Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial.

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial.
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DOI:
10.1136/bmjopen-2020-042620
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发表时间:
2021-02-22
期刊:
影响因子:
2.9
通讯作者:
Eneanya ND
Eneanya ND
中科院分区:
医学3区
文献类型:
--
作者:
Stallings TL;Temel JS;Klaiman TA;Paasche-Orlow MK;Alegria M;O'Hare A;O'Connor N;Dember LM;Halpern SD;Eneanya ND

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晚期慢性肾脏病(CKD)患者的透析前教育通常仅限于血液透析和腹膜透析作为未来的治疗选择。然而,年龄较大或病情严重的患者可能不想进行透析和/或可能无法从这种治疗中受益。保守的肾脏管理、合理的替代治疗和高级护理计划(ACP)经常被排除在患者教育和共享决策之外。在这项研究中,我们将试行一项教育干预(保守肾脏管理选项和高级护理计划教育-COPE),以提高年龄较大和/或功能状况较差的晚期CKD患者对保守肾脏管理和ACP的知识。这是在宾夕法尼亚州费城的一个学术中心进行的单中心试点随机对照试验。符合条件的患者将具有:年龄≥70岁和/或较差的功能状态(根据卡诺夫斯基绩效指数评分和/或70),晚期慢性肾脏病(估计肾小球滤过率和20 毫升/分钟/1.73 m2),在临床会面时更喜欢说英语,并自我报告为黑人或白人。登记的患者将按种族1:1随机分组,接受加强的常规护理或常规护理,以及关于保守肾脏管理和ACP(COP)的面对面教育。主要结果是对CKM和ACP的认识发生了变化。我们还将探讨干预的可行性和可接受性、偏好传播的变化以及干预对知识和种族偏好传播的影响的差异。我们将在基线、教育后立即以及2周和12周评估结果。该议定书已得到宾夕法尼亚大学机构审查委员会的批准。我们将从所有参与者那里获得书面知情同意。这项工作的成果将在学术会议上提出,并通过同行评议的期刊传播。这项试验在ClinicalTrials.gov上注册,编号为NCT03229811。
Predialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education—COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status. This is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ≥70 years and/or poor functional status (as defined by Karnofsky Performance Index Score <70), advanced CKD (estimated glomerular filtration rate<20 mL/min/1.73 m2), prefer to speak English during clinical encounters and self-report as black or white race. Enrolled patients will be randomised 1:1, with stratification by race, to receive enhanced usual care or usual care and in-person education about conservative kidney management and ACP (COPE). The primary outcome is change in knowledge of CKM and ACP. We will also explore intervention feasibility and acceptability, change in communication of preferences and differences in the intervention’s effects on knowledge and communication of preferences by race. We will assess outcomes at baseline, immediately post-education and at 2 and 12 weeks. This protocol has been approved by the Institutional Review Board at the University of Pennsylvania. We will obtain written informed consent from all participants. The results from this work will be presented at academic conferences and disseminated through peer-reviewed journals. This trial is registered at ClinicalTrials.gov under NCT03229811.
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