Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT05933694
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spirometry Interpretation Performance of Primary Care Clinicians With/Without AI Software
Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Performance of Primary Care Clinicians in the Interpretation of SPIROmetry With or Without Artificial Intelligence Decision Support Software
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRO-AID
Brief Summary:
To evaluate whether an artificial intelligence decision support software (ArtiQ.Spiro) improves the diagnostic accuracy of spirometry interpreted by primary care clinicians, as measured by Clinician Diagnostic Accuracy (vs Reference Standard).
Detailed Description:
This is a randomised controlled study to evaluate the effects of AI support software on the performance of primary care clinicians in the interpretation of spirometry. Clinicians will be provided with a clinical dataset of 50 entirely anonymous, previously recorded real-world spirometry records to interpret and will be asked to complete specific questions about diagnosis and quality assessment. The records will be randomly selected from a database comprising spirometry records from 1122 patients undergoing spirometry in primary care and community -based respiratory clinics in Hillingdon borough between 2015-2018.
Participating clinicians will be allocated at random to receive either spirometry records alone or spirometry records with the addition of an AI spirometry interpretation eport. The clinical spirometry records will be de-identified (name, date of birth, address, postcode, occupation, GP, medications data removed), by a member of the clinical care team.
Study participants (participating clinicians) will independently examine the same 50 spirometry records through an online platform. For each spirometry record, the primary care clinician participant will answer questions about technical quality, pattern interpretation, preferred diagnosis, differential diagnosis and self-rated confidence with these answers.
The study statistician will be blinded to treatment allocation up to completion of analysis and interpretation.
The reference standards for spirometry technical quality and pattern interpretation will be made by a senior experienced respiratory physiologist but without access to AI report.
The reference standard for diagnosis will be made by a panel of three respiratory specialists from the clinical care team with access to medical notes and results of relevant investigations but without access to AI report.
Participating clinicians will be allocated at random to receive either spirometry records alone or spirometry records with the addition of an AI spirometry interpretation eport. The clinical spirometry records will be de-identified (name, date of birth, address, postcode, occupation, GP, medications data removed), by a member of the clinical care team.
Study participants (participating clinicians) will independently examine the same 50 spirometry records through an online platform. For each spirometry record, the primary care clinician participant will answer questions about technical quality, pattern interpretation, preferred diagnosis, differential diagnosis and self-rated confidence with these answers.
The study statistician will be blinded to treatment allocation up to completion of analysis and interpretation.
The reference standards for spirometry technical quality and pattern interpretation will be made by a senior experienced respiratory physiologist but without access to AI report.
The reference standard for diagnosis will be made by a panel of three respiratory specialists from the clinical care team with access to medical notes and results of relevant investigations but without access to AI report.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: