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Spirometry Interpretation Performance of Primary Care Clinicians With/Without AI Software (SPIRO-AID)

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ClinicalTrials.gov Identifier: NCT05933694
Recruitment Status : Recruiting
First Posted : July 6, 2023
Last Update Posted : February 16, 2024
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lung Disease Other: Artificial Intelligence-powered Spirometry Interpretation Report Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 27, 2023
Estimated Primary Completion Date : June 27, 2024
Estimated Study Completion Date : September 30, 2024
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Participants to report 50 spirometry records alone
Experimental: Intervention
Participants report the same 50 spirometry records provided in the control arm with an artificial intelligence-powered spirometry interpretation report
 Other: Artificial Intelligence-powered Spirometry Interpretation Report
A report generated by artificial intelligence powered software that assessed technical quality of spirometry and estimates the diagnostic probability of six categories: COPD/Asthma/ILD/ Normal/Other obstructive/Other Unidentified
Other Name: ArtiQ.Spiro


Outcome Measures
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Primary Outcome Measures :
  1. Preferred Diagnostic Performance [ Time Frame: Six months ]
    A correct case is where the preferred diagnosis matches the reference final diagnosis. Units will be percentage of total cases that are correct.


Secondary Outcome Measures :
  1. Pattern interpretation [ Time Frame: Six months ]
    A correct case is where the participants' selected pattern matches the reference pattern. Options are: Normal, Airflow obstruction, Possible restriction or non-specific pattern, Possible Mixed Disorder. Units will be percentage of total cases that are correct.

  2. Differential diagnostic performance [ Time Frame: Six months ]
    A correct case is where the preferred or differential diagnosis matches the reference final diagnosis. Units will be percentage of total cases that are correct.

  3. Quality assessment performance [ Time Frame: Six months ]
    A correct case is where the participant's quality grade matches the reference quality grade. Options are: Acceptable (Grade A/B) or Not Acceptable (Grades C/D/E/F/U). Units will be percentage of total cases that are correct.

  4. Pattern interpretation self-rated confidence [ Time Frame: Six months ]
    Pattern interpretation self-rated confidence will be measured on a visual analogue scale (0-10) where 0 = not confident at all; 10= very confident)

  5. Diagnostic self-rated confidence [ Time Frame: Six months ]
    Diagnostic self-rated confidence will be measured on a visual analogue scale (0-10) where 0 = not confident at all; 10= very confident)

  6. Quality Assessment self-rated confidence [ Time Frame: Six months ]
    Quality Assessment self-rated confidence will be measured on a visual analogue scale (0-10) where is 0 = not confident at all; 10= very confident)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Clinicians working in primary care (for at least 50% of their job plan) in the UK, who refer for or perform spirometry (typically GP, practice nurse)
  2. Able to access spirometry traces on study platform
  3. Provide written informed consent via study platform

Exclusion Criteria:

1. Clinicians who have completed specialist training in respiratory medicine and recognised by the General Medical Council with a right to practise as a NHS consultant in respiratory medicine

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933694


Contacts
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Contact: Ethaar El-Emir, PhD 01895 823737 ext 85952 e.el-emir@rbht.nhs.uk
Contact: George Edwards, MSc 01895 823737 G.Edwards2@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton & Harefield Hospitals Recruiting
Uxbridge, United Kingdom, UB9 6JH
Contact: Ethaar El-Emir, PhD    01895 823737 ext 85952    e.el-emir@rbht.nhs.uk   
Contact: George Edwards, MSc    01895 823737    G.Edwards2@rbht.nhs.uk   
Principal Investigator: William Man         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: William Man Royal Brompton & Harefield Hospitals
More Information
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05933694    
Other Study ID Numbers: 323361
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases