- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05383976
Improving Colorectal Cancer Screening in Racially Diverse Zip Codes Using Navigation and Machine Learning (PCSNaP) (PCSNaP)
A Feasibility Study to Improve Colorectal Cancer Screening Among Racially Diverse Zip Codes in a Persistent Poverty County Using Navigation and Machine Learning Predictive Algorithms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specifically, the goals of this study are to: 1) Adapt a previously validated electronic health record (EHR)-based machine learning algorithm to predict colorectal cancer (CRC) detection by retraining the model using data from patients seen in primary care clinics serving zip codes with a high proportion of racial and ethnic minorities living in Philadelphia County, a persistent poverty county; and 2) Implement and evaluate the feasibility and effectiveness of an algorithm-based CRC navigation program to increase colorectal cancer screening among patients in Philadelphia county who are at high risk of CRC and have uncompleted colonoscopies.
Together, these novel projects aim to be the first to combine use of machine learning algorithms and patient navigation to increase guideline-based cancer screening in order to reduce the burden of CRC among high-risk individuals living in a persistent poverty county through targeted, culturally-sensitive navigation that addresses social factors that prevent CRC screening.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices
- Patients who have had a colonoscopy order placed in the past 6 months and have not scheduled, cancelled, or no-showed to their colonoscopy
Exclusion Criteria:
- Not applicable
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients Residing in 18 zip codes in Western and Southwestern Philadelphia
The cohort will consist of patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices.
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This intervention will utilize the existing Penn Medicine CRC patient navigation program.
There will be a monthly list of patients with unfilled coloscopies provided, that are risk-stratified according to the machine learning algorithm and select high-risk criteria.
The navigation team will prioritize timely outreach and navigation to high-risk patients according to a script that communicates risk.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment in Navigator Program (Feasibility)
Time Frame: During the three month enrollment period
|
Number of patients that participate in the navigation program
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During the three month enrollment period
|
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Completion of Colorectal Cancer Screening
Time Frame: Within the three month enrollment period and three month follow-up period
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Number of patients that have completed their colonoscopy or Fecal Immunochemical Test (FIT)
|
Within the three month enrollment period and three month follow-up period
|
|
Number of Participants With Adenoma Detection
Time Frame: Within the three month enrollment period and three month follow-up period
|
Rate of adenomas after completion of colonoscopy
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Within the three month enrollment period and three month follow-up period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carmen Guerra, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 09222
- 850205 (Other Identifier: IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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