Breast Cancer, Estrogen-receptor-positive Breast Cancer
Conditions
Keywords
Sentinel lymph node biopsy, Axillary surgery
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.
Interventions
BEHAVIORALColumn-based nudge in the EHR
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.
BEHAVIORALNo column-based nudge in the EHR
No intervention control period prior to nudge deployment.
Sponsors
University of Pittsburgh Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
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+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of SLNB after nudge deployment into the EHR | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention (AIM) [Survey] | 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. |
| Intervention Appropriateness Measure (IAM) [Survey] | 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. |
| Feasibility of Intervention Measure (FIM) [Survey] | 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. |
Countries
United States
Outcome results
None listed