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Trial registered on ANZCTR


Registration number
ACTRN12624001451594
Ethics application status
Approved
Date submitted
2/10/2024
Date registered
13/12/2024
Date last updated
13/12/2024
Date data sharing statement initially provided
13/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Breathlessness Rapid Evaluation and Therapy Study Clinical decision support system (BREATHE CDSS): The effect of a clinical decision support tool for shortness of breath on disease control and symptoms
Scientific title
The Breathlessness Rapid Evaluation and Therapy Study Clinical decision support system (BREATHE CDSS): The effect of a clinical decision support tool on control and symptoms in adults with dyspnoea
Secondary ID [1] 313034 0
None
Universal Trial Number (UTN)
Trial acronym
BREATHE CDSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with breathlessness 335253 0
Dyspnoea 335740 0
Chronic Dyspnoea 335741 0
Condition category
Condition code
Respiratory 331813 331813 0 0
Asthma
Respiratory 331814 331814 0 0
Chronic obstructive pulmonary disease
Respiratory 331815 331815 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BREATHE (Breathlessness Rapid Evaluation And THErapy) study will develop and test an automated system that identifies at-risk patients, conducts screening of patients’ with dyspnea via their phones or electronic devices, and automatically integrates these results into an electronic CDSS to provide recommendations to the GP for diagnosis and management

BREATHE CDSS (Breathlessness Rapid Evaluation And THErapy- Clinical Decision Support System)

BREATHE CDSS is an innovative digital technology in which a clinical algorithm for the diagnosis and management of dyspnea is embedded.

Each arm will comprise of 20 practices, and are outlined below:
1. Arm 1: standard of care management
2. Arm 2: BREATHE CDSS guided management

Participants will complete a questionnaire on breathlessness at screening visit and this will identify if they are eligible to be included in the study based on having chronic breathlessness. This willl be completed on their own mobile phone. This will then prompt the GP via the CDSS during the consultation whether the participant is to be included in the study or not. Interaction with CDSS is only ever by the GP and not by the participant. Participants will answer questions based on what the GP thinks the underlying cause of the dyspnoea , documenting their primary diagnosis and seeing patients to assess any change in their breathlessness (improvement, no change or worse) at 3, 6 and 12 months. Patients can also see their GP whenever required in between these visits. All all visits the GPs are asked to use CDSS for patients in the CDSS, this includes study visits and any visits that happen outside of these study visits at 3,6, and 12 months. Even i f a primary diagnosis is made before 12 months, CDSS will continue to be administered at all visits until the participant reaches the 12 month visit.

Patients will complete online brief questionnaires at 3, 6 and 12 months to objectively document these changes. All visits will be conducted in person at the GP practice and GPs will be trained by the sponsor on using the CDSS, but it is in conjunction with using clinical diagnosis, and does not replace the need for clinical judgement. The CDSS will aid the GP in making the diagnosis and conducting assessments based on the most likely primary diagnosis. Training with all GPs in the GP practices will be done on all component of the CDSS by the sponsor as part of the site initiation visit, which will be face to face. 2-3 members of the project team will conduct these face to face. It is anticipated this will take an hour to conduct with all GPs in the practice who are involved in the study. Further face to face or virtual training sessions can be delivered at the request of the GP practice and when new GPs commence at the practice.

At Baseline GPs will interact with eligibility confirmation, demographics, medical history, smoking history, blood pressure, heart rate and weight. Questionnaires including mMRC, dyspnoea-12, PHQ4, EQ-5D-5L and VAS. GPs will interact on CDSS pages around hospitalisations, ED presentations, referrals and tests conducted, physical examination if conducted, current medications and new diagnoses.

At the 3, 6 and 12 month follow up visits GPs will interact with the following components of the CDSS - blood pressure, heart rate and weight. Questionnaires including mMRC, dyspnoea-12, PHQ4, EQ-5D-5L and VAS. GPs will interact on CDSS pages around hospitalisations, ED presentations, referrals and tests conducted, physical examination if conducted, current medications and new diagnoses.
Intervention code [1] 329581 0
Diagnosis / Prognosis
Intervention code [2] 329582 0
Early detection / Screening
Comparator / control treatment
Comparator arm is patients who are receiving standard of care in GP practices who are not assigned to CDSS and are followed up at 3,6,12 months with the same questionnaires but clinical management will not utilise the CDSS.

Standard of care is all patients who have breathlessness for 4 weeks or more at the GP practices who are assigned to the arm that does not receive CDSS.
Control group
Active

