De-implementation of low value castration for men with prostate cancer

对患有前列腺癌的男性取消低价值阉割的实施

• 批准号: 10558714
• 负责人: Sameer Dev Saini
• 金额: $ 58.48万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-16 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10558714
• 关键词: Address; Authorization documentation; Awareness; Behavioral; Cancer Patient; Caring; Castration; Chemicals; Clinical; Complex; Coupled; Decision Aid; Decision Making; Deimplementation; Development; Drug usage; Experimental Designs; Formularies; Fostering; Health Benefit; Health Care Costs; Iatrogenesis; Injectable; Integrated Delivery Systems; Intervention; Interview; Level of Evidence; Malignant Neoplasms; Malignant neoplasm of prostate; Medical; Methods; Myocardial Infarction; Osteoporosis; Outcome; Patient Preferences; Patient-Focused Outcomes; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacy facility; Physicians; Policies; Preparation; Prostate Cancer therapy; Provider; Quality of Care; Quality of life; Randomized; Research Methodology; Resistance; Science; Sex Functioning; Surveys; Theoretical Domains framework; Time; Urologist; Work; acceptability and feasibility; aging population; androgen deprivation therapy; authority; cancer care; cancer therapy; clinical practice; comparative effectiveness trial; effectiveness trial; evidence base; experimental study; implementation barriers; implementation evaluation; implementation intervention; implementation research; implementation science; implementation strategy; improved; innovation; male; men; novel; operation; patient oriented; patient safety; preference; prevent; programs; shared decision making; symptomatic improvement; theories; therapy development; trial comparing

Project Background: Prostate cancer is the leading male cancer. One in three men with prostate cancer is chemically castrated at some point with long-acting injectable drugs (i.e., androgen deprivation therapy or ADT). This impacts the well-being of thousands of men annually. Although some patients benefit in terms of survival and symptom improvement, chemical castration with ADT is also commonly performed when there are little to no health benefits to patients raising questions of low value care. A growing awareness of castration harms (e.g., heart attack, osteoporosis, loss of sexual function) creates patient safety concerns. Despite this, ADT use in low value cases, such as for localized prostate cancer treatment persists. Ineffective and harmful practices such as chemical castration of prostate cancer patients with ADT outside of the evidence base are ideal targets for de-implementation. De-implementation, or stopping low value practices, has the potential to improve patient outcomes and decrease healthcare costs. However, provider preferences regarding de-implementation are not well understood, and possible de-implementation interventions range from blunt formulary restriction policies to shared decision-making. Both intervention strategies need tailoring based on provider input for acceptability and feasibility in clinical practice, including piloting prior to trialing. As many medical practices lack evidence and cause harm, robust, behavioral theory-based methods for incorporating provider preferences into deimplementation strategy development will advance both implementation research and practice. Project Objectives: This study will use a theory-based, mixed methods approach to identify, tailor and pilot two different de-implementation strategies that vary widely in delivery, impact, and expected results for reducing low value ADT use, in preparation for a randomized comparative effectiveness trial. Project Methods: This innovative mixed-methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the Theoretical Domains Framework, urologists from facilities with the highest castration rates across an integrated delivery system will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment, a novel barrier prioritization approach, for de-implementation strategy tailoring. A national survey of urologists will prioritize key barriers identified in Aim 1 for stopping castration as localized prostate cancer treatment using a discrete choice experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient decision-making. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. This innovative approach to de-implementation strategy development will transform how and why castration is performed for localized prostate cancer through combining provider preferences and strategy tailoring. This work will advance de-implementation science for low value cancer care and foster participation in a subsequent de- implementation evaluation trial by addressing preferences and concerns through pilot tailoring.

