Patient Navigation for Colorectal Cancer Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2028-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Step wedge trial with 5 six-month steps, three clinics at a time, for a total of 15 clinics.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patient navigation

Patient navigation will be rolled out at the clinic level (15 clinics). Referral orders will become available to participating clinics, with education and audit and feedback for providers. The study team will tailor patient navigation supports by clinic site for specifics on how the intervention is delivered.

Group Type EXPERIMENTAL

Delivery of patient navigation

Intervention Type BEHAVIORAL

Clinics will receive educational materials and access a referral order for patient navigation. Iterative strategies will be used to increase CRC screening

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Delivery of patient navigation

Clinics will receive educational materials and access a referral order for patient navigation. Iterative strategies will be used to increase CRC screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Internal Medicine Wisconsin Avenue

Washington D.C., District of Columbia, United States

Site Status

Family Medicine Spring Valley

Washington D.C., District of Columbia, United States

Site Status

Primary Care Lafayette

Washington D.C., District of Columbia, United States

Site Status