Enhancing Screening Practices for BE
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Previous studies have shown that screening for Barrett's esophagus (BE), the main risk factor for esophageal adenocarcinoma, is under-utilized in the primary care setting. In fact less than 35% of eligible patients are screened despite endorsement for screening by the major GI societies in patients with risk factors. The purpose of this study is to examine current screening practices and determine if implementation of screening reminders can optimize screening practices for Barrett's Esophagus within a large, academic based healthcare system in NJ.
Full description
Barrett's esophagus (BE) is a pre-malignant mucosal transformation of the distal esophageal mucosal lining whereby the metaplastic columnar epithelium replaces squamous epithelium of the esophagus. BE is the main risk factor to develop esophageal adenocarcinoma. The etiology of BE is complex and likely multifactorial, with several factors including gastrointestinal reflux (GERD), genetic factors, environmental triggers, immunoregulatory defects playing a role. It is well known that the transformation of cells lining the distal esophagus is due to chronic repeated insults by longstanding GERD.
A significant proportion of patients diagnosed with BE are discovered during endoscopic evaluation of middle-aged and older adults however a majority of cases are unrecognized. The vast majority of patients (up to 90%) with EAC have never had a diagnosis of BE. A major limitation of BE screening are those individuals with silent or asymptomatic GERD. In a study evaluating the sensitivity of guidelines by determining the proportion of prevalent EAC that met screening criteria for BE by American College of Gastroenterology (ACG) or the British Society of Gastroenterology (BSG) guidelines, 54.9% of the US patients and 38.9% of the UK patients would not have been identified by current screening guidelines. Furthermore, the reason most patients (US, 86.5%; UK, 61.4%) did not meet screening guidelines was the lack of symptomatic GERD.
Currently, upper endoscopy with biopsies remains the gold standard for the diagnosis of BE however there is a significant need for other, non-invasive screening tools that are easy to implement, cost-friendly, and patient friendly. Other options include trans-nasal endoscopy and non-endoscopic cell collection devices which can be used in the outpatient setting and avoids need for sedation. Trans-nasal endoscopy remains costly, operator-dependent, and uncomfortable or distressing to patients. Current non-endoscopic cell collection devices include Cytosponge (Medtronic GI Solutions), EsoCheck (Lucid Diagnostics), and EsophaCap (Capnostics) which have demonstrated excellent safety, tolerability, and sensitivity for the diagnosis of BE. Nonendoscopic devices are currently an approved method of screening per the 2022 American College of Gastroenterology (ACG) society guidelines on diagnosis of BE.
The presence of metabolic disease increases the risk of developing cancer. Early studies suggested the presence of metabolic syndrome and visceral fat (eg, MASLD, pancreatic fatty infiltration) are associated with BE and typically portray higher risk for progression to dysplasia or neoplasia. Current standard is EGD for screening of BE and surveillance determined by histology and length of mucosal changes. The role of evaluation for visceral adiposity, either via cross-sectional imaging or endoscopic ultrasound, has not been elucidated. Factoring visceral adiposity may allow the investigators to risk-stratify patients for screening or optimize surveillance strategies to prevent progression to EAC.
This is a single center randomized controlled trial examining whether implementation of screening reminders for eligible patients will increase BE screening rates. The investigators will enroll 8 practices (see below) in the New Brunswick area. 4 practices will be randomized to the screening reminder arm and 4 practices will be randomized to the no reminder screening arm. In each arm baseline data will be collected on BE screening rates for the practice prior to the study for comparison.
The screening reminder arm will undergo the following. Patient's medical charts will be screened via epic to determine if patients meet criteria for BE screening per the ACG (American College of Gastroenterology) or ASGE (American Society of GI Endoscopy) guidelines. Charts will be screened by a gastroenterology fellow on the study team or a gastroenterology attending on the study team. If patients qualify for screening, the provider will receive an email and Epic chat the day before the patient's office appointment with the provider letting them know which patients on their panel qualify for screening for BE.
Providers in both arms of the study will be notified of GI services to help screen patients for BE prior the study inception, including referral to GI clinic for nonendoscopic screening.
BE screening is part of standard of care for patients who meet criteria, as defined by ACG/ASGE guidelines. Sending reminders to primary care offices/staff is not standard of care. The 8 practices are affiliated with RWJ Barnabas Health Medical group. Reminders (email or Epic chat) will be sent the day before the patient's scheduled appointment with the provider. Data regarding demographics, comorbidities, and presence of other factors that qualify patients into BE screening will be recorded. The investigators will then record which patients were or were not screened for BE with either invasive (eg, EGD) or non-invasive measures.
Enrollment
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Inclusion criteria
- 18 years of age or older
- Have a scheduled appointment with a participating provider
Exclusion criteria
- Less than 18 years of age
Trial design
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Interventional model
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3,000 participants in 2 patient groups
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Central trial contact
Molly Stewart
Data sourced from clinicaltrials.gov
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