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.

The Effect of Advance Care Planning on Heart Failure: a Systematic Review and Meta-analysis

“…While most patients in the meta-analysis suffered from heart failure class III or IVof the New York Heart Association, ACP was initiated at different time points: during an admission to hospital, 58 after a recent hospitalization, 55 after a deterioration in the patient's health status 52 or before a routine clinic appointment with a cardiologist. 53 These findings on the timing of ACP agree with the published literature which cites a change or deterioration in the patient's condition, a routine clinical review or a change in a patient's personal circumstances such as moving into a care home as possible triggers for ACP. 13 Control patients tended to receive only usual medical practice but no ACP unless it was specifically requested.…”

“…67,68 A lack of consideration of ethnic preferences, missing follow-up and the exclusion of family members may well have contributed to the low effect of their ACP intervention. The low effect size for ACP in the study by Denvir et al 53 was mainly due to the study design, i.e. a feasibility RCT.…”

“…Ten of the 14 studies were conducted in the USA, one in the UK, 53 , one in Australia, 54 one in Sweden 50 and one in Hong Kong. 61 The median sample size was 209 people (range 27 to 517 participants).…”

Frailty assessment and risk prediction by GRACE score in older patients with acute myocardial infarction

“…Patients aged ≥65 years old were assessed prospectively within the screening registry of a phase II randomized controlled trial of future care planning in advanced heart disease at the Royal Infirmary of Edinburgh between October 2013 and September 2014 (NCT 02302014) [16]. Patients with moderate/severe dementia or other barriers to informed consent were excluded.…”

Advanced heart failure: an appraisal of the potential of levosimendan in this end-stage scenario and some related ethical considerations

“…From a care delivery perspective, however, it is already clear that in heart failure, as in other conditions, delivery of end-of-life care is a multidisciplinary endeavor and that working arrangements must facilitate collaboration. The role of the patient as the fulcrum of that team is an important consideration [94][95][96].…”