Patient Navigation for Colorectal Cancer Screening

Official title

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Overview

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.

Interventions

• Behavioral 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

Primary outcome measures

• Colorectal cancer screening completion [Time frame: 12 months]

Secondary outcome measures (6)

• Reach [Time frame: 6 months]
• Adoption [Time frame: 6 months]
• Acceptability measured by the Acceptability of Intervention Measure (AIM) [Time frame: 12 months]
• Appropriateness measured by the Intervention Appropriateness Measure (IAM) [Time frame: 12 months]
• Feasibility measured by the Feasibility of Implementation Measure (FIM) [Time frame: 12 months]
• Sustainability measured by the clinical sustainability assessment tool [Time frame: 12 months]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Screening

Study locations

United States · 15 centers

• Internal Medicine Wisconsin Avenue — Washington D.C.
• Family Medicine Spring Valley — Washington D.C.
• Primary Care Lafayette — Washington D.C.
• Family Medicine Fort Lincoln — Washington D.C.
• Honeygo — Baltimore
• MedStar Adult Medicine at Union Memorial — Baltimore
• Harbor Hospital Primary Care Federal Hill — Baltimore
• Franklin Square — Baltimore
• … and 7 more centers

Publications

• Rivera Rivera JN, AuBuchon KE, Schubel LC, Starling C, Tran J, Locke M, Grady M, Mete M, Blumenthal HJ, Galarraga JE, Arem H. Supporting ColoREctal Equitable Navigation (SCREEN): a protocol for a stepped-wedge cluster randomized trial for patient navigation in primary care. Implement Sci Commun. 2024 Jun 3;5(1):60. doi: 10.1186/s43058-024-00598-5. PMID 38831365

Identifiers

NCT: NCT06401174 · 6963

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