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

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.