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急症医学舒缓医疗服务获取(EMPallA):一项多中心随机对照试验的方案,旨在比较专科门诊与护士主导的电话舒缓医疗对老年晚期疾病患者的有效性。

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness.

机构信息

Ronald O Perelman Department of Emergency Medicine, New York University School of Medicine, New York, NY.

Augusta University Medical College of Georgia, Augusta, Georgia, USA.

出版信息

BMJ Open. 2019 Jan 25;9(1):e025692. doi: 10.1136/bmjopen-2018-025692.

Abstract

INTRODUCTION

Emergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.

METHODS AND ANALYSIS

This is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.

ETHICS AND DISSEMINATION

Institutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

NCT03325985; Pre-results.

摘要

简介

急诊(ED)启动的姑息治疗已被证明可以改善患有严重、生命有限疾病的老年患者的以患者为中心的结局。然而,提供此类干预措施的最佳方式尚不清楚。本研究旨在比较护士主导的电话病例管理与专科门诊姑息治疗对患有严重、生命有限疾病的老年人的影响:(1)患者的生活质量;(2)医疗保健利用;(3)孤独感和症状负担;以及(4)照顾者负担、照顾者生活质量和丧亲之痛。

方法和分析

这是一项关于在 ED 患者中比较两种已建立的姑息治疗模式(护士主导的电话病例管理和专科门诊姑息治疗)的实用、多中心、平行、双臂随机对照试验的方案。我们将在 9 个 ED 招募 1350 名 50 岁以上的患者和 675 名患者的照顾者。符合条件的患者:(1)患有晚期癌症(转移性实体瘤)或终末期器官衰竭(纽约心脏协会 III 或 IV 级心力衰竭,肾小球滤过率<15mL/min/m 的终末期肾病,或慢性阻塞性肺疾病全球倡议 III、IV 期或需要吸氧的慢性阻塞性肺病);(2)会讲英语;(3)计划从 ED 出院或观察状态;(4)居住在当地;(5)有一部工作电话;以及(6)有保险。如果患者患有痴呆症;(2)在过去 6 个月内接受过临终关怀或两次或更多次姑息治疗;或(3)居住在长期护理机构,则将被排除在外。我们将使用患者级别的块随机化,按 ED 地点和疾病分层。将通过测量每种干预措施对指定结局的影响来比较有效性。主要结局将衡量患者生活质量的变化。

伦理和传播

所有研究地点均获得机构审查委员会的批准。试验结果将提交给同行评审期刊发表。

试验注册号

NCT03325985;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9aea/6347856/e1bb68ec5774/bmjopen-2018-025692f01.jpg

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