Care Referrer Diagnostic Performance (versus Reference Standard)
timeFrame: Six months
measure: Primary Care Referrer Diagnostic Confidence
timeFrame: Six months
measure: Patient health status
timeFrame: Six months
measure: Heath and social care usage
timeFrame: Six months
measure: Health economic modelling
timeFrame: Six months
measure: Focus groups
timeFrame: Six months.
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Gillian Doe
city: Uxbridge
country: United Kingdom
facility: Harefield Hospital
Study officials:
References: