title: 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.
authors.affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
authors.forename: Martin A
authors.initials: MA
authors.lastname: Denvir
authors.affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cudmore
authors.affiliation: Primary Palliative Care Research Group, Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
authors.forename: Gill
authors.initials: G
authors.lastname: Highet
authors.affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
authors.forename: Shirley
authors.initials: S
authors.lastname: Robertson
authors.affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Donald
authors.affiliation: Edinburgh Clinical Trials Unit, University of Edinburgh, Outpatients Building, Floor Two, Room D36, Western General Hospital, Crewe Road South, Edinburgh, EH4 2XU, UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Stephen
authors.affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
authors.forename: Kristin
authors.initials: K
authors.lastname: Haga
authors.affiliation: Cardiology Department, Glasgow Royal Infirmary, Castle Street, Glasgow, G4 0SF, UK.
authors.forename: Karen
authors.initials: K
authors.lastname: Hogg
authors.affiliation: Edinburgh Health Services Research Unit, Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Weir
authors.affiliation: Primary Palliative Care Research Group, Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Murray
authors.affiliation: Primary Palliative Care Research Group, Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Boyd
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy; D032722:Advance Care Planning; D001007:Anxiety / Q000209:etiology*; D005240:Feasibility Studies; D006333:Heart Failure / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy; D011788:Quality of Life