<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/NCT04408105</url>
  </required_header>
  <id_info>
    <org_study_id>19-3052.cc</org_study_id>
    <secondary_id>NCI-2020-13912</secondary_id>
    <nct_id>NCT04408105</nct_id>
  </id_info>
  <brief_title>Survey Study on Barrett's Esophagus Screening</brief_title>
  <acronym>SCREEN-BE</acronym>
  <official_title>Study of Compliance, Practice Patterns, and Barriers REgarding Established National Screening Programs for Barrett's Esophagus: SCREEN-BE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Gastroenterology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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 study is to optimize Barrett's Esophagus (BE) screening to reduce the&#xD;
      incidence, morbidity, and mortality of Esophageal Adenocarcinoma (EAC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The initial step to achieve this goal is to study shortcomings of the current BE screening&#xD;
      referral processes in the United States. These shortcomings will be identified through&#xD;
      completion of two synergistic aims that assess:, (1) provider knowledge, attitudes, and&#xD;
      barriers to BE screening referral and (2) patient knowledge, attitudes, and barriers to&#xD;
      completion of BE screening. The central hypothesis is that there are patient- and&#xD;
      provider-level factors that can be modified to improve BE screening adherence. This&#xD;
      hypothesis was formulated based on strong preliminary data demonstrating significant&#xD;
      single-mindedness among gastroenterologists regarding BE screening criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 19, 2020</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Actual">September 23, 2021</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>To define provider-level knowledge, attitudes, and barriers to BE screening.</measure>
    <time_frame>2 years</time_frame>
    <description>This investigator will conduct a survey study among primary care providers and gastroenterologists at 7 large health systems in the U.S.-including 4 tertiary care referral centers and 3 safety-net health systems. Based on constructs from Social Cognitive Theory and Theory of Reasoned Action, the survey will assess provider knowledge, attitudes, and barriers to BE screening among at-risk individuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.</measure>
    <time_frame>2 years</time_frame>
    <description>This investigator will conduct a survey study among patients at 7 large health systems in the U.S. Based on constructs from the Health Behavior Framework, the survey will assess patient knowledge, attitudes, and barriers to BE screening. To accomplish these study aims, this investigator has assembled a strong and diverse team with complementary areas of expertise in Barrett's esophagus, and survey research.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">725</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <condition>Barrett's Esophagus</condition>
  <condition>Esophagus Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Primary Care Providers</arm_group_label>
    <description>400 eligible primary care providers (PCPs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible PCPs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for providers to complete a paper survey at PCP clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastroenterologists</arm_group_label>
    <description>100 eligible gastroenterologists (GIs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible GIs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for GIs to complete a paper survey at provider clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>500 eligible patients will be recruited across the 7 participating sites to complete a survey. The survey will be distributed to eligible patients at the time of a clinic appointment, via telephone, or via a REDCap internet survey that will allow for 2 additional electronic phone call reminders and 1 email reminder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Primary Care Provider Survey</intervention_name>
    <description>To assess PCP demographics, attitudes, and perceived barriers to BE screening, we have developed a PCP survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess PCP knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 PCPs.</description>
    <arm_group_label>Primary Care Providers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gastroenterologist Survey</intervention_name>
    <description>To assess GI demographics, attitudes, and perceived barriers to BE screening, we have developed a GI survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess GI knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 GIs.</description>
    <arm_group_label>Gastroenterologists</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Survey</intervention_name>
    <description>To assess patient knowledge, attitudes, and barriers to completion of BE screening, we will use a theoretical model of patient behavior on the Health Behavior Framework to guide selection of relevant variables for survey development including 4 domains: knowledge about BE and EAC, potential barriers to BE screening completion, patient attitudes and demographic information. Prior to distribution, the survey will be refined and pretested among a sample of 10 patients with each participant completing a cognitive interview prior to distribution.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. We will include patients with a diagnosis of gastroesophageal reflux disease (GERD)&#xD;
             who have at least one outpatient clinic visit at a participating site. Patients will&#xD;
             be identified through an administrative query of the electronic medical record by&#xD;
             ICD-10 codes for GERD (K21.0 and K21.9) as well as through a review of the upcoming&#xD;
             clinic schedule. Patients with prior diagnosis of BE/EAC or language other than&#xD;
