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Trial registered on ANZCTR


Registration number
ACTRN12621000629831p
Ethics application status
Not yet submitted
Date submitted
24/11/2020
Date registered
26/05/2021
Date last updated
26/05/2021
Date data sharing statement initially provided
26/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
RECAP - A real life implementation study on management of chronic obstructive pulmonary disease (COPD) and high risk asthma in general practice.
Scientific title
Addressing the burden of respiratory disease in General Practice: The effect of a clinical audit intervention on crisis events in high risk asthma and COPD patients.
Secondary ID [1] 302858 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease(COPD) 319856 0
asthma 319857 0
Condition category
Condition code
Respiratory 317790 317790 0 0
Chronic obstructive pulmonary disease
Respiratory 317791 317791 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project focuses on preventing high cost/high burden respiratory events through the harnessing, coordination, dissemination and scaling up of an evidence-based clinical audit model (OPC Clinical Audit) into general practice. It utilises technology, digital health (including patient report outcomes) and clinical decision support systems (CDSS) to support upscaling. It aligns with national strategies for quality improvement in general practice, hence utilised current general practice infrastructure.
This study will take the form of a parallel, repeated measure, real-world study design in which patients at risk will be compared between the OPC Clinical Audit Group or the Usual Care Group (see below). The study period for each patient enrolled will be 12 months. Practices and thus patients will be recruited into one of two groups: The OPC Clinical Audit Group or the Usual Care Group. While data collection for the OPC Clinical Audit Group will be prospective for 12 months, data collection for the Usual Care Group will occur at 12 months and be retrospective.

The OPC Clinical Audit consists of the following 2-staged processes:
1. The secure and confidential extraction of data from all patients with asthma and/or COPD from the practice, including a screen for undiagnosed COPD
2. The collection of patient-reported outcomes as per the evidence-based Patient Questionnaire. From these processes a list of patients at high risk of exacerbations/undiagnosed COPD will be automatically generated.
3. Face-to-face review of high-risk patients (identified above) with the practice nurse, followed up with a consultation with the GP utilising clinical decision support advice from OPC.
These processes are discussed in further detail below.
Data Extraction: Two data screening and extraction processes from electronic medical records will be carried out in parallel: high-risk exacerbation and high risk undiagnosed COPD patients will be identified using data screening and extraction with reference to the key inclusion criteria of this study.

The following patient information will be extracted from primary care records:
1. demographics (gender, ethnicity, year of birth, suburb of residence),
2. medication prescribed (including dose, repeats and quantity),
3. diagnoses, consultations (including reasons,
4. type of provider e.g. doctor or nurse), pathology tests (ordered and results),
5. imaging test (orders and results),
6. referrals to a specialist (or other health care providers),
7. patient assessments and management (e.g. asthma plans, GP Management Plans, etc),
8. medical history (previous diagnoses and medicines),
9. health information (health weight, blood pressure, smoking status).

Patient Questionnaires: Validated questionnaires which collect data relating to the patient’s respiratory clinical status, smoking status, allergic rhinitis status, medication use, side effects, medication use, medication beliefs and adherence will be collected. These will be distributed to patients through an automated process; the general practice will dispatch electronic questionnaires via email to all respiratory patients (as per inclusion criteria). Patients will complete the questionnaires online.
Data collected from the extraction process and patient questionnaires will be combined by OPC Australia through an automated, algorithm, which based on current COPD and asthma management guidelines for the identification of high risk patients and evidence for the identification of patients with undiagnosed COPD from general practice records. The respiratory risk algorithm, will generate a report which identified patients at high risk of respiratory exacerbations and high risk of undiagnosed COPD. Identified patients will be contacted by the practice and invited to have attend the general practice for respiratory review.

Face-to-face respiratory review: The practice nurse will conduct the first phase of the respiratory review. It is anticipated that the face to face respiratory review with the practice nurse will take 30 minutes. Practice nurses will collect additional data to complement that data extracted from medical records and collected through patient questionnaires. Addition data will include: oral and intranasal inhaler administration technique, fractional exhaled nitric oxide (FeNO) and spirometry including inspiratory flow rate. Patient data collected from the face-to-face respiratory review will be recorded in the patient’s electronic health record and automatically added to the respiratory risk algorithm in order to determine a list of recommendations for management. These recommendations will provided to the GP, in order for him/her to determine any management decisions (or in terms of COPD diagnosis, to be able to make a diagnostic decision) for each individual patients. These recommendations are aligned with the objectives and management principles outlined in the National Asthma Strategy 2018 and the National Strategic Action Plan for Lung Conditions 2018; they are underpinned by the management principles outlined in the National Asthma Management Guidelines (2018) and the Australian and New Zealand Guidelines for the management of COPD (COPD-A X Plan). A consultation with the GP in which recommendations will be discussed by the GP with the patient will follow the completion of their face-to-face respiratory review. The recommendations presented will enable the delivery of a high quality, precision medicine approach to the management.

