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Survey Study on Barrett's Esophagus Screening

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04408105
Acronym
SCREEN-BE
Enrollment
725
Registered
2020-05-29
Start date
2020-02-19
Completion date
2025-10-01
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease, Barrett's Esophagus, Esophagus Adenocarcinoma

Keywords

Barrett's Esophagus, Upper Endoscopy, Barrett's Esophagus Screening, GERD, Gastroesophageal Reflux Disease, BE, EAC, Esophageal Adenocarcinoma

Brief summary

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

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.

Interventions

BEHAVIORALPrimary 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.

BEHAVIORALGastroenterologist 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.

BEHAVIORALPatient 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.

Sponsors

American College of Gastroenterology
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
To define provider-level knowledge, attitudes, and barriers to BE screening.2 yearsThis 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.
To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.2 yearsThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026