PHASE 2 RANDOMISED CONTROLLED TRIAL OF FUTURE CARE PLANNING IN PATIENTS WITH ADVANCED HEART DISEASE

Introduction Patients with advanced heart disease typically have a poor prognosis despite optimal cardiac therapy. These patients and families rarely receive coordinated holistic assessment and future care planning (FCP). Aim(s) and method(s) This Marie Curie funded phase 2 trial seeks to explore whether a FCP intervention is acceptable, feasible and deliverable to patients (and families) with advanced heart disease following a recent unscheduled hospital admission. Patients with an unscheduled admission for acute coronary syndrome (ACS) or heart failure (HF) were screened using a prognostic scoring tool. Patients with a 12 month estimated mortality risk of 20% or greater were randomly allocated to either early (upon discharge) or delayed (after 12 weeks) FCP for 12 weeks. The FCP intervention combines holistic needs-assessment by a cardiologist with creation of a written/shared FCP and nurse-led care in the community. Primary outcome is quality of life of patients and carers assessed using questionnaires. Results We recruited 50 patients (32 carers) – 22% with ACS, 68% HF and 10% valvular heart disease. There were 5 deaths and 5 withdrawals. For the whole cohort mean age is 81.1 years (SD=8.6), 60% male, mean Charlson comorbidity index was 4.2 (SD=1.7), median Canadian frailty scale=5 (Mildly frail). Intervention and follow up is currently on-going. Conclusion(s) Findings demonstrate that the intervention and outcome measures were feasible and deliverable. Further analysis will provide invaluable information on the nature and feasibility of a larger clinical trial sufficiently powered to address hard clinical end-points.