Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention.
Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention.
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DOI：
10.1136/bmjopen-2015-009032
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发表时间：
2015-10-06
期刊：
影响因子：
2.9
通讯作者：
Block SD
中科院分区：
文献类型：
--
作者：
Bernacki R;Hutchings M;Vick J;Smith G;Paladino J;Lipsitz S;Gawande AA;Block SD
确保患者获得符合其目标和价值观的护理是高质量护理的关键组成部分。本文介绍了多组分，结构化的沟通干预的群集随机对照试验的协议。晚期、无法治愈的癌症患者和预期寿命<12个月的患者将与他们的代理人一起参加。 临床医生被招募并随机分配到常规护理或干预。严重疾病护理计划是一个多组件的结构化沟通干预，旨在识别患者，培训临床医生使用结构化指南与患者进行高级护理计划讨论，“触发”临床医生进行对话，为患者和家属进行对话做好准备，并在电子病历中以结构化格式记录讨论结果。将在干预前后评估临床医生对干预的满意度、信心和态度。将大约每2个月收集一次患者和代理人的自我报告数据，最长2年或直至患者死亡;将在研究结束时检查患者病历。 分析将检查干预对患者接受目标一致的护理以及生命结束时的平静的影响。次要结局包括患者焦虑、抑郁、生活质量、治疗联盟、沟通质量以及死亡质量。关键的过程测量包括记录谈话的频率、时间和质量。这项研究得到了Dana-Farber癌症研究所机构审查委员会的批准。结果将在同行评审的出版物和会议报告中报告。方案标识符NCT 01786811;预结果。
Ensuring that patients receive care that is consistent with their goals and values is a critical component of high-quality care. This article describes the protocol for a cluster randomised controlled trial of a multicomponent, structured communication intervention. Patients with advanced, incurable cancer and life expectancy of <12 months will participate together with their surrogate. Clinicians are enrolled and randomised either to usual care or the intervention. The Serious Illness Care Program is a multicomponent, structured communication intervention designed to identify patients, train clinicians to use a structured guide for advanced care planning discussion with patients, ‘trigger’ clinicians to have conversations, prepare patients and families for the conversation, and document outcomes of the discussion in a structured format in the electronic medical record. Clinician satisfaction with the intervention, confidence and attitudes will be assessed before and after the intervention. Self-report data will be collected from patients and surrogates approximately every 2 months up to 2 years or until the patient's death; patient medical records will be examined at the close of the study. Analyses will examine the impact of the intervention on the patient receipt of goal-concordant care, and peacefulness at the end of life. Secondary outcomes include patient anxiety, depression, quality of life, therapeutic alliance, quality of communication, and quality of dying and death. Key process measures include frequency, timing and quality of documented conversations. This study was approved by the Dana-Farber Cancer Institute Institutional Review Board. Results will be reported in peer-reviewed publications and conference presentations. Protocol identifier NCT01786811; Pre-results.