An Electronic Medical Record-Based Nudge Intervention to Reduce Low-Value Axillary Surgery in Older Women With ER+ Breast Cancer
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
- 否
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
Priscilla McAuliffe
Assistant Professor
University of Pittsburgh Medical Center
