xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006910</url>
    </required_header>
    <id_info>
      <org_study_id>4040</org_study_id>
      <nct_id>NCT06006910</nct_id>
    </id_info>
    <brief_title>Electronic Medical Record-Based Nudge to Reduce SLNB</brief_title>
    <official_title>An Electronic Medical Record-Based Nudge Intervention to Reduce Low-Value Axillary Surgery in Older Women With ER+ Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pittsburgh</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective, historically-controlled, quality improvement project is to&#xD;
        determine whether and to what extent an electronic health record (EHR)-based nudge affects&#xD;
        rates of sentinel lymph node biopsy (SLNB) in older women with ER+, early-stage, clinically&#xD;
        node negative breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Society of Surgical Oncology (SSO) adopted a series of Choosing Wisely recommendations in an&#xD;
        effort to reduce low-value surgeries. One such recommendation, first released in 2016,&#xD;
        advocates against routine use of sentinel lymph node biopsy (SLNB) for axillary staging in&#xD;
        older women (≥ 70 years old) with early-stage, estrogen receptor positive (ER+), clinically&#xD;
        node-negative breast cancer. Data supporting this recommendation were largely retrospective&#xD;
        in nature as there were no direct randomized trials testing de-escalation of SLNB in this&#xD;
        population of patients. This has led to variability in de-implementation of SLNB, with rates&#xD;
        of SLNB use still reaching 50%-60% in some centers.&#xD;
  &#xD;
        To address this, we designed an electronic medical record-based column nudge that flags&#xD;
        patients meeting Choosing Wisely criteria for omission of SLNB. This was designed to target&#xD;
        surgeons in the moments leading up to the first clinic visit with patients where surgical&#xD;
        decision-making is planned. In a this study, we deployed the column nudge for a 12 month&#xD;
        period.&#xD;
  &#xD;
        The enrollment number reflects the number of surgeons participating in the study (whom the&#xD;
        nudge was deployed to); we anticipate this group of surgeons will see over 400 patients&#xD;
        between the pre-nudge and post-nudge periods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 15, 2022</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of SLNB after nudge deployment into the EHR</measure>
      <time_frame>12 months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Intervention (AIM) [Survey]</measure>
      <time_frame>2 weeks prior to nudge deployment into the EHR</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Appropriateness Measure (IAM) [Survey]</measure>
      <time_frame>2 weeks prior to nudge deployment into the EHR</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of Intervention Measure (FIM) [Survey]</measure>
      <time_frame>2 weeks prior to nudge deployment into the EHR</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Estrogen-receptor-positive Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Pre-Nudge Deployment into EHR</arm_group_label>
      <description>Rates of SLNB will be recorded for the 12 month period prior to nudge deployment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Post-Nudge Deployment into EHR</arm_group_label>
      <description>Rates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Column-based nudge in the EHR</intervention_name>
      <description>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.</description>
      <arm_group_label>Post-Nudge Deployment into EHR</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>No column-based nudge in the EHR</intervention_name>
      <description>No intervention control period prior to nudge deployment.</description>
      <arm_group_label>Pre-Nudge Deployment into EHR</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women 70 years or older with ER+/PR+ and HER2-, early-stage, clinically node negative&#xD;
          breast cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  early-stage (stages I-III) breast cancer&#xD;
  &#xD;
            -  clinically node-negative&#xD;
  &#xD;
            -  ER+ and/or PR+, HER2 not-amplified&#xD;
  &#xD;
            -  non-metastatic at diagnosis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  under 70 years of age&#xD;
  &#xD;
            -  breast cancer is that is not ER+ or PR+&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>70 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Priscilla F McAuliffe, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pittsburgh Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Neil Carleton</last_name>
      <phone>4122661991</phone>
      <email>carletonn2@upmc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Pittsburgh Medical Center</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Neil Carleton</last_name>
        <email>carletonn2@upmc.edu</email>
      </contact>
      <investigator>
        <last_name>Priscilla F McAuliffe, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <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>
      <PMID>35697956</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33856473</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh Medical Center</investigator_affiliation>
      <investigator_full_name>Priscilla McAuliffe</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Sentinel lymph node biopsy</keyword>
    <keyword>Axillary surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006910
  org study id: 4040
  nct id: NCT06006910
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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, we 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 a this study, we 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); we anticipate this group of surgeons will see over 400 patients
        between the pre-nudge and post-nudge periods.
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of SLNB after nudge deployment into the EHR
  time frame: 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.
  measure: Acceptability of Intervention (AIM) [Survey]
  time frame: 2 weeks prior to nudge deployment into the EHR
  description: 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.
  measure: Intervention Appropriateness Measure (IAM) [Survey]
  time frame: 2 weeks prior to nudge deployment into the EHR
  description: 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.
  measure: Feasibility of Intervention Measure (FIM) [Survey]
  time frame: 2 weeks prior to nudge deployment into the EHR
  description: 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.
  arm group label: Pre-Nudge Deployment into EHR
  description: Rates of SLNB will be recorded for the 12 month period prior to nudge deployment.
  arm group label: Post-Nudge Deployment into EHR
  description: Rates of SLNB will be recorded for the 12 month period following nudge deployment into the EHR.
  intervention type: Behavioral
  intervention name: Column-based nudge in the EHR
  description: 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.
  arm group label: Post-Nudge Deployment into EHR
  intervention type: Behavioral
  intervention name: No column-based nudge in the EHR
  description: No intervention control period prior to nudge deployment.
  arm group label: Pre-Nudge Deployment into EHR
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 70 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Priscilla F McAuliffe, MD, PhD
  role: Principal Investigator
  affiliation: University of Pittsburgh Medical Center
  last name: Neil Carleton
  phone: 4122661991
  email: carletonn2@upmc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  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.
  PMID: 35697956
  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.
  PMID: 33856473
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh Medical Center
  investigator full name: Priscilla McAuliffe
  investigator title: Assistant Professor
  mesh term: Breast Neoplasms
  sharing ipd: No