Clinician Decision Making Regarding Surveillance For Low-risk Intraductal Papillary Mucinous Neoplasms Of The Pancreas

Study Overview

Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas

The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.

The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. This will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.

Surgery Risk Assessment

22-01227

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-08
First Submitted that Met QC Criteria 2024-03-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-15
First Posted (ACTUAL) 2024-03-15	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Vignettes with Risk Stratification Tool Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Particip
: Vignettes without Risk Stratification Tool Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Particip

Primary Outcome Measures	Measure Description	Time Frame
Number of Decisions to Stop Surveillance Imaging		Day 1
Number of Decisions to Continue Surveillance Imaging		Day 1

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Membership in either the PACYFIC or PRECEDE consortiums
Physician with expertise in the management of IPMN
Able and willing to complete survey

Not a member of either the PACYFIC or PRECEDE consortiums
Not a physician with expertise in the management of IPMN

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Greg Sacks, MD, MPH, PhD, NYU Langone Health

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record