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Clinical Trials/NCT06006910
NCT06006910
Completed
Not Applicable

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 site in 1 country7 target enrollmentOctober 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Pittsburgh Medical Center
Enrollment
7
Locations
1
Primary Endpoint
Rate of SLNB after nudge deployment into the EHR
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
February 12, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Priscilla McAuliffe

Assistant Professor

University of Pittsburgh Medical Center

Eligibility Criteria

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+

Outcomes

Primary Outcomes

Rate of SLNB after nudge deployment into the EHR

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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