Clinical Trials Directory

Trials / Completed

CompletedNCT06006910

Electronic Medical Record-Based Nudge to Reduce SLNB

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

Status
Completed
Phase
Study type
Observational
Enrollment
7 (actual)
Sponsor
University of Pittsburgh Medical Center · Academic / Other
Sex
Female
Age
70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALColumn-based nudge in the EHRThe 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.
BEHAVIORALNo column-based nudge in the EHRNo intervention control period prior to nudge deployment.

Timeline

Start date
2021-10-15
Primary completion
2023-11-01
Completion
2024-02-12
First posted
2023-08-23
Last updated
2024-02-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06006910. Inclusion in this directory is not an endorsement.