Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001056583
Ethics application status
Approved
Date submitted
1/08/2024
Date registered
30/08/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
30/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a lung health check for middle-aged adults.
Scientific title
Evaluating the feasibility, acceptability and fidelity of a lung health calculator in primary care for middle-aged adults: Pilot of PRECURSOR (Predicting your risk of airway obstruction).
Secondary ID [1] 312513 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Pretesting PRECURSOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 334104 0
Tobacco dependence 334521 0
Condition category
Condition code
Respiratory 330776 330776 0 0
Chronic obstructive pulmonary disease
Public Health 331138 331138 0 0
Health promotion/education
Mental Health 331360 331360 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“PRECURSOR” (PREdiCting YoUR patients’ riSk of Airways ObstRuction) is an online calculator that makes predictions about the chance of having a common, yet serious lung condition called chronic obstructive pulmonary disease (C-O-P-D) over the next ten years. It forms the basis of a COPD risk assessment for patients aged 40-49 years who are listed as current or past smokers in their electronic health record in the practice. All eligible people will be invited via SMS text message to receive adjunctive preventive healthcare in the form of this COPD risk assessment, similar to web-based risk calculators used to manage risk factors to prevent heart disease and diabetes.

For patients aged between 40 and 49 years and not had a breathing test called spirometry to look for COPD before, they can complete PRECURSOR. In this piloting study, consented patient-participants who smoke or have smoked will be individually asked around 15 questions and some sub-questions about themselves and their health during a 20-minute phone/video interview in a single session. This will be completed together with the Project coordinator at the practice site who is a non-clinician with over 10 years’ experience of working in general practice. At the end of these questions, the calculator will provide a prediction of the participating-patients’ chance of having COPD over the next ten years. If they currently smoke, another prediction will be provided which shows the reduction in risk if they could quit smoking.

Individualised feedback will be given to the participating patients by the Project coordinator, based on a pre-prepared “feedback and action” script that will be approved for use by the doctors of the pilot practice. A pdf report of the patients’ responses and their prediction will be downloaded and inserted into the patients’ electronic medical record and doctor’s inbox for further evaluation. A follow-up appointment may be arranged in pre-determined situations, at which time, the participating GP may act depending on the participating patients’ smoking status, COPD-risk prediction and/or new symptoms, if any, as they deem appropriate. Overall, the duration of the interview is expected to take between 15 to 25 minutes.

Up to 30 patients will be recruited over a 4-6-week period by the Practice coordinator. Prior to GP enrolment, the Practice coordinator will attend Project Management Team meetings via zoom with pre-reading of the protocol (approx. 12 – 15 hours) and will also receive 1 – 1.5 hours of face-to-face training approx. 4 weeks and 1 week prior to the first participant enrolment. Intervention adherence by the participating GPs will be recorded by the Practice coordinator in close consultation with the Project Lead, and both will report regularly to the Principal Investigator. Intervention adherence by the participating GPs will be enhanced by group and individual training sessions, and informal discussion/s by the Practice coordinator and Project Lead with the practice manager ± GPs: 1) after the initial recruitment of 2-6 patient-participants; and 2) intermittently during the recruitment period. Participating GPs will receive reimbursements that are fitting for their time including 30-minute interviews at the end of the study. Similarly, the participating patients will be offered an honorarium for attending an one-hour focus group/interview at the end of the 4-6 month study.
Intervention code [1] 328820 0
Early detection / Screening
Intervention code [2] 328821 0
Prevention
Intervention code [3] 328822 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338603 0
Number and proportion of consented participants who complete PRECURSOR.
Timepoint [1] 338603 0
Entered after completing the intervention with each patient-participant
Total counted 6-8 weeks post-intervention commencement i.e., at the end of the intervention phase.
Primary outcome [2] 338604 0
Participants' shift in "keenness to quit" by 0.5 units among people who currently smoke.
Timepoint [2] 338604 0
Post-intervention (2-5 days) and end of the evaluation phase (4-6 months post intervention).
Secondary outcome [1] 436549 0
Number of smoking cessation interventions with clinician.
Timepoint [1] 436549 0
End of the evaluation phase (4-6 months post intervention).
Secondary outcome [2] 437673 0
Users' experience with PRECURSOR.
Timepoint [2] 437673 0
Surveys post-intervention (2-5 days) and end of the evaluation phase (4-6 months post intervention).
Interviews +/- focus group meeting at the end of the evaluation phase (4-6 months post intervention).

Eligibility
Key inclusion criteria
1. Aged 40 -49 years.
2. Listed as a “current smoker” or “ex-smoker” in their electronic medical records (EMR), or smoking status is not recorded.
3. An “active” patient (i.e., attended the practice at least once in the last 7 years).
Minimum age
40 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of COPD documented in their EMR.
2. Preventive care is inappropriate e.g., receiving end-of-life care.
3. Unable to provide informed consent e.g., congnitively impaired.
4. Unable to participate sufficiently into video interview.
5. Patients who have not consented to receive SMS text messages from the practice

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Summary statistics of quantitative data (numbers and percentages, means and standard deviations), stratified by current smoking.
Coding and thematic analysis of qualitative data using NVivo software. The research team will review and discuss emerging themes on how to best improve PRECURSOR’s prototype and workflows.
This pilot study is investigating the uptake of the intervention so the number of the participants is a primary outcome. The number of "up to 30 patient-participants" is based on recruiting 3-4 GPs who will have consented to review up to 10 patients each.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316734 0
Government body
Name [1] 316734 0
National Health and Medical Research Council (NHMRC)
Country [1] 316734 0
Australia
Funding source category [2] 316779 0
Other Collaborative groups
Name [2] 316779 0
The Royal Australian College of General Practitioners (RACGP)
Country [2] 316779 0
Australia
Primary sponsor type
University
Name
Univeristy of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318998 0
None
Name [1] 318998 0
Address [1] 318998 0
Country [1] 318998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315508 0
Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee
Ethics committee address [1] 315508 0
Ethics committee country [1] 315508 0
Australia
Date submitted for ethics approval [1] 315508 0
06/05/2024
Approval date [1] 315508 0
13/06/2024
Ethics approval number [1] 315508 0
KH02554

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134918 0
Dr Jennifer Perret
Address 134918 0
Level 3, 207 Bouverie Street, The University of Melbourne, Victoria 3010
Country 134918 0
Australia
Phone 134918 0
+61 417898572
Fax 134918 0
Email 134918 0
[email protected]
Contact person for public queries
Name 134919 0
Jennifer Perret
Address 134919 0
Level 3, 207 Bouverie Street, The University of Melbourne, Victoria 3010
Country 134919 0
Australia
Phone 134919 0
+61 417898572
Fax 134919 0
Email 134919 0
[email protected]
Contact person for scientific queries
Name 134920 0
Jennifer Perret
Address 134920 0
Level 3, 207 Bouverie Street, The University of Melbourne, Victoria 3010
Country 134920 0
Australia
Phone 134920 0
+61 417898572
Fax 134920 0
Email 134920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This pilot study that "pre-tests" the intervention will inform on improvements in PRECURSOR's user experience, user interface and integration into the workflow of a general practice. Thus, individual participant data will not be shared outside of the research team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24060Ethical approval    387965-(Uploaded-18-07-2024-13-23-06)-24-202_Dr K Hancock_130624.pdf



Results publications and other study-related documents

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