Colon Cancer, Colorectal Cancer, Colorectal Cancer (CRC) Screening, CRC Screening, Rectal Cancer
Conditions
Keywords
Colorectal cancer, Screening, Primary care, Teaching clinics
Brief summary
This is a mixed-methods implementation pilot combining an educational intervention with a mailed stool-based testing outreach feasibility study within a resident primary care clinic. Participants will be assigned by clinic team to education, mailed FIT, mailed Cologuard, or usual care comparison groups.
Interventions
BEHAVIORALColorectal Cancer Education Materials
Education materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope. The education materials are at a 6th grade reading level. Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes.
DIAGNOSTIC_TESTCologuard test kit
The Cologuard test will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
DIAGNOSTIC_TESTFecal immunochemical test kit
The Fecal immunochemical test (FIT) will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
BEHAVIORALUsual Care
Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
All patients are assigned to a resident primary care provider. Each resident is assigned to a team-based structure within the resident clinic, and there are 12 resident teams. Each team is composed of 12 residents, and each resident has a patient panel of \ 100 patients. Participants will be recruited via resident patient panels and randomized 1:1:1 by resident clinic teams. The Education Arm will be drawn from patients who agreed to be recontacted from a prior study and will not be randomized.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Phase 1 Education Arm Inclusion Criteria: * Previously enrolled in prior study IRB #202202059 who agreed to participate in future research Phase 1 Education Arm
Exclusion criteria
* Not enrolled in prior study IRB #202202059 Phase 2 (All Other Arms) Inclusion Criteria: * Primary Care Medicine Clinic patient (PRMC) * Eligible for CRC screening * Between age 45-75 years old * Have eligible health insurance Phase 2 (All Other Arms)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CRC knowledge (Education Arm only) | At enrollment and 3 months after educational intervention (total estimated time is 3 months) | Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test. The ACCL consists of 10-items with True/False/Unsure. The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy. |
| Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only) | At 3 months after receiving kit (total estimated time 3 months) | — |
| Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only) | At completion of testing or at 3 months after receiving test kit (total estimated time 3 months) | Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3). The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent. Generally, the higher the score indicates greater customer satisfaction. |
| CRC screening completion rate (All arms) | From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months) | CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion. |
Countries
United States
Contacts
CONTACTCassandra Fritz, MD, MPHS
CONTACTDarren Nix
PRINCIPAL_INVESTIGATORCassandra Fritz, MD, MPHS
Washington University School of Medicine
Outcome results
None listed