Clinical trial NCT04408105: Survey Study on Barrett's Esophagus Screening
Official title: Study of Compliance, Practice Patterns, and Barriers REgarding Established National Screening Programs for Barrett's Esophagus: SCREEN-BE
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2020-05-29
Enrollment: 725
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: To define provider-level knowledge, attitudes, and barriers to BE screening.
timeFrame: 2 years
measure: To characterize the association between patient-level knowledge, attitudes, and barriers regarding BE screening.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Presbyterian Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Sachin Wani, MD
role: PRINCIPAL_INVESTIGATOR
References: