Survey Study on Barrett's Esophagus Screening (SCREEN-BE)

January 12, 2024 updated by: University of Colorado, Denver

Study of Compliance, Practice Patterns, and Barriers REgarding Established National Screening Programs for Barrett's Esophagus: SCREEN-BE

The goal of this study is to optimize Barrett's Esophagus (BE) screening to reduce the incidence, morbidity, and mortality of Esophageal Adenocarcinoma (EAC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

725

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • Denver Health Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Pennsylvania Presbyterian Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75235
        • Parkland Health and Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  1. We will include patients with a diagnosis of gastroesophageal reflux disease (GERD) who have at least one outpatient clinic visit at a participating site. Patients will be identified through an administrative query of the electronic medical record by ICD-10 codes for GERD (K21.0 and K21.9) as well as through a review of the upcoming clinic schedule. Patients with prior diagnosis of BE/EAC or language other than English will be excluded. Across the 7 sites, we plan to enroll 500 patients.
  2. This study will include PCPs and gastroenterologists at participating sites. Across the 7 participating centers, we plan to enroll 100 gastroenterologists and 400 PCPs.

Description

  1. Patient Eligibility Criteria

    Inclusion Criteria:

    • Patients identified by ICD-10 codes for GERD (K21.0 and K21.9) AND
    • Have had at least one outpatient clinic visit at a participating site

    Exclusion Criteria:

    • Prior diagnosis of BE/EAC
    • Non-English speaking
  2. Provider Eligibility Criteria

Inclusion Criteria:

  • Provider must be a PCP and/or gastroenterologist AND
  • Must be at a participating site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Care Providers
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.
Behavioral: Primary Care Provider Survey
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.
Gastroenterologists
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.
Behavioral: Gastroenterologist Survey
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.
Patients
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.
Behavioral: Patient Survey
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To define provider-level knowledge, attitudes, and barriers to BE screening.
Time Frame: 2 years
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.
2 years
To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

American College of Gastroenterology

Investigators

  • Principal Investigator: Sachin Wani, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Actual)

September 23, 2021

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-3052.cc
  • NCI-2020-13912 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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