跳至主要内容
临床试验/NCT06006910
NCT06006910已完成不适用

An Electronic Medical Record-Based Nudge Intervention to Reduce Low-Value Axillary Surgery in Older Women With ER+ Breast Cancer

University of Pittsburgh Medical Center1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Rate of SLNB after nudge deployment into the EHR

研究概览

简要总结

The goal of this prospective, historically-controlled, quality improvement project is to determine whether and to what extent an electronic health record (EHR)-based nudge affects rates of sentinel lymph node biopsy (SLNB) in older women with ER+, early-stage, clinically node negative breast cancer.

详细描述

Society of Surgical Oncology (SSO) adopted a series of Choosing Wisely recommendations in an effort to reduce low-value surgeries. One such recommendation, first released in 2016, advocates against routine use of sentinel lymph node biopsy (SLNB) for axillary staging in older women (≥ 70 years old) with early-stage, estrogen receptor positive (ER+), clinically node-negative breast cancer. Data supporting this recommendation were largely retrospective in nature as there were no direct randomized trials testing de-escalation of SLNB in this population of patients. This has led to variability in de-implementation of SLNB, with rates of SLNB use still reaching 50%-60% in some centers.

To address this, the investigators designed an electronic medical record-based column nudge that flags patients meeting Choosing Wisely criteria for omission of SLNB. This was designed to target surgeons in the moments leading up to the first clinic visit with patients where surgical decision-making is planned. In this study, the investigators deployed the column nudge for a 12 month period.

The enrollment number reflects the number of surgeons participating in the study (whom the nudge was deployed to); it is anticipated this group of surgeons will see over 400 patients between the pre-nudge and post-nudge periods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • early-stage (stages I-III) breast cancer
  • clinically node-negative
  • ER+ and/or PR+, HER2 not-amplified
  • non-metastatic at diagnosis

排除标准

  • under 70 years of age
  • breast cancer is that is not ER+ or PR+

结局指标

主要结局

Rate of SLNB after nudge deployment into the EHR

时间窗: 12 months

We will record the rate of SLNB use (yes/no for if the surgeon performed the surgery) per month over a 12 month intervention period. Rate of SLNB after nudge deployment will be compared to rate of SLNB before nudge deployment.

次要结局

  • Intervention Appropriateness Measure (IAM) [Survey](2 weeks prior to nudge deployment into the EHR)
  • Feasibility of Intervention Measure (FIM) [Survey](2 weeks prior to nudge deployment into the EHR)
  • Acceptability of Intervention (AIM) [Survey](2 weeks prior to nudge deployment into the EHR)

研究者

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

Priscilla McAuliffe

Assistant Professor

University of Pittsburgh Medical Center

研究点 (1)

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