A primary care multi-disciplinary team care approach, including pulmonary rehabilitation, to address uptake and outcomes of comprehensive evidence-based care for Chronic Obstructive Pulmonary Disease (COPD) (MDT-PuRe-Primary Care).

The aim of this two by two factorial design trial is to evaluate the implementation, effectiveness, and cost-effectiveness of two new healthcare strategies (services) to improve the provision of evidence-based management for people with COPD compared with usual GP management of COPD. The two new strategies are to: 1) Upskill registered nurses to provide Multi-Disciplinary Team (MDT) care planning with the General Practitioner (GP) for people with COPD 2) Provide access to an 8-week PUlmonary REhabilitation program in Primary Care (PuRe Primary Care) delivered by private Exercise Physiologists (EPs) or Physiotherapists (PTs) in the community. Patients will be randomised to one of four groups which include combinations of the two implementation strategies. Arm 1: MDT Care (Strategy 1) & PuRe Primary Care (Strategy 2) Arm 2: MDT Care (Strategy 1) & Usual PR (Control Strategy 2) Arm 3: Usual GP Care (Control Strategy 1) & PuRe Primary Care (Strategy 2) Arm 4: Usual GP Care (Control Strategy 1) & Usual PR (Control Strategy 2) Strategy 1: MDT Care delivered by a General Practice Nurse (GPN), Nurse Practitioner (NP) or Aboriginal Health Worker (AHW), as determined by the participating health services. The GPN/NP/AHW will conduct a tailored, multi-component self-management program. The GPN/NP/AHW will work with the patient to systematically address patients’ beliefs, perceived benefits of action and barriers to action, self-efficacy (engagement or lack of engagement) and use stimuli (cues to action) to trigger COPD self-management behaviours. The program will be tailored based on patients’ individual demographics, priorities and motivation to ensure that the level of support provided is appropriate to the needs of the participants and engagement in change will be supported using motivational interviewing. The GPN/NP/AHW will deliver the intervention through an initial assessment visit (virtual or face to face) followed by two health coaching sessions (about 45 minutes each) spaced four weeks apart. Following the last session, PNs will provide a summary of the program for the patient and their GP. This is adapted from ACTRN12622000568718. The patients will attend three visits a month apart. The first visit will be virtual with options for face-to-face in one if preferred, and subsequent visits will be virtual. This strategy has been developed and successfully tested by members of the research team. The first visit will involve developing an individualised COPD plan. Prominent focus topics for said plan include understanding the COPD diagnosis and diseases process, managing COPD symptoms and flare-ups, and long term management of health conditions. In subsequent visits, the GPN/NP/AHW will assess compliance with the plan and provide supportive strategies including motivational intervewing. Session adherence will be collected by the nurse and provided to the research team. No other adherence data will be collected. At the end of the intervention with the GPN, a report based on a care plan will be sent to the GP detailing the care provided. If the GPN / GP prefer, they can also include a verbal handover. Each visit will take approximately 45-60 minutes to complete. Strategy 2: PuRe Primary Care, patients will be provided with a referral to the Pulmonary Rehabilitation (PR) program provided in primary care in their local area from the research assistant and an appointment booked for the initial assessment. The PR program has been developed from the recommendations from the outcome of the Medical Services Advisory Committee (MSAC) application and is currently being piloted by a PhD student (ACTRN12622001501730). The PR program consists of: 1. An initial assessment which includes an assessment of blood pressure pre and post the exercise capacity test. The exercise capacity test will be either an incremental shuttle walk test (ISWT) and a one sit to stand testfollowing standard protocols. The choice of test will be determined by the space available in the EP/PT practice. The assessment will take approximately 30 minutes. Preliminary data from the pilot PhD project indicate that the ISWT is most frequently used as it requires a smaller space. Prior to conducting an exercise test or exercise session, each participant will have a subjective assessment performed and have baseline observations of blood pressure, heart rate and oxygen saturation conducted. Any contra-indications to exercise will mean that the exercise test or session will not proceed, and the participant will be referred for medical review by their GP as appropriate. 2. The assessor or clinician delivering the intervention will monitor all participants throughout the assessments and intervention exercise sessions. If a participant experiences an adverse event while undertaking any study-related procedures, the safety procedure will be followed at all times and the adverse event documented. During the assessments, patients will be monitored with blood pressure, blood oxygen, and heart rate pre, during and post testing, as well as pre, during and post exercise. Patients will be continually monitored by the clinician by Borg scale to assess breathlessness and fatigue. 3. The PR program will consist of three exercise sessions (one at home) per week for 8-weeks prescribed by private practice EPs/PTs. The exercise program will include endurance exercises and upper/lower limb functional strength exercises prescribed at an appropriate intensity based on a baseline incremental shuttle walk test (ISWT) and will be progressed accordingly during the PR program. Exercise selection will also be determined by the equipment available at the practice. Examples of exercises include treadmill or ground walking, stationary cycling, as well upper and lower limb strengthening exercises using resistance bands or free weights. The exercise sessions will take approximately 1 hour. 4. Patient education will use COPD Online Patient Education (C.O.P.E) https://cope.lungfoundation.com.au/ developed by LFA and/or the education videos developed within the ‘mobile pulmonary rehabilitation program’ (m-PR). C.O.P.E. uses short videos, and interactive sections to lead the patient through several modules, including; Understanding your lungs and COPD, Managing your medicine and symptoms, How you can better help yourself, Physical activity and exercise, and Living with a lung disease. The program finishes with a post-program knowledge questionnaire. Patients will be instructed to complete the education program. 5. There is an additional option for participants to complete the program virtually via Perx m-PR (or a hybrid of face-to-face and m-PR) depending on location and patient preference. The m-PR program has been developed by the researchers and is being tested in a randomised controlled trial in Northern Sydney LHD. If the patient chooses to use the m-PR, their EP/PT will upload their personalised exercise program into the app through the clinician portal. Patients will be able to record their exercise progress in the m-PR app which will be visible to their treating EP/PT. The m-PR clinician portal allows the physical therapist to track each participant’s progress and individualize the participant’s exercise and education program, 6. Maintenance exercise is beyond the scope of this intervention, however clinicians will refer to local maintenance options after completing the PR program, as this is what evidence-based practice encourages. Uptake in maintenance exercise will be encouraged through: i) Lungs in Action; ii) m-PR maintenance; or iii) home exercise prescription.