Barrett Esophagus
Conditions
Brief summary
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral. The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
Detailed description
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral. Around 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate. The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
Interventions
DEVICEEsoGuard result
Education slide-set EsoGuard and patient cases including EsoGuard result
Sponsors
Medex15
Lucid Diagnostics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons); 2. Have between 1 to 40 years of post-residency clinical experience within their field of practice; 3. Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral | 1 month | The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases | 1 month | The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases. |
Countries
United States
Participant flow
Recruitment details
97 physicians (participant providers) signed an ICF.
Pre-assignment details
A total of 90 providers completed the control round questionnaire with 6 control cases (total of 540 control cases) and a total of 87 completed the intervention round questionnaire with 6 cases (total of 522 intervention cases).
Participants by arm
| Arm | Count |
|---|---|
| Participating Physicians Participating physicians could be primary care physicians or specialists. | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Participating Physicians | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 90 Participants | — |
| Physician type Primary Care | 68 Participants | — |
| Physician type Specialist | 22 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral
The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases.
Time frame: 1 month
Population: A total of 540 control cases were reviewed by 90 providers, and a total of 522 intervention cases were reviewed by 87 providers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Cases | The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral | 382 Cases |
| Intervention Cases | The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral | 211 Cases |
Secondary
The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases
The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases.
Time frame: 1 month
Population: A total of 90 EsoGuard + control cases were reviewed by 90 providers, and a total of 87 EsoGuard + intervention cases were reviewed by 87 providers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Cases | The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases | 53 Cases |
| Intervention Cases | The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases | 78 Cases |