Clinical trial NCT06006910: Electronic Medical Record-Based Nudge to Reduce SLNB
Official title: An Electronic Medical Record-Based Nudge Intervention to Reduce Low-Value Axillary Surgery in Older Women With ER+ Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Estrogen-receptor-positive Breast Cancer
Keywords: Sentinel lymph node biopsy
Axillary surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 7
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women 70 years or older with ER+/PR+ and HER2-, early-stage, clinically node negative breast cancer

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.

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+

Primary outcomes:
measure: Rate of SLNB after nudge deployment into the EHR
timeFrame: 12 months
Secondary outcomes:
measure: Acceptability of Intervention (AIM) [Survey]
timeFrame: 2 weeks prior to nudge deployment into the EHR
measure: Intervention Appropriateness Measure (IAM) [Survey]
timeFrame: 2 weeks prior to nudge deployment into the EHR
measure: Feasibility of Intervention Measure (FIM) [Survey]
timeFrame: 2 weeks prior to nudge deployment into the EHR
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Priscilla F McAuliffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.