SCREEN-BE: Survey Study on Barrett's Esophagus Screening

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04408105

Collaborator

American College of Gastroenterology (Other)

1,000

Enrollment

Locations

30.4

Anticipated Duration (Months)

142.9

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Barrett's Esophagus Esophagus Adenocarcinoma	Behavioral: Primary Care Provider Survey Behavioral: Gastroenterologist Survey Behavioral: Patient Survey

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 19, 2020

Actual Primary Completion Date :

Sep 23, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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.
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 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.
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 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.

Arm

Intervention/Treatment

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

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.

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

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.

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

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Provider Eligibility Criteria

Inclusion Criteria:

Provider must be a PCP and/or gastroenterologist AND
Must be at a participating site

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Health Medical Center	Aurora	Colorado	United States	80045
2	University of Colorado Hospital	Aurora	Colorado	United States	80045
3	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
4	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19104
5	Pennsylvania Presbyterian Hospital	Philadelphia	Pennsylvania	United States	19104
6	Parkland Health and Hospital System	Dallas	Texas	United States	75235
7	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390