VA HSR&D Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.
Department of Urology, Dow Division of Health Services Research, University of Michigan Medical School, 1500 E Medical Center Dr, Ann Arbor, MI, 48109, USA.
Implement Sci. 2018 Nov 29;13(1):144. doi: 10.1186/s13012-018-0833-7.
Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comparative effectiveness trial.
METHODS/DESIGN: 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 (TDF), urologists and patients from facilities with the highest and lowest castration rates across the VA 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 (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a DCE 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 informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies.
Our innovative approach to de-implementation strategy development is directly aligned with state-of-the-art complex implementation intervention development and implementation science. This work will broadly advance de-implementation science for low value cancer care, and foster participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through pilot tailoring.
ClinicalTrials.gov Identifier: NCT03579680 , First Posted July 6, 2018.
患有前列腺癌的男性常被施以长效注射药物，即雄激素剥夺疗法（ADT）进行去势治疗。尽管许多患者因此受益，但 ADT 也被用于一些获益甚微或无获益的患者。目前尚不清楚停止这种做法的最佳方法，其范围从药店的简单限制到知情决策。本研究将对两种不同的去执行策略进行完善和试点，以减少 VA 中那些不太可能受益的患者使用 ADT，为比较疗效试验做准备。
方法/设计：本创新混合方法研究项目有三个目标。目标 1：评估在前列腺癌中去执行化学去势的偏好和障碍。在理论领域框架（TDF）的指导下，VA 中实施 ADT 率最高和最低的机构的泌尿科医生和患者将接受访谈，以确定减少作为前列腺癌治疗的去势的关键偏好和去执行障碍。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策略收集丰富的信息。目标 2：使用离散选择实验（DCE），一种新的障碍优先排序方法，对去执行策略进行定制。研究人员将对泌尿科医生进行全国性调查，以使用 DCE 实验设计，根据目标 1 中确定的关键障碍对停止局部前列腺癌治疗中的事件性去势进行优先级排序。这些定量结果将确定通过定制两项试点去执行策略来解决的最重要障碍，为目标 3 的试点做准备。目标 3：试点两种定制的去执行策略，以减少作为局部前列腺癌治疗的去势。基于目标 1 和 2 的发现，将试点两种去执行策略。一种策略将侧重于组织层面的配方限制，另一种策略将侧重于不同医疗机构的医生/患者知情决策。结果将包括可接受性、可行性和可扩展性，为比较这两种差异极大的去执行策略的有效性试验做准备。
我们的去执行策略开发创新方法直接与最先进的复杂实施干预开发和实施科学相一致。这项工作将广泛推进低价值癌症护理的去执行科学，并通过试点定制来解决障碍、促进者和关注点，从而促进参与我们的去执行评估试验。
ClinicalTrials.gov 标识符：NCT03579680，首次报告 2018 年 7 月 6 日。
Zotero 插件