Patients who receive the OPC Clinical Audit will be followed up in 12 months, with a second OPC Clinical Audit, at which time the same 2-staged process will be implemented. This means that the OPC Clinical Audit is both a clinical management tool and an evaluation tool, which can monitor patient outcomes and impact of the audit over time.

General practices will be assigned to either the OPC Clinical Audit Group or the Usual Care Group. OPC Clinical Audit Group and Usual Care Group will be geographically separated and mutually exclusive.


Intervention code [1] 319145 0
Early detection / Screening
Intervention code [2] 319434 0
Prevention
Comparator / control treatment
Usual care group.
The Usual Care Group will be patients in general practices who are not in the OPC Clinical Audit Group. General practices recruiting patients to the Usual Care Group will be mutually exclusive to the OPC Clinical Audit practices. Patients in the Usual Care Group will be recruited based on the same Inclusion Criteria as those in the OPC Clinical Audit Group (both for high risk exacerbation and high risk undiagnosed COPD patients).
Patients in the Usual Care Group will be matched 1:1 to the patients in the OPC Clinical Audit Group based on demographics (gender, ethnicity, year of birth, suburb of residence), diagnoses, medication prescribed (including dose, repeats and quantity). Patients in the Usual Care Group will receive the OPC Clinical Audit at 12 months. It is not known what type of care these patients will have received prior to the OPC clinical audit. Usual care includes scheduled consultations with GP but no additional completion of questionnaires as per audit patients (respiratory function tests may occur within usual care depending on physician discretion).
Control group
Active

Outcomes
Primary outcome [1] 325809 0
The percentage of at-risk patients with an asthma-related (defined as asthma, mixed asthma/chronic obstructive pulmonary disease (COPD) and/or mixed asthma/respiratory infections) crisis event i.e. an Accident and Emergency attendance, hospitalisation or death, over 12 months. This data will be collected via patient completed questionnaire which is part of the OPC audit process.
Timepoint [1] 325809 0
12 months post intervention commencement.
Secondary outcome [1] 389202 0
Time to first asthma-related crisis event(s) (admission to hospital) for at-risk patients. Outcome will be assessed via reports in patient completed OPC Audit questionnaire at 12 months post intervention.
Timepoint [1] 389202 0
Will be assessed at 12 month post intervention commencement.
Secondary outcome [2] 389203 0
The percentage of all registered asthma patients with an asthma-related crisis event. This will be determined via patient completed OPC audit questionnaire.
Timepoint [2] 389203 0
12 months post commencement of intervention
Secondary outcome [3] 389204 0
The percentage of at-risk asthma patients with good symptom control. This outcome will be assessed as the percentage of at-risk asthma patients with good symptom control defined as answering ‘no’ to daytime symptoms >3 days/week, need for reliever use >3 days/week, night-time symptoms and limitations in daily activities.
Timepoint [3] 389204 0
10 months post intervention commencement
Secondary outcome [4] 389205 0
The percentage of at-risk and all registered asthma patients requiring a hospital admission. This will be measured via patient completed OPC audit questionnaire and general practice patient medical records.
Timepoint [4] 389205 0
12 months post intervention commencement.
Secondary outcome [5] 389206 0
The number of prescriptions of systemic corticosteroids for asthma attacks and antibiotic-treated lower respiratory tract infections (per patient per year) for at-risk asthma patients. This outcome will be assessed by review of general practice patient medical records.
Timepoint [5] 389206 0
12 months post intervention commencement.
Secondary outcome [6] 390294 0
The number of short-acting bronchodilator prescriptions issued (per patient per year) for at-risk asthma patients. This will be assessed via review of general practice patient medical records.
Timepoint [6] 390294 0
12 months post intervention commencement
Secondary outcome [7] 390296 0
The number of records of written personalised asthma action plans for at-risk asthma patients. Measured via general practice medical records and patient questionnaire. This questionnaire is a part of the audit process, it is called the OPC Audit questionnaire.
Timepoint [7] 390296 0
12 months post intervention commencement.
Secondary outcome [8] 390297 0
The number of inhaler technique assessments recorded for at-risk asthma patients. Measured via general practice patient record.
Timepoint [8] 390297 0
12 months post commencement of intervention
Secondary outcome [9] 390298 0
The number of smoking cessation advice or smoking cessation medications given (per patient per year) for at-risk asthma patients. Measured via general practice patient records.
Timepoint [9] 390298 0
12 months post intervention commencement
Secondary outcome [10] 390299 0
The number of flu vaccinations (per patient per year) for at-risk asthma patients. Measured via general practice patient records.
Timepoint [10] 390299 0
12 month post intervention
Secondary outcome [11] 390300 0
The number of ‘did not attends’ at primary and secondary care routine appointments (per patient per year) for at-risk asthma patients. Measured via general practice patient records.
Timepoint [11] 390300 0
12 months post intervention commencement
Secondary outcome [12] 395658 0
The number of records of patient self-monitoring with peak flow diaries (per patient per year) for at-risk asthma patients. Measured via general practice medical records and patient questionnaire. This questionnaire is a part of the audit process, it is called the OPC Audit questionnaire.
Timepoint [12] 395658 0
12 months post intervention commencement
Secondary outcome [13] 395659 0
The percentage of at-risk and all registered asthma patients dying for any reason. This will be measured via patient medical records.
Timepoint [13] 395659 0
12 months post intervention commencement

