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临床试验/NCT06199986
NCT06199986已完成不适用

De-implementation of Low Value Castration for Men With Prostate Cancer - Living Well With Prostate Cancer

University of Michigan2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Effectiveness - Interruption in Low Value ADT Injection (i.e., Take a Break From ADT)

研究概览

简要总结

The goal of this randomized de-implementation trial is to compare two strategies to reduce low-value androgen deprivation therapy (ADT) use for prostate cancer care. The aim of the study is to compare implementation of the two strategies: use of a clinical reminder order check intervention versus a provider script/patient education approach, and their impacts on low-value ADT use after six months. The main goal of both interventions will be to decrease ADT overuse for patients with prostate cancer, but to do this in a way that is acceptable to the clinicians who treat these patients. The interventions will be initiated for providers only across 4 participating facilities. Provider participants will engage with one of the interventions triggered in the electronic health record when their patients are deemed likely to be receiving low-value ADT. Each provider participant receives only one of the interventions. The intervention is triggered for every clinic visit involving a patient deemed to be receiving low-value ADT, so provider participants may receive their assigned intervention multiple times. Researchers will compare provider use of both strategies to determine implementation outcomes and whether one was more effective in reducing low-value ADT use.

详细描述

Project Background:

Prostate cancer is a 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). 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 and overuse. A growing awareness of castration harms (e.g., heart attack, osteoporosis, loss of sexual function) also creates patient safety concerns. Despite this, ADT use in low-value cases, such as for localized prostate cancer treatment and biochemical recurrence in non-metastatic disease 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. For example, stopping low-value chemical castration overuse could prevent harm, limit spending, and maintain survival. 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. Blunt policy interventions such as formulary restriction of ADT (e.g., pre-authorization, order templates) might seem warranted given patient safety concerns, yet could result in significant provider resistance and work-arounds if introduced poorly. More nuanced, patient-centered interventions such as shared decision-making (e.g., decision aid, talking points) likely involve extra clinical time. 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 de-implementation strategy development will advance both implementation research and practice.

Project Objectives:

This study will compare two different de-implementation strategies that vary in delivery, impact, and expected results for reducing low-value ADT use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Any provider at participating sites who prescribes ADT for prostate cancer patients

排除标准

  • Providers opting out of study

研究组 & 干预措施

ADT Order Check Attestation (Or)

Experimental

Study staff will place a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team have confirmed to be targets for ADT de-implementation. Health factors will be entered as eligible clinic visits are identified. This health factor combined with a low PSA level (most recent PSA < 2) will trigger the ADT Order Check Attestation Intervention (Or) when the provider participant places an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants may override the order check by entering text indicating the reason and continue with the ordering process.

干预措施: ADT Order Check Attestation (Or) (Behavioral)

Provider Script (Sc)

Experimental

Study staff will enter an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note will include scripted talking points for the provider participant to help with discussion and recent PSA levels and can be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note will prompt provider participants to indicate whether a patient prefers to continue or discontinue ADT. The progress note will include links to a patient-facing clinic handout which will be posted on an external website. Provider participants may modify, ignore, or delete the progress note.

干预措施: Provider Script (Sc) (Behavioral)

Control

No Intervention

The study team will match up to 8 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions have been deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period will be ascertained through chart review and compared to intervention site primary outcomes.

结局指标

主要结局

Effectiveness - Interruption in Low Value ADT Injection (i.e., Take a Break From ADT)

时间窗: 6 months

The proportion of patients receiving ADT whose prescribed ADT injections were interrupted, as shown by count of patients whose injections were interrupted.

次要结局

  • Reach(6 months)
  • Penetration - ADT Order Check Attestation (OR) Intervention(6 months)
  • Penetration - Provider Script (SC) Intervention(6 months)
  • Feasibility - Site Level: Medical Center Director (MCD) Approval(Within 1 month of request to participate being sent)
  • Feasibility - Site Level: Fully Operationalized Intervention(6 months)
  • Feasibility - Clinic Level Activation: Clinics With Intervention Implementation(Within 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameer D. Saini

Professor

University of Michigan

研究点 (2)

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