Breast CancerNCT06006910
Electronic Medical Record-Based Nudge to Reduce SLNB
An observational study of Breast Cancer and Estrogen-receptor-positive Breast Cancer, run by University of Pittsburgh Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer, Estrogen-receptor-positive Breast Cancer
- What is being tested?
- Column-based nudge in the EHR and No column-based nudge in the EHR
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 12 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Women 70 years or older with ER+/PR+ and HER2-, early-stage, clinically node negative breast cancer
Who may be able to join
- early-stage (stages I-III) breast cancer
- clinically node-negative
- ER+ and/or PR+, HER2 not-amplified
- non-metastatic at diagnosis
Who cannot join
- under 70 years of age
- breast cancer is that is not ER+ or PR+
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Electronic Medical Record-Based Nudge Intervention to Reduce Low-Value Axillary Surgery in Older Women With ER+ Breast Cancer
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.
Read the 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.
- Being tested
- Column-based nudge in the EHR, No column-based nudge in the EHR
- Keywords
- Sentinel lymph node biopsy, Axillary surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Column-based nudge in the EHRBehavioural
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 EHRBehavioural
No intervention control period prior to nudge deployment.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Nudge Deployment into EHR | Rates of SLNB will be recorded for the 12 month period prior to nudge deployment. Receives: 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. Receives: Behavioral: Column-based nudge in the EHR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Acceptability of Intervention (AIM) [Survey]
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.
Measured: 2 weeks prior to nudge deployment into the EHR
Intervention Appropriateness Measure (IAM) [Survey]
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.
Measured: 2 weeks prior to nudge deployment into the EHR
Feasibility of Intervention Measure (FIM) [Survey]
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.
Measured: 2 weeks prior to nudge deployment into the EHR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start15 Oct 2021
- Primary completion1 Nov 2023
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscilla McAuliffe, University of Pittsburgh Medical Center
- Investigators
- Priscilla F McAuliffe, MD, PhD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006910
- Sponsor's protocol ID
- 4040
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35697956Carleton 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.
PubMed 33856473Carleton 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.
PubMed 39018053
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electronic Medical Record-Based Nudge Intervention to Reduce Low-Value Axillary Surgery in Older Women With ER+ Breast Cancer
- ClinicalTrials.gov ID
- NCT06006910
- Acronym / sponsor ID
- 4040
- Keywords
- Sentinel lymph node biopsy, Axillary surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Pittsburgh Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Nudge Deployment into EHR | – | Behavioral: No column-based nudge in the EHRRates of SLNB will be recorded for the 12 month period prior to nudge deployment. |
| Post-Nudge Deployment into EHR | – | Behavioral: Column-based nudge in the EHRRates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Women 70 years or older with ER+/PR+ and HER2-, early-stage, clinically node negative breast cancer
Key inclusion criteria (4 listed)
- early-stage (stages I-III) breast cancer
- clinically node-negative
- ER+ and/or PR+, HER2 not-amplified
- non-metastatic at diagnosis
Key exclusion criteria (2 listed)
- under 70 years of age
- breast cancer is that is not ER+ or PR+
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Column-based nudge in the EHRThe 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. | Behavioural | Post-Nudge Deployment into EHR |
| No column-based nudge in the EHRNo intervention control period prior to nudge deployment. | Behavioural | Pre-Nudge Deployment into EHR |
Primary outcome
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.
3 secondary outcomes
Acceptability of Intervention (AIM) [Survey]
Time frame: 2 weeks prior to nudge deployment into the EHR
Intervention Appropriateness Measure (IAM) [Survey]
Time frame: 2 weeks prior to nudge deployment into the EHR
Feasibility of Intervention Measure (FIM) [Survey]
Time frame: 2 weeks prior to nudge deployment into the EHR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 35697956Carleton 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.
- Background: PubMed 33856473Carleton 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.
- Derived from this study: PubMed 39018053Carleton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priscilla F McAuliffe, MD, PhD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Estrogen-receptor-positive Breast Cancer, run by University of Pittsburgh Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SLNB after nudge deployment into the EHR (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006910, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.