Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers.
Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers.
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DOI：
10.1186/s13063-021-05064-4
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发表时间：
2021-02-10
期刊：
影响因子：
2.5
通讯作者：
Ravenell JE
中科院分区：
文献类型：
--
作者：
Makarov DV;Feuer Z;Ciprut S;Lopez NM;Fagerlin A;Shedlin M;Gold HT;Li H;Lynch G;Warren R;Ubel P;Ravenell JE
黑人男性受前列腺癌的影响不成比例，前列腺癌是美国男性中最常见的非皮肤恶性肿瘤。美国预防服务工作组（USPSTF）鼓励前列腺特异性抗原（PSA）检测决策基于共享决策（SDM）临床医生专业判断和患者偏好。然而，有证据表明，SDM在临床实践中未得到充分利用，特别是在最脆弱的患者中。本研究的目的是评估社区卫生工作者（CHW）领导的决策指导计划，以促进SDM的黑人男性在初级保健设置中的前列腺癌筛查的疗效，最终目的是提高/优化决策质量。我们提出了一个CHW领导的决策指导计划，以促进SDM的前列腺癌筛查讨论在黑人男性在初级保健CNOHC。这项研究招募了参与临床研究中心的黑人男性患者和多达15名照顾他们的提供者。我们估计招募了228名年龄在40 - 69岁之间的参与者，随机分配至（1）决策辅助沿着来自CHW的PSA筛查决策辅导组或（2）接受决策辅助沿着CHW主导的关于改变饮食和生活方式的互动，以作为注意力控制组。在每个提供者中实施独立的随机化过程，我们通过将患者分为两个分层来控制年龄：40 - 54岁和55 - 69岁。这一样本量足以支持主要研究结局的检测差异：知识、决策质量的指示和PSA筛查率的差异。患者的主要结局指标将是决策质量和是否接受PSA筛查的决策。提供者的主要结果指标是干预的可接受性和可行性。我们将研究如何决策辅导前列腺癌筛查影响医患沟通。这些结果将通过客观的，有效的尺度进行定量分析，并通过半结构化的，深入的访谈和临床遇到的主题分析进行定性分析。通过一个概念模型相结合的要素的替代性医疗保健模式（PHM）和知情决策模型，我们假设，前列腺癌筛查决策辅导干预将导致偏好一致的决定和决策满意度。我们还假设，这种干预将提高医生对前列腺癌筛查咨询患者的满意度。决策指导是一种以证据为基础的方法，以提高决策质量，在许多临床情况下，但其有效性是不完全探讨PSA筛查黑人男性在初级保健。我们建议评估CHW领导的PSA筛查决策指导计划具有很高的可扩展性和公共卫生影响潜力。我们的研究结果将确定社区诊所环境中CHW干预的有效性，成本效益和可持续性，以便为随后的广泛传播提供信息，这是USPSTF强调的一个关键研究领域。该试验于2018年10月31日在美国国立卫生研究院登记处（www.example.com）进行了前瞻性登记，登记号为NCT 03726320。在线版本包含补充材料，可通过10.1186/s13063 - 021 - 05064 - 4获得。
Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specific antigen (PSA) testing decisions to be based on shared decision-making (SDM) clinician professional judgment, and patient preferences. However, evidence suggests that SDM is underutilized in clinical practice, especially among the most vulnerable patients. The purpose of this study is to evaluate the efficacy of a community health worker (CHW)-led decision-coaching program to facilitate SDM for prostate cancer screening among Black men in the primary care setting, with the ultimate aim of improving/optimizing decision quality. We proposed a CHW-led decision-coaching program to facilitate SDM for prostate cancer screening discussions in Black men at a primary care FQHC. This study enrolled Black men who were patients at the participating clinical site and up to 15 providers who cared for them. We estimated to recruit 228 participants, ages 40–69 to be randomized to either (1) a decision aid along with decision coaching on PSA screening from a CHW or (2) receiving a decision aid along with CHW-led interaction on modifying dietary and lifestyle to serve as an attention control. The independent randomization process was implemented within each provider and we controlled for age by dividing patients into two strata: 40–54 years and 55–69 years. This sample size sufficiently powered the detection differences in the primary study outcomes: knowledge, indicative of decision quality, and differences in PSA screening rates. Primary outcome measures for patients will be decision quality and decision regarding whether to undergo PSA screening. Primary outcome measures for providers will be acceptability and feasibility of the intervention. We will examine how decision coaching about prostate cancer screening impact patient-provider communication. These outcomes will be analyzed quantitatively through objective, validated scales and qualitatively through semi-structured, in-depth interviews, and thematic analysis of clinical encounters. Through a conceptual model combining elements of the Preventative Health Care Model (PHM) and Informed Decision-Making Model, we hypothesize that the prostate cancer screening decision coaching intervention will result in a preference-congruent decision and decisional satisfaction. We also hypothesize that this intervention will improve physician satisfaction with counseling patients about prostate cancer screening. Decision coaching is an evidence-based approach to improve decision quality in many clinical contexts, but its efficacy is incompletely explored for PSA screening among Black men in primary care. Our proposal to evaluate a CHW-led decision-coaching program for PSA screening has high potential for scalability and public health impact. Our results will determine the efficacy, cost-effectiveness, and sustainability of a CHW intervention in a community clinic setting in order to inform subsequent widespread dissemination, a critical research area highlighted by USPSTF. The trial was registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov), registration number NCT03726320, on October 31, 2018. The online version contains supplementary material available at 10.1186/s13063-021-05064-4.
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