Clinical trial NCT06401174: Patient Navigation for Colorectal Cancer Screening
Official title: Bridging the Gap: Delivering Equitable Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: disparities
Patient navigation
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: National Committee for Quality Assurance
First posted: 2024-05-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

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.

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:

-

Primary outcomes:
measure: Colorectal cancer screening completion
timeFrame: 12 months
Secondary outcomes:
measure: Reach
timeFrame: 6 months
measure: Adoption
timeFrame: 6 months
measure: Acceptability measured by the Acceptability of Intervention Measure (AIM)
timeFrame: 12 months
measure: Appropriateness measured by the Intervention Appropriateness Measure (IAM)
timeFrame: 12 months
measure: Feasibility measured by the Feasibility of Implementation Measure (FIM)
timeFrame: 12 months
measure: Sustainability measured by the clinical sustainability assessment tool
timeFrame: 12 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Internal Medicine Wisconsin Avenue
state: District of Columbia
city: Washington
country: United States
facility: Family Medicine Spring Valley
state: District of Columbia
city: Washington
country: United States
facility: Primary Care Lafayette
state: District of Columbia
city: Washington
country: United States
facility: Family Medicine Fort Lincoln
state: District of Columbia
city: Baltimore
country: United States
facility: Honeygo
state: Maryland
city: Baltimore
country: United States
facility: MedStar Adult Medicine at Union Memorial
state: Maryland
city: Baltimore
country: United States
facility: Harbor Hospital Primary Care Federal Hill
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square
state: Maryland
city: Baltimore
country: United States
facility: Primary Care at Franklin Square
state: Maryland
city: Charlotte Hall
country: United States
facility: Charlotte Hall
state: Maryland
city: Clinton
country: United States
facility: Internal Medicine Clinton
state: Maryland
city: Gaithersburg
country: United States
facility: Family Medicine
state: Maryland
city: Hyattsville
country: United States
facility: Internal Medicine Hyattsville
state: Maryland
city: Olney
country: United States
facility: Family Medicine
state: Maryland
city: Olney
country: United States
facility: Olney Prof Park
state: Maryland
Study officials:
References: