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同伴指导改善血液透析患者结局(PEER-HD):一项随机对照试验方案。

Peer mentorship to improve outcomes in patients on hemodialysis (PEER-HD): a randomized controlled trial protocol.

机构信息

Department of Medicine, Division of Nephrology, Albert Einstein College of Medicine/ Montefiore Medical Center, Bronx, NY, 10467, USA.

Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, 10461, USA.

出版信息

BMC Nephrol. 2022 Mar 5;23(1):92. doi: 10.1186/s12882-022-02701-1.

Abstract

BACKGROUND

Patients receiving in-center hemodialysis experience disproportionate morbidity and incur high healthcare-related costs. Much of this cost stems from potentially avoidable hospitalizations. Peer mentorship has been used effectively to improve outcomes for patients with complex chronic diseases. We propose testing the efficacy of peer mentorship on hospitalization rates among patients receiving hemodialysis.

METHODS

This is a multicenter parallel group randomized controlled pragmatic trial of patients treated at hemodialysis facilities in Bronx, NY and Nashville, TN. The study has two phases. Phase 1 will enroll and train 16 hemodialysis patients (10 in Bronx, NY and 6 in Nashville TN) to be mentors using a program focused on enhancing self-efficacy, dialysis self-management and autonomy-supportive communication skills. Phase 2 will enroll 200 high risk adults receiving hemodialysis (140 in Bronx, NY and 60 in Nashville, TN), half of whom will be randomized to intervention and half to usual care. Intervention participants are assigned to weekly telephone calls with trained mentors (see Phase 1) for a 3-month period. The primary outcome of Phase 1 will be engagement of mentors with training and change in knowledge scores and autonomy skills from pre- to post-training. The primary outcome of Phase 2 will be the composite count of ED visits and hospitalizations at the end of study follow-up in patient participants assigned to intervention as compared to those assigned to usual care. Secondary outcomes for Phase 2 include the change over the trial period in validated survey scores measuring perception of social support and self-efficacy, and dialysis adherence metrics, among intervention participants as compared to usual care participants.

DISCUSSION

The PEER-HD study will test the feasibility and efficacy of a pragmatic peer-mentorship program designed for patients receiving hemodialysis on ED visit and hospitalization rates. If effective, peer-mentorship holds promise as a scalable patient-centered intervention to decrease hospital resource utilization, and by extension morbidity and cost, for patients receiving maintenance in-center hemodialysis.

TRIAL REGISTRATION

Clinicaltrials.gov identifier: NCT03595748 ; 7/23/2018.

TRIAL SPONSOR

National Institutes of Diabetes, Digestive and Kidney Disease (NIDDK) 5R18DK118471.

FUNDING

Funding for this study was provided by the National Institutes of Diabetes, Digestive and Kidney Disease: R18DK118471.

STUDY STATUS

This is an ongoing study and not complete. We are still collecting data for observational follow-up on participants.

RELATED ARTICLES

No related articles for this study have been submitted to any journal. The study sponsor and funders had no role in the design, analysis or interpretation of this data. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

摘要

背景

在中心接受血液透析的患者经历了不成比例的发病率,并产生了高昂的医疗保健相关费用。其中大部分费用源于潜在可避免的住院治疗。同行指导已被有效用于改善患有复杂慢性疾病的患者的治疗效果。我们提出测试同行指导对接受血液透析患者的住院率的影响。

方法

这是一项在纽约布朗克斯和纳什维尔接受血液透析治疗的患者中进行的多中心平行组随机对照实用临床试验。该研究分为两个阶段。第一阶段将招募并培训 16 名血液透析患者(10 名在布朗克斯,6 名在纳什维尔),使用一个专注于增强自我效能、透析自我管理和自主支持沟通技巧的项目,将他们培训为导师。第二阶段将招募 200 名高危接受血液透析的成年人(140 名在布朗克斯,60 名在纳什维尔),其中一半将随机分配到干预组,一半分配到常规护理组。干预组参与者将在 3 个月的时间内每周与经过培训的导师进行一次电话交流。第一阶段的主要结果将是导师的参与度、培训前后知识得分和自主技能的变化。第二阶段的主要结果将是与接受常规护理的患者相比,接受干预的患者在研究随访结束时急诊就诊和住院的复合计数。第二阶段的次要结果包括与常规护理组相比,试验期间干预组参与者在验证性调查评分中感知社会支持和自我效能以及透析依从性指标的变化。

讨论

PEER-HD 研究将测试针对接受血液透析患者的实用同行指导计划的可行性和疗效,以降低急诊就诊和住院率。如果有效,同行指导有望成为一种可扩展的以患者为中心的干预措施,以减少接受维持性中心血液透析患者的医院资源利用,从而降低发病率和成本。

试验注册

Clinicaltrials.gov 标识符:NCT03595748;2018 年 7 月 23 日。

试验赞助商

美国国立糖尿病、消化和肾脏疾病研究所(NIDDK)5R18DK118471。

资金

本研究的资金由美国国立糖尿病、消化和肾脏疾病研究所提供:R18DK118471。

研究状况

这是一项正在进行的研究,尚未完成。我们仍在收集参与者的观察性随访数据。

相关文章

没有提交给任何期刊的相关文章。研究赞助商和资助者在设计、分析或解释这些数据方面没有任何作用。内容完全由作者负责,并不一定代表美国国立卫生研究院的官方观点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e66/8897860/6193a9d8cfc5/12882_2022_2701_Fig1_HTML.jpg

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