Electronic Medical Record-Based Nudge to Reduce SLNB

Study Overview
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Brief Summary
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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.

Detailed Description
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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, we 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 a this study, we 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); we anticipate this group of surgeons will see over 400 patients between the pre-nudge and post-nudge periods.

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

Conditions
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Breast Cancer, Estrogen-receptor-positive Breast Cancer

Intervention / Treatment
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* Behavioral: Column-based nudge in the EHR
* Behavioral: No column-based nudge in the EHR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: early-stage (stages I-III) breast cancer clinically node-negative ER+ and/or PR+, HER2 not-amplified non-metastatic at diagnosis Exclusion Criteria: under 70 years of age breast cancer is that is not ER+ or PR+

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Nudge Deployment into EHR<br>Rates of SLNB will be recorded for the 12 month period prior to nudge deployment. | Behavioral: No column-based nudge in the EHR<br>* No intervention control period prior to nudge deployment.<br>|
| Post-Nudge Deployment into EHR<br>Rates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR. | Behavioral: Column-based nudge in the EHR<br>* The nudge is a column in EPIC that flags patients coming to the clinic as a new visit with documented ER+ breast cancer. The nudge flag can pop up when hovered over to remind surgeons of the Choosing Wisely criteria and to consider omission of SLNB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of SLNB after nudge deployment into the EHR | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention (AIM) [Survey] | AIM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree [1] - Completely Agree [5]), scored as a mean. The median score across all participants will be reported. | 2 weeks prior to nudge deployment into the EHR | 
| Intervention Appropriateness Measure (IAM) [Survey] | AIM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree [1] - Completely Agree [5]), scored as a mean. The median score across all participants will be reported. | 2 weeks prior to nudge deployment into the EHR | 
| Feasibility of Intervention Measure (FIM) [Survey] | AIM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree [1] - Completely Agree [5]), scored as a mean. The median score across all participants will be reported. | 2 weeks prior to nudge deployment into the EHR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node biopsy, Axillary surgery