Eligibility
Key inclusion criteria
1. Patients with a COPD and/or asthma diagnosis at high risk of exacerbations who fulfil the following criteria :
• Have a recorded diagnosis of asthma and/or COPD,
• are aged 18 years and above and/or
• have had a spirometry performed (Spirometry Medicare Item Number – 11506), and/or
• have had a prescription for inhaled asthma and/or COPD medication issued within the last 12 months.
Patients with undiagnosed COPD and/or asthma at high risk of exacerbations who fulfil the following criteria, as reported in the previous 12 months:
• lower respiratory tract infection, (such as bronchitis, tracheitis and pneumonia, which might need antibiotic treatment),
• respiratory symptoms,
• consultations for lower respiratory symptoms with a course of antibiotics drugs or oral steroids prescribed on the same day and chest radiography.

No specific inclusion criteria for GPs.
Allocation to intervention and and control groups occurs at general practice level.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2488
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS

Funding & Sponsors
Funding source category [1] 307277 0
Commercial sector/Industry
Name [1] 307277 0
GSK Pty LTd
Country [1] 307277 0
Australia
Primary sponsor type
Other
Name
The Woolcock Institute of Medical Research
Address
431 Glebe Point Rd
Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 307910 0
Other
Name [1] 307910 0
Optimum Primary Care (OPC) Australia
Address [1] 307910 0
Unit 4a, 12 Abercrombie St, Rocklea
Brisbane, QLD 4106
Country [1] 307910 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308261 0
Bellberry Limited
Ethics committee address [1] 308261 0
Ethics committee country [1] 308261 0
Australia
Date submitted for ethics approval [1] 308261 0
30/05/2021
Approval date [1] 308261 0
Ethics approval number [1] 308261 0

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

Contacts
Principal investigator
Name 107006 0
Prof Sinthia Bosnic-Anticevich
Address 107006 0
The Woolcock Institute of Medical Research, 431 Glebe Point Rd Glebe NSW 2037
Country 107006 0
Australia
Phone 107006 0
+61 2 91140145
Fax 107006 0
Email 107006 0
sinthia.bosnic-anticevich@sydney.edu.au
Contact person for public queries
Name 107007 0
Sinthia Bosnic-Anticevich
Address 107007 0
The Woolcock Institute of Medical Research, 431 Glebe Point Rd Glebe NSW 2037
Country 107007 0
Australia
Phone 107007 0
+61 2 91140145
Fax 107007 0
Email 107007 0
sinthia.bosnic-anticevich@sydney.edu.au
Contact person for scientific queries
Name 107008 0
Sinthia Bosnic-Anticevich
Address 107008 0
The Woolcock Institute of Medical Research, 431 Glebe Point Rd Glebe NSW 2037
Country 107008 0
Australia
Phone 107008 0
+61 2 91140145
Fax 107008 0
Email 107008 0
sinthia.bosnic-anticevich@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.