Rural Colon Cancer Screening Toolkit Intervention

NCT04651504 | Completed Results

• 2 other identifiers: 2020102065R01CA233848-02
• Study Type: interventional
• Target: 185,903
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer Screening

Outcome Measures

Primary Outcomes (2)

• Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test

  * Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test. * Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.

  Within 60 days after receipt of positive FIT/FOBT

• Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)

  Within 60 days of referral to Gastroenterology

Secondary Outcomes (3)

• Time to Colonoscopy

  Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 days

• Proportion of Participants Who Initiate a Colonoscopy Within 14 Days of Positive Fecal Immunochemical Test

  Within 14 days of positive fecal immunochemical test

• Proportion of Patients Who Complete a Complete Diagnostic Evaluation Within 60 Days of Positive Fecal Immunochemical Test

  Within 60 days after receipt of positive FIT/FOBT

Study Arms (1)

Primary Care Clinics

EXPERIMENTAL

* 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. * At least 6 months of control data collection before clinics begin receiving the intervention.

Other: Colorectal Cancer Toolkit

Interventions

Colorectal Cancer Toolkit OTHER

The intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process.

Primary Care Clinics

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not a part of the PHO
• Employment at the relevant clinic at the time of the study
• Not employed at the relevant clinic at the time of the study
• Age 45-75 during the study period
• Must be patient of the selected primary care clinic sites
• 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
• 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
• Younger than 45 years of age or older than 75 years of age
• Unable to undergo stool testing

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Limitations and Caveats

Registry data come from EHR platforms, and may be incomplete, and data fields may vary across platforms. For this reason, registry data was not complete for all anticipated fields. Covid-19 caused delays in colonoscopy due to shutdowns and staff shortages. System-wide strategies were needed to address delays, hence we no longer expected an intervention effect on time to screening. Percentage of patients screened by any method is likely to be more reflective of intervention effects.

Results Point of Contact

• Title: Dr. Aimee James
• Organization: Washington University School of Medicine

aimeejames@wustl.edu

314-454-8300

Study Officials

• Aimee James, Ph.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a stepped wedge trial where clusters of sites sequentially enter the intervention. Independent samples of patients are enrolled within a cluster at each set interval of time thus, it is analyzed as a repeated cross-sectional study.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: December 2, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 5, 2026
• Results First Posted: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)