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Completed

NCT Number: NCT06006910

Electronic Medical Record-Based Nudge to Reduce SLNB

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.

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Key information

Age range

70 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

Column-based nudge in the EHR

Behavioral

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.

No column-based nudge in the EHR

Behavioral

No intervention control period prior to nudge deployment.

Primary outcomes

  1. 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

  1. Acceptability of Intervention (AIM) [Survey]

    Time frame: 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.

  2. Intervention Appropriateness Measure (IAM) [Survey]

    Time frame: 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.

  3. Feasibility of Intervention Measure (FIM) [Survey]

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 23, 2023
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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