IMplementation and Prospective evAluation of dedicated Cardio-oncology services for prevention, monitoring and Treatment of CardioVascular Diseases in patients living with, through and beyond CANCER (IMPACT-CVD in CANCER trial)

The intervention and implementation strategies will be delivered sequentially at 3 sites at 3-monthly intervals, after a prospective pre-intervention period of 8 months at the first site. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Following the baseline data collection (pre-intervention) period, each site will receive a systems-based intervention. A nurse-led, physician-supported cardio-oncology risk stratification clinic designed to meet the key evidence-based recommendations of the first international cardio-oncology guidelines will be implemented. The clinic, integrated with cancer services, will be focused on guideline-directed: a) baseline preventable cancer and cardiovascular risk assessment and management; and b) appropriate cancer and cardiovascular risk surveillance during and after cancer treatment. The components and frequency of ongoing surveillance will depend on the patient’s baseline risk assessment, as per guidelines. All follow-up visits will be conducted as per recommendations in the cardio-oncology guidelines. The following will be undertaken: Referral to cardio-oncology clinic: Eligible patients will be identified utilising electronic health records by nurses based on the published guidelines. Patients will be pre-screened, and those identified as at medium or moderate cardiovascular toxicity risk will receive a referral letter to the cardio-oncology clinic. Patients are then provided with a clinic appointment (within 3-4 weeks of initial referral). At the first clinic appointment, the nurse will complete the following patient screening: Baseline Cardiovascular Risk Assessment: Baseline cardiovascular risk assessment and management will consist of determining the risk of cardiovascular complications of anti-cancer therapy as per guidelines and allows appropriate surveillance planning. The HFA-ICOS risk assessment tool will be used to assess risk in patients with cancer scheduled to receive cardiotoxic anticancer therapy. A standardized approach for all patients will include a focus on the management of shared cancer and cardiovascular risk factors: hypertension, dyslipidaemia, hyperglycaemia, smoking, alcohol consumption, poor diet, and exercise; and the prescription of cardiovascular medications (by the supporting physician). The nurse-led cardio-oncology clinic focusses on cardiovascular risk stratification, management, education as well as lifestyle, pharmacological and non-pharmacological interventions This will include individualized, patient-centred assessments of risk factors for prevention and early the provision of education and support towards making positive lifestyle changes that reduce the risk of CVD in cancer patients longer term. Management of risk factors will be undertaken according to the European Society of Cardiology (ESC) guidelines on cardiovascular disease prevention in clinical practice. For example, it is recommended treatment goals for risk factors be achieved in a stepwise approach, with the first step being to achieve recommended goals for blood pressure and cholesterol levels through lifestyle recommendations and medication if needed. Blood pressure will be measured at each clinic appointment. All medication prescriptions will be protocol driven, derived from the current Australian cancer and cardiovascular guidelines. The supporting physician will assess patients either face-to-face or via telehealth if required. This involves a time estimation of 1 hour for baseline assessment, and 30 – 45 minutes follow-up appointment at 6 months and/or 12 months. The components and frequency of ongoing surveillance will depend on the baseline risk assessment, as per guidelines. All follow-up visits will be conducted as per recommendations in the cardio-oncology recommendations. For example, the international position statement on cardiovascular assessment for people with cancer, (from the the Heart Failure Association of the European Society of Cardiology Cardio-Oncology Study Group in collaboration with the International Cardio-Oncology Society) describes that the timing and nature of CV surveillance recommendations depends upon several factors including the cardiotoxicity profile of the cancer therapy, the risk factors contributing to the risk level calculation and patient preference. However, all patients are recommended a 6-month and/or 12-month follow-up clinic appointment. Their GP is also provided a summary of their care. Implementation strategies Evidence-based (Cochrane-EPOC) implementation strategies will provide support for implementation of the IMPACT-CVD in CANCER intervention at each site. These include: 1. Local clinical guidelines: Specific for cardio-oncology care outlining the steps to undertake the intervention will be provided to staff. This will be provided in the form of a manual that will be provided to all relevant staff. This will describe the required tasks, including assessment and referral of patients to clinics and the intervention care elements. This document will be provided to all relevant staff via email. 2. Staff education and training: A training package, including online and face-to-face training addressing referral to the clinic and the intervention care elements; case studies. The research team will provide training to all applicable staff (approximately 3 hours training) 2 weeks before the start of the intervention. This will incorporate a shared care model between cardiology and oncology with multidisciplinary case presentations, consistent updated cardio-oncology seminars given to oncology and hematology departments; executive support with implementation of clinic, and referral infrastructure is embedded in care processes. Clinician education materials and activities for clinical staff of oncology and haematology departments will include evidence of need (toxicities), cardiovascular treatment effectiveness, benefits of such treatment for continuation of cancer treatment and patient benefits (both cancer and cardiovascular); and implementation of feedback from cardiovascular clinic to treating cancer. 3. Systems support: Modification to existing clinical prompts/medical record/referral and discharge systems/processes to facilitate referral to the clinic and delivery of the intervention. 4. Audit and feedback: Clinic performance reports of care delivery and outcomes will be monitored in monthly clinic team meetings. Site-specific feedback reports will be emailed to the project advisory group, including the local relevant staff at each site (e.g. oncologist, nurses), each month, for the duration of the intervention. The regular feedback will serve as a reminder and the feedback report will also include education, with links to applicable sections of the relevant guidelines serving as reminders, and summaries of evidence for the baseline CV risk assessment. 5. Prompts/reminders: Will be used to provide point of care guidance to clinicians regarding model of care elements (e.g. prompt cards; ward flow, clinician communication). 6. Consumer resources package: Patients will also receive a package of existing resources including ESC Clinical Practice Guidelines for patients.