Survey Study on Barrett's Esophagus Screening

Active, not recruiting

• Conditions: Esophagus Adenocarcinoma; Gastroesophageal Reflux Disease; Barrett's Esophagus
• Interventions: Behavioral: Patient Survey; Behavioral: Primary Care Provider Survey; Behavioral: Gastroenterologist Survey

• Registration Number: NCT04408105
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2020-02-19
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Primary Completion: 2021-09-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 725

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Patient Survey	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.
Primary Care Providers	Primary Care Provider Survey	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.
Gastroenterologists	Gastroenterologist Survey	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.

Primary Outcome Measures

Name	Time	Method
To define provider-level knowledge, attitudes, and barriers to BE screening.	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.
To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.	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.

Trial Locations

Locations (7)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Pennsylvania Presbyterian Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Parkland Health and Hospital System; 🇺🇸 Dallas, Texas, United States

Denver Health Medical Center; 🇺🇸 Aurora, Colorado, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States