Colon Cancer Screening
Conditions
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.
Interventions
OTHERColorectal Cancer Toolkit
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.
Sponsors
Washington University School of Medicine
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test | Within 60 days after receipt of positive FIT/FOBT | * 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. |
| Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT) | Within 60 days of referral to Gastroenterology | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Colonoscopy | Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 days | Time between FIT date and colonoscopy. |
| 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 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAimee James, Ph.D., MPH
Washington University School of Medicine
Participant flow
Pre-assignment details
A total of 52 primary care clinics participated in the study. 39 primary care clinics only provided control data. 13 primary care clinics provided control data and participated in the intervention (4 clinics in Step Wedge 1 and 9 clinics in Step Wedge 2). Participants were counted only once during the study (when data was first collected) and did not overlap between period years.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.75 years STANDARD_DEVIATION 10.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 479 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97456 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19466 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 139 Participants |
| Race (NIH/OMB) Asian | 298 Participants |
| Race (NIH/OMB) Black or African American | 1939 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 56 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25171 Participants |
| Race (NIH/OMB) White | 149931 Participants |
| Region of Enrollment United States | 185903 participants |
| Sex/Gender, Customized Female | 8004 Participants |
| Sex/Gender, Customized Male | 5845 Participants |
| Sex/Gender, Customized Unknown | 710 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed