Patient Navigation for Colorectal Cancer Screening

Colorectal Cancer Screening Clinical Trial

— SCREEN  

Official title:

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401174
• Other study ID #: 6963
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: July 30, 2028

Study information

• Verified date: May 2024
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1800
• Est. completion date: July 30, 2028
• Est. primary completion date: January 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Franklin Square	Baltimore	Maryland
United States	Harbor Hospital Primary Care Federal Hill	Baltimore	Maryland
United States	Honeygo	Baltimore	Maryland
United States	MedStar Adult Medicine at Union Memorial	Baltimore	Maryland
United States	Primary Care at Franklin Square	Baltimore	Maryland
United States	Charlotte Hall	Charlotte Hall	Maryland
United States	Internal Medicine Clinton	Clinton	Maryland
United States	Family Medicine	Gaithersburg	Maryland
United States	Internal Medicine Hyattsville	Hyattsville	Maryland
United States	Family Medicine	Olney	Maryland
United States	Olney Prof Park	Olney	Maryland
United States	Family Medicine Fort Lincoln	Washington	District of Columbia
United States	Family Medicine Spring Valley	Washington	District of Columbia
United States	Internal Medicine Wisconsin Avenue	Washington	District of Columbia
United States	Primary Care Lafayette	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	National Committee for Quality Assurance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer screening completion	Completion of any USPSTF approved screening test	12 months
Secondary	Reach	Percent of patients referred out of those eligible	6 months
Secondary	Adoption	Percent of providers referring to patient navigation	6 months
Secondary	Acceptability measured by the Acceptability of Intervention Measure (AIM)	Stakeholder assessments of acceptability of navigation and implementation strategies measured on a four-item scale	12 months
Secondary	Appropriateness measured by the Intervention Appropriateness Measure (IAM)	Stakeholder assessments of appropriateness of navigation and implementation strategies measured on a four-item scale	12 months
Secondary	Feasibility measured by the Feasibility of Implementation Measure (FIM)	Stakeholder assessments of feasibility of navigation and implementation strategies measured on 4 item scale	12 months
Secondary	Sustainability measured by the clinical sustainability assessment tool	Understanding clinical sustainability of interventions	12 months