Trial Title:
Patient Navigation for Colorectal Cancer Screening
NCT ID:
NCT06401174
Condition:
Colorectal Cancer Screening
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
disparities
Patient navigation
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Step wedge trial with 5 six-month steps, three clinics at a time, for a total of 15
clinics.
Primary purpose:
Screening
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Delivery of patient navigation
Description:
Clinics will receive educational materials and access a referral order for patient
navigation. Iterative strategies will be used to increase CRC screening
Arm group label:
Patient navigation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 45-75
- Due for colorectal cancer screening
- Identify as Black or Hispanic/Latino
- Attend primary care visit at one of the 15 selected clinics within the step time
-period
Exclusion Criteria:
-
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Internal Medicine Wisconsin Avenue
Address:
City:
Washington
Zip:
20007
Country:
United States
Facility:
Name:
Family Medicine Spring Valley
Address:
City:
Washington
Zip:
20016
Country:
United States
Facility:
Name:
Primary Care Lafayette
Address:
City:
Washington
Zip:
20036
Country:
United States
Facility:
Name:
Family Medicine Fort Lincoln
Address:
City:
Washington
Zip:
20722
Country:
United States
Facility:
Name:
Honeygo
Address:
City:
Baltimore
Zip:
21128
Country:
United States
Facility:
Name:
MedStar Adult Medicine at Union Memorial
Address:
City:
Baltimore
Zip:
21218
Country:
United States
Facility:
Name:
Harbor Hospital Primary Care Federal Hill
Address:
City:
Baltimore
Zip:
21230
Country:
United States
Facility:
Name:
Franklin Square
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Facility:
Name:
Primary Care at Franklin Square
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Facility:
Name:
Charlotte Hall
Address:
City:
Charlotte Hall
Zip:
20622
Country:
United States
Facility:
Name:
Internal Medicine Clinton
Address:
City:
Clinton
Zip:
20735
Country:
United States
Facility:
Name:
Family Medicine
Address:
City:
Gaithersburg
Zip:
20878
Country:
United States
Facility:
Name:
Internal Medicine Hyattsville
Address:
City:
Hyattsville
Zip:
20782
Country:
United States
Facility:
Name:
Family Medicine
Address:
City:
Olney
Zip:
20832
Country:
United States
Facility:
Name:
Olney Prof Park
Address:
City:
Olney
Zip:
20832
Country:
United States
Start date:
June 1, 2024
Completion date:
July 30, 2028
Lead sponsor:
Agency:
Medstar Health Research Institute
Agency class:
Other
Collaborator:
Agency:
National Committee for Quality Assurance
Agency class:
Other
Source:
Medstar Health Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06401174
