Clinical Utility Study for Exo-PDAC

NCT05702385 | Withdrawn

• 1 other identifier: Pro00068105
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (6)

• Clinical Performance and Value (CPV)-measured variation in Assessment

  Measure variation in the number and quality of clinical decisions among practicing oncologists, primary care physicians, and interventional gastroenterologists in the assessment, surveillance, and management of patients at high risk of developing PDAC. The number and quality of clinical decisions will be measured on a scale of 0-100 where higher numbers represent closer adherence to evidence base national guidelines.

  [4 months]

• CPV-measured change in treatment Quality

  Measure of the difference in quality of overall diagnostic scores between control physicians using standard of care diagnostic tools and intervention physicians using the diagnostic test.

  [4 months]

• CPV-measured variation in evidence based decisions between control and intervention arms

  Measure of the difference in number of evidence-based decisions made by intervention physicians versus control physicians, while controlling for physician and practice characteristics, between rounds 1 and 2.

  [4 months]

• CPV-measured variation in evidence based decisions between intervention arms

  Measure the differences in amount of evidence-based decisions made by intervention group one physicians versus intervention group two physicians to assess whether the choice to order the test impacts the overall patient care and outcomes.

  [4 months]

• CPV-measured rate of adoption for the diagnostic test

  Rate of adoption of the test after receiving educational materials on the benefits of testing in patients who are at risk.

  [4 months]

• CPV-measured differences in cost of care between control and intervention arms

  Difference in the cost of care between control and intervention physicians (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs per above).

  [4 months]

Study Arms (3)

Standard Practice

NO INTERVENTION

The control group treats their simulated patients using standard practice and has no introduction to the new diagnostic test.

Intervention Group 1 - Test Results Given

EXPERIMENTAL

Intervention Group 1 will receive information regarding the test and will be given the test results, whether selected or not, in Round 2 of CPV administration.

Other: Educational Materials for a new diagnostic test

Intervention Group 2 - Test Results Optional

EXPERIMENTAL

Intervention Group 2 will receive information regarding the test and will be given the test results if selected in Round 2 of CPV administration.

Other: Educational Materials for a new diagnostic test

Interventions

Educational Materials for a new diagnostic test OTHER

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.

Intervention Group 1 - Test Results Given; Intervention Group 2 - Test Results Optional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Board-certified for at least two years
• Averaging at least 20 hours per week of clinical and patient care duties over the last six months
• Routinely evaluate patients at risk for pancreatic cancer in their practice
• Practicing in the U.S.
• English speaking
• Access to the internet
• Informed, signed, and voluntarily consented to be in the study

You may not qualify if:

• Non-English speaking
• Unable to access the internet
• Not practicing in the U.S.
• Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
• Previous exposure to the test
• Do not voluntarily consent to be in the study

Sponsors & Collaborators

• Qure Healthcare, LLC: lead

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll oncologists, interventional gastroenterologists, and primary care providers practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. Intervention 1 and intervention 2 arms only will receive educational material about the diagnostic test in between these two rounds. Intervention 1 arm participants only will receive the test results whether they select it or not, and Intervention 2 participants will receive the test results only if they select it in the second round of simulated cases

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: September 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

US (1)