预防高合并症患者的“引爆点”：来自健康教练的生命线——基本原理、设计和方法。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-28 DOI:10.1016/j.cct.2025.107865

Mary E. Charlson , Ilana Mittleman , Rosio Ramos , Andrea Cassells , T.J. Lin , Alice Eggleston , Martin T. Wells , James Hollenberg , Paul Pirraglia , Ginger Winston , Jonathan N. Tobin

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引用次数: 0

摘要

背景：本文描述了一项创新的聚类随机对照试验设计，以评估两种方法在预防严重不稳定（导致高合并症患者意外住院和残疾增加）的比较有效性，高合并症患者是指由增强的Charlson合并症指数≥4定义的多种慢性疾病。方法：共有1974名患者在四个卫生系统（两个在纽约，两个在芝加哥）的16个联邦合格卫生中心（fqhc）中随机分为四组。两种干预措施比较：(1)fqhc（常规护理对照）实施的以患者为中心的医疗之家（PCMH）；或2)PCMH加上由健康教练提供的指导干预（实验），帮助患者确定生活目标，鼓励通过积极影响/自我肯定策略加强自我管理。两个主要的以患者为中心的临床结局是：1)计划外住院；2)患者内部生活质量和残疾的变化，由世界卫生组织残疾评估量表2 （WHODAS 2.0）衡量。假设是：1)与对照组患者相比，干预患者的计划外住院相对减少5% %；2) WHODAS2.0测量的残疾程度降低；3)导致住院的不稳定或“临界点”往往是由心理社会问题而不是医疗问题引发的。结论：通过激励患者参与自我管理，并成功应对导致不稳定、住院和残疾增加的障碍、挑战和压力，该集群RCT有可能改变对高合并症患者的护理。临床试验：政府注册号：NCT04176510。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Preventing “tipping points” in high comorbidity patients: A lifeline from health coaches – rationale, design and methods

Background

This paper describes an innovative cluster randomized controlled trial design to evaluate the comparative effectiveness of two approaches to preventing significant destabilization, leading to unplanned hospitalization and increased disability for patients with high comorbidity, that is, multiple chronic diseases defined by an enhanced Charlson Comorbidity Index ≥4.

Methods

A total of 1974 patients were randomized in four waves at each of the sixteen Federally Qualified Health Centers (FQHCs) in four health systems —two in New York and two in Chicago.

The two interventions compared 1) Patient-Centered Medical Home (PCMH) as implemented by the FQHCs (usual care control); or 2) PCMH plus a coaching intervention delivered by Health Coaches (experimental) helping patients identify life goals to encourage self-management enhanced by a positive affect/self-affirmation strategy.

The two primary patient-centered clinical outcomes are 1) Unplanned hospitalizations; and 2) Within-patient changes in quality of life and disability, as measured by the World Health Organization Disability Assessment Scale 2 (WHODAS 2.0).

The hypotheses are: 1) intervention patients will have a 5 % relative reduction in unplanned hospitalizations as compared to control patients; and 2) reduced disability measured by WHODAS2.0; 3) destabilization or ‘tipping points’ leading to hospitalization will be more often triggered by psychosocial issues than by medical Issues.

Conclusion

This cluster RCT has the potential to transform the care for patients with high comorbidity by helping motivate patients to engage in self-management and to successfully navigate the barriers, challenges, and stresses leading to destabilization, hospitalization, and increased disability.

ClinicalTrials.gov registration number: NCT04176510

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.