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晚期心脏病患者未来护理规划的2期随机对照试验及可行性研究

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

作者信息

Denvir Martin A, Cudmore Sarah, Highet Gill, Robertson Shirley, Donald Lisa, Stephen Jacqueline, Haga Kristin, Hogg Karen, Weir Christopher J, Murray Scott A, Boyd Kirsty

机构信息

Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.

Primary Palliative Care Research Group, Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.

出版信息

Sci Rep. 2016 Apr 19;6:24619. doi: 10.1038/srep24619.

DOI:10.1038/srep24619
PMID:27090299
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4836296/
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.

摘要

未来照护规划(FCP)在心脏病患者中很少出现,直到临近死亡时才会进行,而此时潜在的益处已丧失。我们评估了一项随机试验的可行性、可接受性,并测试了该试验的设计,该试验旨在评估FCP对患者及其照护者的影响。50名因急性心力衰竭或急性冠状动脉综合征住院且预计12个月死亡风险>20%的患者在出院后被随机分配至FCP组或常规照护组,为期12周,然后在接下来的12周进行交叉。通过问卷评估生活质量、症状以及焦虑/痛苦程度。记录出院后6个月的住院和死亡事件。FCP增加了与临终照护相关关键决策的实施和记录。FCP并未增加焦虑/痛苦程度(凯斯勒评分-E组16.7(7.0),D组16.8(7.3),p = 0.94)。生活质量未改变(EQ5D-E组0.54(0.29),D组0.56(0.24),p = 0.86),而未调整的住院天数较少(E组8.6(15.3),D组11.8(17.1),p = 0.01)。定性访谈表明,FCP受到患者、照护者和家庭医生的高度重视。FCP在急性高危心脏病患者的随机临床试验中是可行的。迫切需要进行一项3期试验。

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