Outcomes
Primary outcome [1] 339446 0
Change in dyspnea measured by Dyspnea-12 (D-12) score at 3, 6 and 12 months.
Timepoint [1] 339446 0
Participants and primary outcomes will be assesses at Baseline, 3, 6, 12 months post enrolment.
Secondary outcome [1] 440024 0
Proportion of participants reaching disease control
Timepoint [1] 440024 0
Baseline, 12 months post-enrolment
Secondary outcome [2] 440025 0
Mean change in Dyspnea score (VAS) at 3, 6 and 12 months.
Timepoint [2] 440025 0
baseline 3, 6 and 12 months post enrolment
Secondary outcome [3] 440026 0
Time to final diagnosis.
Timepoint [3] 440026 0
baseline 3, 6 and 12 months post enrolment
Secondary outcome [4] 440027 0
Severity of dyspnoea
Timepoint [4] 440027 0
baseline 3, 6 and 12 months post enrolment
Secondary outcome [5] 440028 0
Change in Quality of Life
Timepoint [5] 440028 0
baseline 3, 6 and 12 months post enrolment
Secondary outcome [6] 440029 0
Composite endpoint of number of hospitalisations and emergency department presentations
Timepoint [6] 440029 0
12 months post enrolment
Secondary outcome [7] 441706 0
Proportion of breathless participants receiving a final diagnosis and evidence-based treatment at study end,
Timepoint [7] 441706 0
12 months post enrolment
Secondary outcome [8] 441707 0
proportion of care providers adopting CDSS features - this will be a proportion of care providers who have adopted all CDSS features
Timepoint [8] 441707 0
time of study closure at each site
Secondary outcome [9] 441708 0
proportion of GPs implementing and maintaining sustained use of the CDSS over 12 months
Timepoint [9] 441708 0
number of GPs who have used CDSS monthly
Secondary outcome [10] 441711 0
number OF investigations undertaken to reach a final diagnosis,
Timepoint [10] 441711 0
Baseline, 3, 6, 12 months post enrolment
Secondary outcome [11] 441712 0
number OF Specialist referrals for each participant,
Timepoint [11] 441712 0
Baseline, 3, 6, 12 months post enrolment
Secondary outcome [12] 441713 0
health economics evaluation - cost effectiveness of BREATH CDSS over usual care
Timepoint [12] 441713 0
12 months post enrolment
Secondary outcome [13] 442017 0
Proportion of participants reaching clinically important improvement
Timepoint [13] 442017 0
3, 6 and 12 months post enrollment

Eligibility
Key inclusion criteria
General Practice
1. Use BetterConsult software
2. Provide written informed consent to participate
3. Willing to recruit a minimum 10 participants per practice to the trial.
4. Agreement to enrol participants at their first visit and conduct follow-up according to the study protocol for the next 12 months.


Participant eligibility
1. Aged 18 years or older
2. Consent to SMS communication with their GP practice
3. Completion of the BREATHE SMART pre-screening questions
4. Presenting with/reporting dyspnea (lasting greater than or equal to 4 weeks)- the patient’s treating GP will have discretion around whether to activate the CDSS for each patient, as there may be some circumstances (e.g. end of life, cognitive impairment) where patients may not be suitable.
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
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will remain blinded from the study team and the allocation once applied will be known to both the GP practice and the research team. GP practices will be randomised to one of the two study arms. We will stratify by regionality (3 groups – urban, regional, remote) and ensure a 50:50 balance of the two arms within each of 3 regionalities. The GP practices will be enrolled over time, so we will create a schedule within each regionality using randomly permuted blocks (a mix of size 2 or 4) to ensure balance and would allocate as sites are activated. The research team will contact the TGI statistician to request the next allocation in the corresponding stratum
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
his BREATHE CDSS study is part of a cluster randomised controlled study (BREATHE) where clusters are randomised to arm 1 (BREATHE SMART - registered separately) or arm 2 (BREATHE CDSS - registered in this form). This arm (BREATHE CDSS) includes a comparison between the CDSS tool compared to usual care
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
5/01/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS

Funding & Sponsors
Funding source category [1] 317475 0
Government body
Name [1] 317475 0
National Health & Medical Research Council of Australia (NHMRC) 2021 MRFF Chronic Respiratory Conditions Grant
Country [1] 317475 0
Australia
Funding source category [2] 317476 0
Government body
Name [2] 317476 0
National Health & Medical Research Council of Australia (NHMRC) 2023 MRFF Clinician Researchers – Applied Research in Health Grant
Country [2] 317476 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health Australia
Address
Country
Australia
Secondary sponsor category [1] 320098 0
None
Name [1] 320098 0
Address [1] 320098 0
Country [1] 320098 0
Other collaborator category [1] 283291 0
University
Name [1] 283291 0
University of Notre Dame
Address [1] 283291 0
Country [1] 283291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316190 0
The University of New South Wales - Committee B
Ethics committee address [1] 316190 0
Ethics committee country [1] 316190 0
Australia
Date submitted for ethics approval [1] 316190 0
27/05/2024
Approval date [1] 316190 0
02/10/2024
Ethics approval number [1] 316190 0
iRECS6645

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

Contacts
Principal investigator
Name 137078 0
Prof Christine Jenkins
Address 137078 0
The George Institute for Global Health Level 18, International Towers 3, 300 Barangaroo Avenue, Barangaroo, NSW, 2000
Country 137078 0
Australia
Phone 137078 0
+61280524300
Fax 137078 0
Email 137078 0
cjenkins@georgeinstitute.org.au
Contact person for public queries
Name 137079 0
Dr Allison Humphries
Address 137079 0
The George Institute for Global Health Level 18, International Towers 3, 300 Barangaroo Avenue, Barangaroo, NSW, 2000
Country 137079 0
Australia
Phone 137079 0
+61280524300
Fax 137079 0
Email 137079 0
ahumphries@georgeinstitute.org.au
Contact person for scientific queries
Name 137080 0
Christine Jenkins
Address 137080 0
The George Institute for Global Health Level 18, International Towers 3, 300 Barangaroo Avenue, Barangaroo, NSW, 2000
Country 137080 0
Australia
Phone 137080 0
+61280524300
Fax 137080 0
Email 137080 0
cjenkins@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made publicly available for this trial. Deidentified data will be obtained only from trial sites for data analysis, but this will be maintained within the study team and not make available publicly


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.