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Clinical Utility Evidence for TissueCypher®

Primary Purpose

Gastro-Intestinal Disorder, Barrett Esophagus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational materials for TissueCypher
Sponsored by
Qure Healthcare, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastro-Intestinal Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Board-certified gastroenterologist or GI surgeon for at least two years
  • Averages at least 20 hours per week of clinical and patient care duties over the last six months
  • performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
  • practicing in the US
  • english speaking
  • access to the internet
  • informed and voluntarily consented to be in the study

Exclusion Criteria:

  • non-English speaking
  • unable to access the internet
  • not practicing in the US
  • not averaging at least 20 hours per week of clinical or patient care duties over the last six months
  • does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
  • does not voluntarily consent to be in the study

Sites / Locations

  • QURE Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Intervention Group 1

Intervention Group 2

Arm Description

The control group does not receive educational materials about the TissueCypher diagnostic test and will treat their simulated patients with the current standard of care tools.

Intervention group 1 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group is then forced to use the test results in treating their simulated patients.

Intervention group 2 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group then gets to decide whether or not they want to use the TissueCypher test results for their simulated patients.

Outcomes

Primary Outcome Measures

Clinical Performance and Value (CPV)-measured change in physician behavior
Change in the overall and the diagnostic and treatment evidence-based quality scores in the CPV patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes.
CPV-measured evidence based management decisions
Evidence-based management decisions based on patient's TissueCypher® test result: Once the intervention group is exposed to the intervention, education materials on the TissueCypher (a validated diagnostic test for predicting risk progression of BE patients), the scores are measured, on a scale of 0% to 100% from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the evidence-based TissueCypher results influence physicians' management decisions.
CPV-measured cost savings
Change in cost of BE-related care. (This cost is modeled in part by measuring differential rates of endoscopic work up/interventions/levels of care selected by each arm, and multiplying by average Medicare reimbursement rates for these workups/interventions/levels of care. The cost is also modeled by examining average per annum costs for patients suffering from BE, and multiplying by the percent of patients whose workup or therapeutic management is significantly reduced following the intervention.)

Secondary Outcome Measures

CPV-measured baseline levels of variation
Participants completing the simulated cases, or CPVs, receive scores, on a scale from 0% to 100%, based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types. Baseline levels of variation will be measured in the surveillance, management and treatment of patients with Barrett's esophagus among all participants
CPV-measured use case analysis
Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is an average score of the subcategory scores (percent correct). The score is reported on a scale from 0% to 100%. This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.

Full Information

First Posted
December 9, 2021
Last Updated
September 6, 2022
Sponsor
Qure Healthcare, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05200325
Brief Title
Clinical Utility Evidence for TissueCypher®
Official Title
Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for TissueCypher®: A CPV® Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qure Healthcare, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Disorder, Barrett Esophagus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participants, who are care providers, do not know what study arm they are included in.
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group does not receive educational materials about the TissueCypher diagnostic test and will treat their simulated patients with the current standard of care tools.
Arm Title
Intervention Group 1
Arm Type
Experimental
Arm Description
Intervention group 1 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group is then forced to use the test results in treating their simulated patients.
Arm Title
Intervention Group 2
Arm Type
Experimental
Arm Description
Intervention group 2 receives educational materials about the TissueCypher diagnostic test. These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. This intervention group then gets to decide whether or not they want to use the TissueCypher test results for their simulated patients.
Intervention Type
Other
Intervention Name(s)
Educational materials for TissueCypher
Intervention Description
These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.
Primary Outcome Measure Information:
Title
Clinical Performance and Value (CPV)-measured change in physician behavior
Description
Change in the overall and the diagnostic and treatment evidence-based quality scores in the CPV patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes.
Time Frame
4 months
Title
CPV-measured evidence based management decisions
Description
Evidence-based management decisions based on patient's TissueCypher® test result: Once the intervention group is exposed to the intervention, education materials on the TissueCypher (a validated diagnostic test for predicting risk progression of BE patients), the scores are measured, on a scale of 0% to 100% from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the evidence-based TissueCypher results influence physicians' management decisions.
Time Frame
4 months
Title
CPV-measured cost savings
Description
Change in cost of BE-related care. (This cost is modeled in part by measuring differential rates of endoscopic work up/interventions/levels of care selected by each arm, and multiplying by average Medicare reimbursement rates for these workups/interventions/levels of care. The cost is also modeled by examining average per annum costs for patients suffering from BE, and multiplying by the percent of patients whose workup or therapeutic management is significantly reduced following the intervention.)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
CPV-measured baseline levels of variation
Description
Participants completing the simulated cases, or CPVs, receive scores, on a scale from 0% to 100%, based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types. Baseline levels of variation will be measured in the surveillance, management and treatment of patients with Barrett's esophagus among all participants
Time Frame
4 months
Title
CPV-measured use case analysis
Description
Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is an average score of the subcategory scores (percent correct). The score is reported on a scale from 0% to 100%. This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Board-certified gastroenterologist or GI surgeon for at least two years Averages at least 20 hours per week of clinical and patient care duties over the last six months performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery practicing in the US english speaking access to the internet informed and voluntarily consented to be in the study Exclusion Criteria: non-English speaking unable to access the internet not practicing in the US not averaging at least 20 hours per week of clinical or patient care duties over the last six months does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery does not voluntarily consent to be in the study
Facility Information:
Facility Name
QURE Healthcare
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Utility Evidence for TissueCypher®

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