A trial to evaluate a best practice cardiogenic shock care pathway vs standard care on equity and patient outcomes in Cardiogenic Shock:

ESCAPE-CS is multicentre, two-phase prospective cohort study, to develop, deploy and assess a multifaceted system of care for cardiogenic shock, beginning at the time of referral. A total of 200 patients will take part in this study, 100 in Phase 1, and 100 in Phase 2, conducted in 7 or more Australian centres. Phase 1, a 12-month ‘usual care’ phase, is followed by Phase 2, a 12-month study intervention phase . The overall duration of involvement for participants is up to 6 months post-cardiac shock event. As yet there are no standardised protocols for identification and treatment of cardiogenic shock, nor guidelines regarding when to refer a patient with early stages of shock to a specialist centre. The study proposes the delivery of a multifaceted system of care for cardiogenic shock, beginning at the time of referral. The intervention has three components: a streamlined referral system; a multidisciplinary shock team; and protocol-driven care A streamlined referral system; The referral system will be modelled on the existing ECMO referral system (available from www.nsw-ecmo.net). Clinical data collected via this referral system will be entered into a Research Electronic Data Capture (REDCap ) database built by an expert team at the NHMRC CTC. Upon entering this data, the referring clinician will be provided with immediate automated feedback including shock severity. The referral will be fielded immediately by an on-call heart failure cardiologist. On-call responsibilities will be shared between the two quaternary study centres (St Vincent’s Hospital, Sydney and Royal Prince Alfred Hospital (RPAH), Sydney), with each centre responsible for fielding referrals from their ‘usual’ referring centres within the study. Confirmation that patient meets study inclusion/exclusion criteria will result in automatic activation of the multidisciplinary shock team A multidisciplinary shock team Quaternary referral centres will establish a shock team comprising an intensive care specialist, cardiac surgeon, heart failure cardiologist and interventional cardiologist. All shock team members participate in existing 24/7 on-call rosters, so availability should not be an issue. This team will be activated upon confirmation of CS by the on-call heart failure cardiologist from that quaternary centre. Upon activation, the team will convene, involving the referring clinician, to collectively determine investigations, management and need for transfer. Referrals to other centres via usual pathways, if appropriate, will be made by the shock team. Protocol-driven care. Clinical decisions will be made with reference to a standardised protocol guiding the use of invasive investigations and treatments, including the use of mechanical circulatory support devices. Key features of the proposed protocol include: i. Emphasis on using clinical and haemodynamic data to guide rational use of therapies; ii. Modular approach to treatment selection, based on local practice patterns, resources, availability and expertise, including choice of mechanical support devices and medications; and iii. Modular approach to referral, guided by patient needs and utilising established local referral pathways wherever appropriate. Transfer to a quaternary centre is considered when the capabilities of local referral centres and pathways are exceeded. There will potentially be two pathways for treatment - one for Acute Myocardial Infarction (AMI) and the other for Advanced Heart Failure. Both protocols will recommend treatment with the use of vital signs and treatment that is already part of standard care. These patients will be critically unwell and require 24-hour monitoring, including monitoring of blood pressure, ECG, inotropes infusing, and arterial blood gases. All patients admitted with cardiogenic shock would also receive an initial ultrasound imaging undertaken by an interventional cardiologist or doctors in ICU/ED accredited upon admission to the hospital. The treatment pathway provides guidance on when to transfer to a PCI centre for a right or left heart catheter and potential percutaneous coronary intervention to be done by an interventional cardiologist or if mechanical support is required eg IABP, VA ECMO. The pathway, is to be finalised based on the findings of Preliminary Phase end-user engagement. The primary clinical outcome is all-cause 30-day mortality. . The patient will complete the study at day 180 post index admission with the completion of quality of life questionaires. EQ5D and KCCQ12