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基于网络的决策辅助工具对社会经济弱势患者参与乳房手术决策的影响:阶梯楔形临床试验(联盟-A231701CD)

Impact of a Web-Based Decision Aid on Socioeconomically Disadvantaged Patients' Engagement in Breast Surgery Decision-Making: Stepped-Wedge Clinical Trial (Alliance-A231701CD).

作者信息

Schumacher Jessica R, Hanlon Bret M, Zahrieh David, Rathouz Paul J, Tucholka Jennifer L, McKinney Grace, Tan Angelina D, Breuer Catherine R, Bailey Lisa, Higham Anna M, Wecsler Julie S, Arnold Alicia H, Froix Anthony J, Dull Scott, Abbott Andrea M, Fine Stephanie G, McGuire Kandace P, Seydel Anna S, McNamara Patricia, Chow Selina, Neuman Heather B

机构信息

University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.

出版信息

Ann Surg Oncol. 2025 May 17. doi: 10.1245/s10434-025-17452-0.

Abstract

BACKGROUND

Decision aids (DAs) may increase engagement in decision-making by addressing barriers that disproportionately impact socioeconomically disadvantaged patients. The impact of a breast cancer surgery DA on increasing patient engagement in decision-making was tested in clinics serving a high proportion of socioeconomically disadvantaged patients.

METHODS

A stepped-wedge trial was conducted with 10 National Cancer Institute Community Oncology Research Program clinics (Alliance for Clinical Trials in Oncology, June 2019 to December 2021). The clinics were randomized to time of transition from usual care (UC) to delivery of a web-based DA. Patients with stages 0-3 breast cancer eligible for surgery provided consent before a surgical consultation. Engagement was measured by Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI-5, follow-up survey) and count of Active Patient Behaviors (audio-recorded consultation). Intervention effects were tested with linear mixed-effects models, accounting for surgeon and clinic-level clustering, time, and enrollment after COVID. Heterogeneity of treatment effect by socioeconomic disadvantage (using the Area Deprivation Index) was assessed with an interaction term.

RESULTS

The study enrolled 576 patients, and 44 % (136/309) of the patients reviewed the DA. No significant difference in engagement was observed between DA and UC for PEPPI-5 (- 0.8; 95 % CI, - 2.1-0.6; p = 0.260) or Active Patient Behaviors (2.5; 95 % CI, - 4.1-9.2; p = 0.456). No heterogeneity of treatment effect was observed. Socioeconomic disadvantage was associated with fewer Active Patient Behaviors (- 5.9; 95 % CI, - 0.6-- 1.2; p = 0.013).

CONCLUSION

This trial conducted in clinics that serve diverse populations, observed no significant relationship between a web-based DA and patient engagement. Future analyses will explore DA implementation, characteristics of patients who reviewed the DA, and persistent barriers to engagement.

摘要

背景

决策辅助工具(DAs)可通过消除对社会经济弱势患者影响尤甚的障碍,来提高其参与决策的程度。在为社会经济弱势患者比例较高的诊所中,对一款乳腺癌手术决策辅助工具在提高患者决策参与度方面的影响进行了测试。

方法

在10家美国国立癌症研究所社区肿瘤研究项目诊所开展了一项阶梯楔形试验(肿瘤临床试验联盟,2019年6月至2021年12月)。这些诊所被随机分配从常规护理(UC)过渡到提供基于网络的决策辅助工具的时间。符合手术条件的0至3期乳腺癌患者在进行手术咨询前提供了知情同意书。通过患者在医患互动中的自我效能感(PEPPI - 5,随访调查)和积极患者行为计数(录音咨询)来衡量参与度。使用线性混合效应模型测试干预效果,该模型考虑了外科医生和诊所层面的聚类、时间以及新冠疫情后的入组情况。通过一个交互项评估社会经济劣势(使用地区贫困指数)对治疗效果的异质性。

结果

该研究共纳入576例患者,44%(136/309)的患者查看了决策辅助工具。对于PEPPI - 5(-0.8;95%置信区间,-2.1 - 0.6;p = 0.260)或积极患者行为(2.5;95%置信区间,-4.1 - 9.2;p = 0.456),在决策辅助工具组和常规护理组之间未观察到参与度的显著差异。未观察到治疗效果的异质性。社会经济劣势与较少的积极患者行为相关(-5.9;95%置信区间,-11.2 - -0.6;p = 0.013)。

结论

在服务于不同人群的诊所中进行的这项试验,未观察到基于网络的决策辅助工具与患者参与度之间存在显著关系。未来的分析将探讨决策辅助工具的实施情况、查看决策辅助工具的患者特征以及持续存在的参与障碍。

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