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

修改后的项目摘要/摘要部分 项目背景：前列腺癌是男性首位的癌症。每三名前列腺癌患者中就有一人在某种程度上被长效注射药物(即雄激素剥夺疗法或ADT)化学阉割。这每年影响数以千计的男性的福祉。虽然一些患者在存活和症状改善方面受益，但当患者提出低价值护理的问题时，也经常使用ADT进行化学阉割，但对健康几乎没有好处。人们对阉割危害(例如，心脏病发作、骨质疏松症、性功能丧失)的认识日益增强，这引起了对患者安全的担忧。尽管如此，ADT在低价值病例中的使用仍然存在，例如用于局限性前列腺癌的治疗。无效和有害的做法，如对前列腺癌患者进行化学阉割，并在证据库外进行ADT，是取消实施的理想目标。取消实施，或停止低价值做法，有可能改善患者结局，降低医疗成本。然而，提供者对取消执行的偏好没有得到很好的理解，可能的取消执行干预措施从直截了当的公式化限制政策到共同决策。这两种干预策略都需要根据提供者的意见在临床实践中的可接受性和可行性进行调整，包括在试验之前进行试点。由于许多医疗实践缺乏证据并造成危害，基于行为理论的稳健方法将提供者偏好纳入取消实施战略制定，将促进实施研究和实践。 项目目标：这项研究将使用一种基于理论的混合方法来确定、调整和试点两种不同的非实施战略，这两种战略在减少低价值ADT使用方面的交付、影响和预期结果差异很大，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项目有三个目标。目的1：评估前列腺癌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设施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，同时为两个拟议的试点干预战略收集丰富的信息。目的2：使用离散选择实验--一种新的障碍优先排序方法--来进行去实现策略剪裁。一项对泌尿科医生的全国调查将优先考虑目标1中确定的停止去势的关键障碍，作为使用离散选择试验设计的局部前列腺癌治疗。这些量化结果将确定在为目标3试点做准备时，需要通过调整两项试点取消执行战略来解决的最重要障碍。目的3：试验两个量身定制的去实施策略，以减少去势作为局限性前列腺癌治疗的可能性。在目标1和目标2调查结果的基础上，将试行两项取消执行战略。一种战略将侧重于组织层面的处方限制，另一种战略将侧重于医生/患者的决策。结果将包括可接受性、可行性和可扩展性，以准备对这两种差异很大的去实施战略进行有效性试验。这种取消实施策略开发的创新方法将通过结合提供者的偏好和策略定制来改变对局限性前列腺癌进行去势的方式和原因。这项工作将推进低价值癌症护理的去实施科学，并通过试点定制解决偏好和关切，促进参与随后的去实施评估试验。

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.