Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease

Abstract

Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost. We assessed the feasibility, acceptability and tested a design of a randomised trial evaluating the impact of FCP in patients and carers. 50 patients hospitalised with acute heart failure or acute coronary syndrome and with predicted 12 month mortality risk of >20% were randomly allocated to FCP or usual care for 12 weeks upon discharge and then crossed-over for the next 12 weeks. Quality of life, symptoms and anxiety/distress were assessed by questionnaire. Hospitalisation and mortality events were documented for 6 months post-discharge. FCP increased implementation and documentation of key decisions linked to end-of-life care. FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94). Quality of life was unchanged (EQ5D: E 0.54(0.29) vs D 0.56(0.24), p = 0.86) while unadjusted hospitalised nights was lower (E 8.6 (15.3) vs D 11.8 (17.1), p = 0.01). Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians. FCP is feasible in a randomised clinical trial in patients with acute high risk cardiac conditions. A Phase 3 trial is needed urgently.

Figure 1. Flow chart of patients screened, excluded and recruited.

Patients over the age of 70 were routinely screened on cardiology and general medical wards using the GRACE and EFFECT scores; an estimated risk of death within 12 months of at least 20% was the threshold level for trial inclusion the reasons for failing to recruit eligible patients are also listed in the flow chart.

Figure 2. Change in Process Outcomes during the intervention for early and delayed groups.

Proportion (%) of patients in early and delayed arms of the trial with completion of each of the process measures included in the intervention which were discussed and documented in the written Future Care Plan at baseline, 12 and 24 weeks after discharge.