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

NCT05865249 | Unknown

• 1 other identifier: IRAS324175
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Spirometry Quality Assessment Performance (vs Reference Standard)

  Six months

• Primary Care Referrer Quality Assessment Confidence

  Six months

• Primary Care Referrer Technical/Pattern Interpretation

  Six months

• Primary Care Referrer Technical/Pattern Interpretation Confidence

  Six months

• Primary Care Referrer Diagnostic Performance (versus Reference Standard)

  Six months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

OTHER

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.

Other: Spirometry decision support software (ArtiQ.Spiro)

Interventions

Spirometry decision support software (ArtiQ.Spiro) OTHER

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.

Also known as: ArtiQ.Spiro

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \<18yrs; Absolute contraindication to spirometry.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

Gillian Doe

Leicester, LE3 9QP, United Kingdom

Location

Harefield Hospital

Uxbridge, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 18, 2023
• Study Start: June 3, 2023
• Primary Completion: January 22, 2024
• Study Completion: April 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)