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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05383976
Collaborator
(none)
150
1
5
29.8

Study Details

Study Description

Brief Summary

The overarching goals of the "PCSNaP" Research Study is to support the Abramson Cancer Center (ACC) of the University of Pennsylvania in carrying out its mission to increase colorectal cancer (CRC) screening completion among high-risk individuals living in a persistent poverty county by designing, conducting, disseminating and evaluating an electronic health record-based automated identification program to target effective, culturally-sensitive CRC screening navigation to individuals who have not completed an ordered colonoscopy or fecal immunochemical test (FIT).

Condition or Disease Intervention/Treatment Phase
  • Other: Machine Learning Algorithm with Existing Penn Medicine CRC Patient Navigation Program

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Other: Machine Learning Algorithm with Existing Penn Medicine CRC Patient Navigation Program
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.

Outcome Measures

Primary Outcome Measures

  1. Enrollment in Navigator Program (Feasibility) [During the three month enrollment period]

    Number of patients that participate in the navigation program

  2. Completion of Colonoscopy [Within the three month enrollment period and three month follow-up period]

    Number of patients that have completed their colonoscopy

  3. Adenoma Detection Rate [Within the three month enrollment period and three month follow-up period]

    Rate of adenomas after completion of colonoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Ravi Parikh, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ravi Parikh, Principle Investigator, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05383976
Other Study ID Numbers:
  • 850205
First Posted:
May 20, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022