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: 10537989
• 负责人: Sameer Dev Saini
• 金额: $ 53.71万
• 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 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10537989
• 关键词: Address; Awareness; Behavioral; Cancer Patient; Caring; Castration; Chemicals; Decision Making; Deimplementation; Development; Formularies; Fostering; Health Benefit; Health Care Costs; Injectable; Integrated Delivery Systems; Intervention; Interview; Malignant Neoplasms; Malignant neoplasm of prostate; Medical; Methods; Myocardial Infarction; Osteoporosis; Outcome; Patient-Focused Outcomes; Patients; Personal Satisfaction; Pharmaceutical Preparations; Physicians; Policies; Preparation; Prostate Cancer therapy; Provider; Randomized; Research Methodology; Sex Functioning; Surveys; Theoretical Domains framework; Urologist; Work; acceptability and feasibility; androgen deprivation therapy; base; cancer care; clinical practice; comparative effectiveness trial; design; effectiveness trial; evidence base; experimental study; implementation barriers; implementation evaluation; implementation intervention; implementation research; implementation science; implementation strategy; improved; innovation; male; men; novel; patient safety; preference; programs; shared decision making; symptomatic improvement; theories; trial comparing

Modified Project Summary/Abstract Section 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.

修改项目摘要/摘要部分 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个时候用长效注射药物进行化学阉割（即，雄激素剥夺疗法或ADT）。这每年影响着成千上万人的福祉。虽然一些患者在生存和症状改善方面受益，但当对患者的健康益处很少或没有时，也通常使用ADT进行化学去势，从而引起低价值护理的问题。越来越多的人意识到阉割的危害（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，如在证据基础之外对患有ADT的前列腺癌患者进行化学阉割，是取消实施的理想目标。取消实施或停止低价值的做法，有可能改善患者的治疗效果并降低医疗成本。然而，供应商的偏好，关于去执行没有得到很好的理解，可能的去执行干预措施范围从生硬的处方限制政策，以共同决策。这两种干预策略都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，包括试验前的试点。由于许多医疗实践缺乏证据，造成伤害，强大的，基于行为理论的方法，将供应商的偏好到去实现策略的发展将推进实施研究和实践。 项目目标：本研究将使用基于理论的混合方法，识别、定制和试点两种不同的取消实施策略，这两种策略在交付、影响和预期结果方面差异很大，以减少低价值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。目的1：评估在前列腺癌中取消化学去势的偏好和障碍。在理论领域框架的指导下，来自综合交付系统中去势率最高的机构的泌尿科医生将接受采访，以确定减少去势作为前列腺癌治疗的关键偏好和取消实施障碍。这项定性工作将为目标2提供信息，同时为两项拟议的试点干预战略收集丰富的信息。目标2：使用离散选择实验，一种新的障碍优先级的方法，去实现策略剪裁。一项针对泌尿科医生的全国性调查将使用离散选择实验设计优先考虑目标1中确定的停止去势作为局部前列腺癌治疗的关键障碍。这些量化结果将确定最重要的障碍，通过调整两个试点取消执行战略，为目标3的试点做准备。目标3：试点两个量身定制的去执行策略，以减少去势作为局部前列腺癌治疗。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，另一种策略将侧重于医生/患者决策。结果将包括可接受性，可行性和可扩展性，为有效性试验做准备，比较这两种差异很大的去执行战略。这种创新的方法去执行策略的发展将改变如何以及为什么阉割是通过结合提供者的偏好和策略定制局部前列腺癌。这项工作将推进低价值癌症护理的去执行科学，并通过试点定制解决偏好和关切，促进参与随后的去执行评估试验。