             English will be excluded. Across the 7 sites, we plan to enroll 500 patients.&#xD;
&#xD;
          2. This study will include PCPs and gastroenterologists at participating sites. Across&#xD;
             the 7 participating centers, we plan to enroll 100 gastroenterologists and 400 PCPs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Patient Eligibility Criteria&#xD;
&#xD;
             Inclusion Criteria:&#xD;
&#xD;
               -  Patients identified by ICD-10 codes for GERD (K21.0 and K21.9) AND&#xD;
&#xD;
               -  Have had at least one outpatient clinic visit at a participating site&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  Prior diagnosis of BE/EAC&#xD;
&#xD;
               -  Non-English speaking&#xD;
&#xD;
          2. Provider Eligibility Criteria&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Provider must be a PCP and/or gastroenterologist AND&#xD;
&#xD;
          -  Must be at a participating site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sachin Wani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Presbyterian Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health and Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Barrett's Esophagus</keyword>
  <keyword>Upper Endoscopy</keyword>
  <keyword>Barrett's Esophagus Screening</keyword>
  <keyword>GERD</keyword>
  <keyword>Gastroesophageal Reflux Disease</keyword>
  <keyword>BE</keyword>
  <keyword>EAC</keyword>
  <keyword>Esophageal Adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04408105
org study id: 19-3052.cc
secondary id: NCI-2020-13912
nct id: NCT04408105
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to optimize Barrett's Esophagus (BE) screening to reduce the
      incidence, morbidity, and mortality of Esophageal Adenocarcinoma (EAC).
The initial step to achieve this goal is to study shortcomings of the current BE screening
      referral processes in the United States. These shortcomings will be identified through
      completion of two synergistic aims that assess:, (1) provider knowledge, attitudes, and
      barriers to BE screening referral and (2) patient knowledge, attitudes, and barriers to
      completion of BE screening. The central hypothesis is that there are patient- and
      provider-level factors that can be modified to improve BE screening adherence. This
      hypothesis was formulated based on strong preliminary data demonstrating significant
      single-mindedness among gastroenterologists regarding BE screening criteria.
observational model: Cohort
time perspective: Prospective
measure: To define provider-level knowledge, attitudes, and barriers to BE screening.
time frame: 2 years
description: This investigator will conduct a survey study among primary care providers and gastroenterologists at 7 large health systems in the U.S.-including 4 tertiary care referral centers and 3 safety-net health systems. Based on constructs from Social Cognitive Theory and Theory of Reasoned Action, the survey will assess provider knowledge, attitudes, and barriers to BE screening among at-risk individuals.
measure: To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.
time frame: 2 years
description: This investigator will conduct a survey study among patients at 7 large health systems in the U.S. Based on constructs from the Health Behavior Framework, the survey will assess patient knowledge, attitudes, and barriers to BE screening. To accomplish these study aims, this investigator has assembled a strong and diverse team with complementary areas of expertise in Barrett's esophagus, and survey research.
arm group label: Primary Care Providers
description: 400 eligible primary care providers (PCPs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible PCPs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for providers to complete a paper survey at PCP clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.
arm group label: Gastroenterologists
description: 100 eligible gastroenterologists (GIs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible GIs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for GIs to complete a paper survey at provider clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.
arm group label: Patients
description: 500 eligible patients will be recruited across the 7 participating sites to complete a survey. The survey will be distributed to eligible patients at the time of a clinic appointment, via telephone, or via a REDCap internet survey that will allow for 2 additional electronic phone call reminders and 1 email reminder.
intervention type: Behavioral
intervention name: Primary Care Provider Survey
description: To assess PCP demographics, attitudes, and perceived barriers to BE screening, we have developed a PCP survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess PCP knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 PCPs.
arm group label: Primary Care Providers
intervention type: Behavioral
intervention name: Gastroenterologist Survey
description: To assess GI demographics, attitudes, and perceived barriers to BE screening, we have developed a GI survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess GI knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 GIs.
arm group label: Gastroenterologists
intervention type: Behavioral
intervention name: Patient Survey
description: To assess patient knowledge, attitudes, and barriers to completion of BE screening, we will use a theoretical model of patient behavior on the Health Behavior Framework to guide selection of relevant variables for survey development including 4 domains: knowledge about BE and EAC, potential barriers to BE screening completion, patient attitudes and demographic information. Prior to distribution, the survey will be refined and pretested among a sample of 10 patients with each participant completing a cognitive interview prior to distribution.
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sachin Wani, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Barrett Esophagus
mesh term: Gastroesophageal Reflux
sharing ipd: No