Survey Study on Barrett's Esophagus Screening

NCT04408105 | Completed DMC

• 2 other identifiers: 19-3052.ccNCI-2020-13912
• Study Type: observational
• Target: 725
• Locations: 1 country
• Sites: 7

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).

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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

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

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

Interventions

Primary Care Provider Survey BEHAVIORAL

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.

Primary Care Providers

Gastroenterologist Survey BEHAVIORAL

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.

Gastroenterologists

Patient Survey BEHAVIORAL

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.

Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Prior diagnosis of BE/EAC
• Non-English speaking
• Provider Eligibility Criteria
• Provider must be a PCP and/or gastroenterologist AND
• Must be at a participating site

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American College of Gastroenterology: collaborator

Study Sites (7)

Denver Health Medical Center

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Kolb JM, Chen M, Tavakkoli A, Gallegos J, O'Hara J, Tarter W, Hochheimer CJ, Golubski B, Kopplin N, Hennessey L, Kalluri A, Devireddy S, Scott FI, Falk GW, Singal AG, Vajravelu RK, Wani S. Patient Knowledge, Risk Perception, and Barriers to Barrett's Esophagus Screening. Am J Gastroenterol. 2023 Apr 1;118(4):615-626. doi: 10.14309/ajg.0000000000002054. Epub 2022 Oct 11.

  PMID: 36219171 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Precancerous Conditions; Neoplasms

Study Officials

• Sachin Wani, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 29, 2020
• Study Start: February 19, 2020
• Primary Completion: September 23, 2021
• Study Completion: October 1, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)