Clinical trial · Observational
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
NCT06006910CI-TRIAL-00074031completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Estrogen-receptor-positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Column-based nudge in the EHR | Behavioral | — | UNRESOLVED |
| No column-based nudge in the EHR | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pre-Nudge Deployment into EHR
- description
- Rates of SLNB will be recorded for the 12 month period prior to nudge deployment.
- interventionNames
- Behavioral: No column-based nudge in the EHR
- label
- Post-Nudge Deployment into EHR
- description
- Rates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR.
- interventionNames
- Behavioral: Column-based nudge in the EHR
Primary outcomes (1)
- measure
- Rate of SLNB after nudge deployment into the EHR
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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+
References
Publications (3)
- BACKGROUNDCarleton 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 35697956
- BACKGROUNDCarleton 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 33856473
- DERIVEDCarleton 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 39018053