Survey Study on Barrett's Esophagus Screening

Gastroesophageal Reflux Disease Clinical Trial

— SCREEN-BE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04408105
• Other study ID #: 19-3052.cc
• Secondary ID: NCI-2020-13912
• Status: Active, not recruiting
• Start date: February 19, 2020
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 725
• Est. completion date: September 2024
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett's Esophagus
• Esophagus Adenocarcinoma
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	Parkland Health and Hospital System	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Pennsylvania Presbyterian Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define provider-level knowledge, attitudes, and barriers to BE screening.	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
Primary	To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.	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