项目背景：前列腺癌是男性癌症中的第一位。三分之一的前列腺癌患者 在某些时候用长效注射药物化学阉割（即，雄激素剥夺治疗或 ADT）。这每年影响着成千上万人的福祉。虽然有些患者在治疗方面受益， 生存和症状改善，当存在以下情况时，也通常使用ADT进行化学去势： 对患者几乎没有健康益处，这引发了低价值护理的问题。越来越意识到 阉割伤害（例如，心脏病发作、骨质疏松症、性功能丧失）引起患者安全问题。 尽管如此，ADT在低价值病例中的使用，如局部前列腺癌治疗仍然存在。 无效和有害的做法，如化学阉割前列腺癌患者ADT外 证据库中的信息是取消执行的理想目标。取消执行，或停止低值 实践，有可能改善患者的治疗效果，降低医疗成本。然而，供应商 关于取消执行的偏好还没有得到很好的理解， 干预措施包括从生硬的处方限制政策到共同决策。两种干预 策略需要根据提供者的意见进行调整，以确保临床实践的可接受性和可行性，包括 在试航前进行试航。由于许多医疗实践缺乏证据并造成伤害， 将供应商偏好纳入去实现战略开发的基于理论的方法 将推动实施研究和实践。 项目目标：本研究将使用基于理论的混合方法来确定、调整和试点 两种不同的取消执行战略，在交付、影响和预期结果方面差异很大， 减少低价值ADT的使用，为随机比较有效性试验做准备。 项目方法：这个创新的混合方法研究计划有三个目标。目标1：评估 在前列腺癌中取消化学阉割的偏好和障碍。为指导 理论领域框架，泌尿科医生从设施与最高的阉割率在整个 将对综合交付系统进行访谈，以确定主要偏好和取消实施的障碍， 减少去势作为前列腺癌治疗。这项定性工作将为目标2提供信息，同时收集丰富的 为两项拟议的试点干预战略提供信息。目的2：使用离散选择实验， 新的障碍优先化方法，用于去实现策略定制。全国泌尿科医生调查 将优先考虑目标1中确定的关键障碍，以停止去势作为局部前列腺癌治疗 使用离散选择实验设计。这些定量结果将确定最重要的 为实现目标3，通过调整两项试点执行战略来消除障碍 驾驶目标3：试验两种量身定制的去实施策略，以减少去势作为局限性前列腺 癌症治疗根据目标1和2的调查结果，将试行两项取消执行战略。 一种策略将侧重于组织层面的处方集限制，另一种侧重于医生/患者 决策的结果将包括可接受性、可行性和可扩展性，为 有效性试验比较这两个差异很大的去实现战略。这一创新 反实施策略制定方法将改变执行阉割的方式和原因 通过结合提供者偏好和策略定制来治疗局限性前列腺癌。这项工作将 推进低价值癌症护理的实施科学，并促进参与随后的实施， 执行情况评价试验，通过试点调整来解决偏好和关切问题。

项目成果

Understanding the Role of Urology Practice Organization and Racial Composition in Prostate Cancer Treatment Disparities.

了解泌尿外科实践组织和种族构成在前列腺癌治疗差异中的作用。

• DOI: 10.1200/op.22.00147
• 发表时间: 2023
• 期刊: JCO oncology practice
• 影响因子: 4
• 作者: Agochukwu-Mmonu,Nnenaya;Qin,Yongmei;Kaufman,Samuel;Oerline,Mary;Vince,Randy;Makarov,Danil;Caram,MeganV;Chapman,Christina;Ravenell,Joseph;Hollenbeck,BrentK;Skolarus,TedA
• 通讯作者: Skolarus,TedA

Using an Automated Electronic Health Record Score To Estimate Life Expectancy In Men Diagnosed With Prostate Cancer In The Veterans Health Administration.

• DOI: 10.1016/j.urology.2021.05.056
• 发表时间: 2021-09
• 期刊: Urology
• 影响因子: 2.1
• 作者: Soerensen SJC;Thomas IC;Schmidt B;Daskivich TJ;Skolarus TA;Jackson C;Osborne TF;Chertow GM;Brooks JD;Rehkopf DH;Leppert JT
• 通讯作者: Leppert JT

Envisioning clinical trials as complex interventions.

• DOI: 10.1002/cncr.34357
• 发表时间: 2022-09-01
• 期刊: Cancer
• 影响因子: 6.2

Mental health care utilization among men with castration-resistant prostate cancer receiving abiraterone or enzalutamide.

• DOI: 10.1002/cam4.6237
• 发表时间: 2023-08
• 期刊: CANCER MEDICINE
• 影响因子: 4
• 作者: Tsao, Phoebe A.;Burns, Jennifer;Kumbier, Kyle;Sparks, Jordan B.;Entenman, Shami;Bloor, Lindsey E.;Bohnert, Amy S. B.;Skolarus, Ted A.;Caram, Megan E. V.
• 通讯作者: Caram, Megan E. V.

Comparison of the treatment of men with prostate cancer between the US and England: an international population-based study.

美国和英国男性前列腺癌治疗的比较：一项基于国际人群的研究。

• DOI: 10.1038/s41391-021-00482-6
• 发表时间: 2023
• 期刊: Prostate cancer and prostatic diseases
• 影响因子: 4.8
• 作者: Parry,MatthewG;Nossiter,Julie;Morris,Melanie;Sujenthiran,Arunan;Skolarus,TedA;Berry,Brendan;Nathan,Arjun;Cathcart,Paul;Aggarwal,Ajay;vanderMeulen,Jan;Trinh,Quoc-Dien;Payne,Heather;Clarke,NoelW
• 通讯作者: Clarke,NoelW