Rural Colon Cancer Screening Toolkit Intervention

The Washington University

Status: Enrolling

Conditions: Colon Cancer Screening

Treatments: Other: Colorectal Cancer Toolkit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04651504

5R01CA233848-02 (U.S. NIH Grant/Contract)

202010206

Details and patient eligibility

About

Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.

Enrollment: 83,663 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Primary Care Clinic Sites

• Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare

Exclusion Criteria for Primary Care Clinic Sites

• Not a part of the PHO

Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites

• Employment at the relevant clinic at the time of the study

Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites

• Not employed at the relevant clinic at the time of the study

Inclusion Criteria for Patients

• Age 45-75 during the study period
• Must be patient of the selected primary care clinic sites

Exclusion Criteria for Patients

• Younger than 45 years of age or older than 75 years of age during the study period
• Not a patient of the selected primary care clinic sites

Inclusion Criteria for Community Members

• Age 45-75 at the time of the health fair or screening event
• Able to undergo stool testing as determined by SIH staff at the health fair or screening event

Exclusion Criteria for Community Members

• Younger than 45 years of age or older than 75 years of age
• Unable to undergo stool testing

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

83,663 participants in 1 patient group

Primary Care Clinics

Experimental group

Description:

* Southern Illinois Healthcare System will contact the site management and ask for participation in the study * Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.

Treatment:

Other: Colorectal Cancer Toolkit