Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401174
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-06
First Post:
2024-04-22
Brief Title:
Patient Navigation for Colorectal Cancer Screening
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Bridging the Gap Delivering Equitable Colorectal Cancer Screening
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCREEN
Brief Summary:
Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities but there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices The investigators will conduct a stepped-wedge randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics 3 clinics per step 5 six-month steps Implementation strategies will include assessing for readiness audit and feedback building a community coalition engaging consumers modifying referral tracking and training and educating clinical stakeholders The research team will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership OMOP Common Data Model additional patient-reported data and study tracking logs to measure reach effectiveness adoption implementation and will use qualitative measures and site observations to document contextual factors including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or colorectal cancer screening completion
Detailed Description:
Colorectal cancer CRC screening is recommended by the United States Preventative Services Task Force for adults age 45-75 Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities While patient navigation is an evidence-based approach to improve screening there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices particularly using a health-equity focused stakeholder-centered approach Guided by the Practical Robust Implementation and Sustainability Model PRISM and core health and racial equity principles the investigative team aims to increase reach of patient navigation and show effectiveness through improvement in the percentage of Black and Hispanic patients completing CRC screening Investigators will also utilize longitudinal tracking of implementation strategies to better track implementation or intervention adaptations navigation delivery in order to inform future scale up The research team will conduct a stepped-wedged randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics 3 clinics per step 5 six-month steps Implementation strategies will include assessing for readiness audit and feedback building a community coalition engaging consumers modifying referral tracking and training and educating clinical stakeholders Researchers will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership OMOP Common Data Model additional patient-reported data and study tracking logs to measure reach effectiveness adoption implementation and will use qualitative measures and site observations to document contextual factors including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or CRC screening completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None