NCT06006910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

August 17, 2023

Last Update Submit

February 12, 2024

Conditions

Breast CancerEstrogen-receptor-positive Breast Cancer

Keywords

Sentinel lymph node biopsyAxillary surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Acceptability of Intervention (AIM) [Survey]

    2 weeks prior to nudge deployment into the EHR

  • 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

Study Arms (2)

Pre-Nudge Deployment into EHR

Rates of SLNB will be recorded for the 12 month period prior to nudge deployment.

Behavioral: No column-based nudge in the EHR

Post-Nudge Deployment into EHR

Rates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR.

Behavioral: Column-based nudge in the EHR

Interventions

Column-based nudge in the EHRBEHAVIORAL

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.

Post-Nudge Deployment into EHR
No column-based nudge in the EHRBEHAVIORAL

No intervention control period prior to nudge deployment.

Pre-Nudge Deployment into EHR

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Women 70 years or older with ER+/PR+ and HER2-, early-stage, clinically node negative breast cancer

You may qualify if:

  • early-stage (stages I-III) breast cancer
  • clinically node-negative
  • ER+ and/or PR+, HER2 not-amplified
  • non-metastatic at diagnosis

You may not qualify if:

  • under 70 years of age
  • breast cancer is that is not ER+ or PR+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • Carleton N, Oesterreich S, Marroquin OC, Diego EJ, Tseng GC, Lee AV, McAuliffe PF. Is the Choosing Wisely Recommendation for Omission of Sentinel Lymph Node Biopsy Applicable for Invasive Lobular Carcinoma? Ann Surg Oncol. 2022 Sep;29(9):5379-5382. doi: 10.1245/s10434-022-12003-3. Epub 2022 Jun 13. No abstract available.

    PMID: 35697956BACKGROUND

  • Carleton N, Zou J, Fang Y, Koscumb SE, Shah OS, Chen F, Beriwal S, Diego EJ, Brufsky AM, Oesterreich S, Shapiro SD, Ferris R, Emens LA, Tseng G, Marroquin OC, Lee AV, McAuliffe PF. Outcomes After Sentinel Lymph Node Biopsy and Radiotherapy in Older Women With Early-Stage, Estrogen Receptor-Positive Breast Cancer. JAMA Netw Open. 2021 Apr 1;4(4):e216322. doi: 10.1001/jamanetworkopen.2021.6322.

    PMID: 33856473BACKGROUND

  • Carleton N, Radomski TR, Li D, Zou J, Harris J, Hamm M, Wang Z, Saadawi G, Fischer GS, Arnold J, Cowher MS, Lupinacci K, Sabih Q, Steiman J, Johnson RR, Soran A, Diego EJ, Oesterreich S, Tseng G, Lee AV, McAuliffe PF. Electronic Health Record-Based Nudge Intervention and Axillary Surgery in Older Women With Breast Cancer: A Nonrandomized Controlled Trial. JAMA Surg. 2024 Oct 1;159(10):1117-1125. doi: 10.1001/jamasurg.2024.2407.

    PMID: 39018053DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Priscilla F McAuliffe, MD, PhD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

October 15, 2021

Primary Completion

November 1, 2023

Study Completion

February 12, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)