Electronic Medical Record-Based Nudge to Reduce SLNB

Completed

• Conditions: Breast Cancer; Estrogen-receptor-positive Breast Cancer
• Interventions: Behavioral: Column-based nudge in the EHR; Behavioral: No column-based nudge in the EHR

• Registration Number: NCT06006910
• Lead Sponsor: University of Pittsburgh Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Primary Completion: 2023-11-01
• Status Verified: 2024-02
• Study Completion: 2024-02-12
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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+

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Nudge Deployment into EHR	Column-based nudge in the EHR	Rates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR.
Pre-Nudge Deployment into EHR	No column-based nudge in the EHR	Rates of SLNB will be recorded for the 12 month period prior to nudge deployment.

Primary Outcome Measures

Name	Time	Method
Rate of SLNB after nudge deployment into the EHR	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States