RECAP - A real life implementation study on management of chronic obstructive pulmonary disease (COPD) and high risk asthma in general practice.

This project focuses on preventing high cost/high burden respiratory events through the harnessing, coordination, dissemination and scaling up of an evidence-based clinical audit model (OPC Clinical Audit) into general practice. It utilises technology, digital health (including patient report outcomes) and clinical decision support systems (CDSS) to support upscaling. It aligns with national strategies for quality improvement in general practice, hence utilised current general practice infrastructure. This study will take the form of a parallel, repeated measure, real-world study design in which patients at risk will be compared between the OPC Clinical Audit Group or the Usual Care Group (see below). The study period for each patient enrolled will be 12 months. Practices and thus patients will be recruited into one of two groups: The OPC Clinical Audit Group or the Usual Care Group. While data collection for the OPC Clinical Audit Group will be prospective for 12 months, data collection for the Usual Care Group will occur at 12 months and be retrospective. The OPC Clinical Audit consists of the following 2-staged processes: 1. The secure and confidential extraction of data from all patients with asthma and/or COPD from the practice, including a screen for undiagnosed COPD 2. The collection of patient-reported outcomes as per the evidence-based Patient Questionnaire. From these processes a list of patients at high risk of exacerbations/undiagnosed COPD will be automatically generated. 3. Face-to-face review of high-risk patients (identified above) with the practice nurse, followed up with a consultation with the GP utilising clinical decision support advice from OPC. These processes are discussed in further detail below. Data Extraction: Two data screening and extraction processes from electronic medical records will be carried out in parallel: high-risk exacerbation and high risk undiagnosed COPD patients will be identified using data screening and extraction with reference to the key inclusion criteria of this study. The following patient information will be extracted from primary care records: 1. demographics (gender, ethnicity, year of birth, suburb of residence), 2. medication prescribed (including dose, repeats and quantity), 3. diagnoses, consultations (including reasons, 4. type of provider e.g. doctor or nurse), pathology tests (ordered and results), 5. imaging test (orders and results), 6. referrals to a specialist (or other health care providers), 7. patient assessments and management (e.g. asthma plans, GP Management Plans, etc), 8. medical history (previous diagnoses and medicines), 9. health information (health weight, blood pressure, smoking status). Patient Questionnaires: Validated questionnaires which collect data relating to the patient’s respiratory clinical status, smoking status, allergic rhinitis status, medication use, side effects, medication use, medication beliefs and adherence will be collected. These will be distributed to patients through an automated process; the general practice will dispatch electronic questionnaires via email to all respiratory patients (as per inclusion criteria). Patients will complete the questionnaires online. Data collected from the extraction process and patient questionnaires will be combined by OPC Australia through an automated, algorithm, which based on current COPD and asthma management guidelines for the identification of high risk patients and evidence for the identification of patients with undiagnosed COPD from general practice records. The respiratory risk algorithm, will generate a report which identified patients at high risk of respiratory exacerbations and high risk of undiagnosed COPD. Identified patients will be contacted by the practice and invited to have attend the general practice for respiratory review. Face-to-face respiratory review: The practice nurse will conduct the first phase of the respiratory review. It is anticipated that the face to face respiratory review with the practice nurse will take 30 minutes. Practice nurses will collect additional data to complement that data extracted from medical records and collected through patient questionnaires. Addition data will include: oral and intranasal inhaler administration technique, fractional exhaled nitric oxide (FeNO) and spirometry including inspiratory flow rate. Patient data collected from the face-to-face respiratory review will be recorded in the patient’s electronic health record and automatically added to the respiratory risk algorithm in order to determine a list of recommendations for management. These recommendations will provided to the GP, in order for him/her to determine any management decisions (or in terms of COPD diagnosis, to be able to make a diagnostic decision) for each individual patients. These recommendations are aligned with the objectives and management principles outlined in the National Asthma Strategy 2018 and the National Strategic Action Plan for Lung Conditions 2018; they are underpinned by the management principles outlined in the National Asthma Management Guidelines (2018) and the Australian and New Zealand Guidelines for the management of COPD (COPD-A X Plan). A consultation with the GP in which recommendations will be discussed by the GP with the patient will follow the completion of their face-to-face respiratory review. The recommendations presented will enable the delivery of a high quality, precision medicine approach to the management. Patients who receive the OPC Clinical Audit will be followed up in 12 months, with a second OPC Clinical Audit, at which time the same 2-staged process will be implemented. This means that the OPC Clinical Audit is both a clinical management tool and an evaluation tool, which can monitor patient outcomes and impact of the audit over time. General practices will be assigned to either the OPC Clinical Audit Group or the Usual Care Group. OPC Clinical Audit Group and Usual Care Group will be geographically separated and mutually exclusive.