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

Lung Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05865249
• Other study ID #: IRAS324175
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: April 1, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Gillian Doe	Leicester
United Kingdom	Harefield Hospital	Uxbridge

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and recruitment of eligible participants	Contributing data: Screening & recruitment log and trial consort diagram. Progression criteria: Green (=80% screened eligible, =60% eligible recruited), Amber (60-79% screened eligible, 40 - 59% eligible recruited), Red (<60% screened eligible, <40% eligible recruited)	Six months
Primary	Participant retention at follow-up	Contributing data: Participation data and Trial Consort diagram. Progression criteria: Green (=75% retained at 3 months, =60% retained at 6 months), Amber (60-75% retained at 3 months, 40-59% retained at 6 months), Red (<60% retained at 3 months, <40% retained at 6 months).	Six months
Primary	Fidelity of randomisation	Contributing data: Numbers randomised to control/intervention groups and baseline distribution of characteristics of intervention and control groups.; Progression criteria: Green: <10% difference in sample size, proportion of women, proportion of non-white ethnicity, proportion of > 65 years between control/intervention for each site. Amber: <15% difference in above criteria; Red: >15% difference in above criteria.	Six months
Primary	Fidelity of intervention delivery	Contributing data: Email Logs, and Primary Care Referrer Questionnaire. Progression Criteria: Green (=90% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, =90% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Amber (85-94% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, 75-89% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Red (<85% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, <75% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation).	Six months
Primary	Contamination of control groups	Contributing data: Email Logs. Progression Criteria: Green (=10% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report). Amber (11-15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report) Red (>15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report)	Six months
Primary	Acceptability of the intervention to referrers, spirometry practitioners and participants	Contributing data: Stakeholder focus groups. Progression criteria: Green (Reported as acceptable (or can be with minimal modification). Amber (Reported as acceptable with modification).Red (Intervention not acceptable).	Six months
Primary	Acceptability of outcome measures and their timing	Contributing data: Stakeholder focus groups, and Clinical Outcome Measure collection. Progression criteria: Green (Reported as acceptable or can be with minimal modification, Missing data of =10% for each measure).Amber (Reported as acceptable with modification, 11-25% missing data for each measure). Red: (Intervention not acceptable, >25% missing data for each measure).	Six months
Primary	Diagnostic accuracy of ArtiQ.Spiro compared with reference standard	Contributing data: Diagnostic accuracy of ArtiQ.Spiro compared with reference standard. Progression criteria: Green: = 80%, Amber: 65-79%, Red: <65%.	Six months
Primary	Data collector blinding	Contributing data: Participation data. Progression criteria: Green (Blinding maintained for =85% participants), Amber (Blinding maintained for 84-70%), Red (Blinding maintained for <70%).	Six months
Secondary	Spirometry Quality Assessment Performance (vs Reference Standard)	Referrers will be asked to rate the quality of the spirometry of the participant (Acceptable, usable, unusable/unacceptable) based on spirometry report (with or without ArtiQ.Spiro report). This will the be compared with Reference Standard(panel of specialists)	Six months
Secondary	Primary Care Referrer Quality Assessment Confidence	Referrers will be asked to rate the confidence in their quality assessment on a Likert scale (from 0: Very unsure to 10: Very confident).	Six months
Secondary	Primary Care Referrer Technical/Pattern Interpretation	Referrer will be asked to provide their Technical/Pattern Interpretation of the spirometry report received (Normal, Obstructive, Restrictive, Mixed), and their confidence in their technical/pattern interpretation.	Six months
Secondary	Primary Care Referrer Technical/Pattern Interpretation Confidence	Referrers will be asked to rate their confidence in their Technical/Pattern Interpretation on a Likert scale (from 0: Very unsure to 10: Very confident).	Six months
Secondary	Primary Care Referrer Diagnostic Performance (versus Reference Standard)	Referrers will be asked to provide a preferred diagnosis based on spirometry report (with/without ArtiQ.Spiro report) and information from primary care records.	Six months
Secondary	Primary Care Referrer Diagnostic Confidence	Referrers will be asked to rate the confidence in their diagnosis on a continuous visual analogue scale (from 0: Very unsure to 10: Very confident).	Six months
Secondary	Patient health status	Health Status will be measured by the EQ5D5L at baseline, 3 and 6 months post spirometry.	Six months
Secondary	Heath and social care usage	This will be measured using a Patient Healthcare Resource Use Questionnaire at baseline, 3 and 6 months post spirometry.	Six months
Secondary	Health economic modelling	The health economic analysis will compare health-related costs and benefits of ArtiQ.Spiro supported spirometry with standard spirometry pathways, as observed within the study.	Six months
Secondary	Focus groups	Three focus groups will be conducted, comprising trial patient participants, primary care referrers and spirometry practitioners. These will be used to assess feasibility and acceptability of the trial procedures, intervention, trial outcomes.	Six months.