The Breathlessness Rapid Evaluation And THErapy study (BREATHE)

Background:

About 1 in 10 adults have breathlessness, totalling over 1.8 million in Australia alone.

Breathlessness (dyspnoea) is a common presenting complaint in primary care and is a symptom of cardiovascular and respiratory disease, but also associated with obesity, loss of fitness and anxiety.

Breathlessness that chronically limits exertion significantly reduces quality of life and is becoming more prevalent following bushfires, consequent worsening air pollution and severe SARS-CoV-2 pandemic. 

Respiratory conditions account for around 10% of deaths in Australia and 31% of Australian adults have a chronic respiratory disease. There is a significant need to improve health outcomes in respiratory space, however the multifactorial nature of breathlessness challenges general practitioners’ ability to provide correct diagnosis or best management. 

In a recent survey of over 10,000 Australian adults, 22% reported a current respiratory or heart condition or both. Of those with a current respiratory condition, 38% were not taking medications for any breathing or lung problem and 41% of those reporting a current heart condition were not taking cardiac medications, even though a quarter of these had breathlessness limiting daily activity.

Respiratory systems are poorly investigated and sub-optimally managed at present, thus a more consistent approach to screening of dyspnoea and effective diagnosis is needed to result in better health outcomes. 

BREATHE is an innovative digital technology that fully automates patient screening and a data driven clinical algorithm to aid the diagnosis and management of breathlessness integrated in the primary care electronic health record and will be the first of its kind globally.

Aim:

The overall aim of the BREATHE study is to develop and test an automated system that identifies at-risk patients with breathlessness (BREATHE SMART) and integrates a clinical decision support system (BREATHE CDSS) in the electronic health record to better identify and manage patients with breathlessness in primary care.

A priority of the 2019 United Nations Sustainable Development Goals was to strengthen Primary Health Care through the development of health information systems and digital technologies. However, research on effective and applicable approaches to strengthen primary care using digital health and clinical AI remains scarce. Many interventions in general practice fail to bring about any real changes in patients’ health, as their implementation contributes to worsening time pressures for practitioners and is burdensome on practice staff. Our proposed study directly addresses this key objective by empowering the GP clinics to reduce the time to diagnosis and effective treatment, as well as assist with prioritising the most appropriate diagnostic tests, thus reducing costs and clinical waste.

Research Methodology:

The pragmatic implementation trial will be a cluster randomised controlled 2-arm trial in 40 primary care sites. Each arm will comprise of 20 practices, and are outlined below:

• Arm 1: BREATHE SMART intervention and standard of care management. 
• Arm 2: BREATHE SMART and BREATHE CDSS interventions.

Practices will be recruited from urban and rural areas. The intervention will run for 12 months in each practice, it is estimated that around 300 patients per practice (based on an average practice size) will undertake the self-screening intervention (i.e. an estimated 12,000 patients across the 40 practices with the BREATHE SMART intervention).

For the BREATHE CDSS, 400 participants are required to participate (200 per arm) which means a target for each practice to recruit a minimum of 10 participants, who will be followed up for 12 months. We will aim for an even balance of sex, age distribution and urban, regional, and rural participants.

Current Status

Start up activities commenced.