Targeting Treatable Traits (TTs) in Chronic Obstructive Pulmonary Disease (COPD) to Prevent Hospitalisations.

Intervention (TERRACOTTA) participants will undergo a multidimensional assessment at baseline with the practice nurse to characterise TTs across pulmonary, extra-pulmonary, and behavioural/risk factor domains. A case management meeting will then be organised between the practice nurse and participant to plan the delivery of the intervention. The intervention will comprise: 1. mHealth: A specifically designed application installed on the personal mobile phone to record symptoms and medication usage on a weekly basis will be used by the participants for 12 months. Participants will also be prompted to follow an individualized written action plan specifically developed by the study team. The CSIRO AHERC has designed similar innovative mHealth solutions for optimising care delivery for individuals with chronic diseases, which will be utilised in this trial. Each participant will have their own profile compiled through the portal, to ensure that the app is tailored and individualised according to their specific needs. An automated feedback message will be sent weekly according to an algorithm based on guidelines. An automated weekly message of overall COPD control will be displayed as ‘well-controlled’ (green zone), or ‘not well controlled’ (yellow or orange zone) or ‘very poorly controlled’ (red zone), to encourage participants to follow their agreed written action plan. All data will be transmitted automatically to a central server of CSIRO to which participants and their health professionals have secure access. 2. Home-based pulmonary rehabilitation (HomeBase): This rehabilitation program involves 8 weeks of individually prescribed exercise training and self-management education delivered by a physiotherapist. The model includes one home visit (approximately 2 hours) by the physiotherapist, followed by weekly follow-up telephone calls using a motivational interviewing approach to build confidence and set goals. Home based exercise training is prescribed based on each patient’s exercise capacity, walking distance is assessed using pedometers and participants record their daily walking in a diary or mHealth app. Participants will be encouraged to exercise for 30 minutes, five times per week. Exercise intensity is symptom guided, with a target of moderate to somewhat severe dyspnoea rated on the Borg scale. Strength training utilizes activities that can easily be performed at home, such as stair training and sitting to standing from a chair. Participants will be telephoned weekly by the physiotherapist to (1) review the home diary/mHealth app; (2) progress the exercise prescription; and (3) for self-management education. Self-management training will include managing acute exacerbations; monitoring exercise; managing breathlessness; and accessing community supports. On completion of the program, participants will be encouraged to continue with external peer support and social group for people with COPD (e.g. LFA’s Lungs in Action program). 3. Home Medication Review (HMR): A comprehensive HMR from a consultant pharmacist will identify any medication-related problems and deviations from COPD-X. The pharmacist will visit patients at their home (a single 1.5 hour visit), assess medication adherence and inhaler techniques, educate visually and verbally (with the help of infographics available from Lung Foundation Australia/NPS Medicinewise and educational materials developed specifically for the study) on role of medications in management of COPD, management of comorbidities and behavioural risk factors (e.g. smoking, non-adherence) and recommend strategies for improving medication use (e.g. developing routines, using reminders). A written report will be sent to the practice nurse and GP. A case conference will be organised after one month among the pharmacist, the GP and the practice nurse, to review the recommendations and changes in management. 4. Written action plan: The practice nurse and GP will work with each participant (face-to-face for 30 minutes) to design a written action plan consistent with COPDX guidelines based on information obtained at baseline. It will contain instructions on which medications to take when feeling well, how to recognise worsening disease using peak-flow meters/portable electronic micro-spirometers and/or symptoms, what to do when symptoms are getting worse and in the event of an acute exacerbation, a first aid plan. Where appropriate, each participant’s GP will also give a script for oral steroids/antibiotics, which can be initiated after discussion with the practice nurse, who will assess the need based on symptoms and/or lung function. 5. Smoking cessation support: The practice nurse will coordinate individualised intensive smoking cessation support (duration ~15 minutes) comprising pharmacotherapy and behavioural support to all current smokers based on the RACGP guidelines. The intervention(s) offered will be individually tailored to the patient’s smoking status, needs and preferences. If prescription medications (e.g. varenicline) are required to assist quitting, these will be discussed with the participant’s GP. Smoking cessation support is offered at an initial consultation, with follow-up phone calls at 1 week and 1 month from the initial consultation, as appropriate. 6. Referrals to other professionals: Additional evidence-based risk reduction referrals (e.g. dietitian, sleep clinic) will be made by the practice nurse in consultation with the GP. The intervention model of care will be coordinated by the practice nurse at each clinic under the supervision of each participant’s GP. Following real-world practice, consenting patients will be referred by the GP, at their discretion, to HomeBase and HMR. The written action plan will be implemented subsequent to HMR, but the order of HMR and HomeBase is dependent on patient and provider availability/convenience.