Colorectal Carcinoma
Conditions
Brief summary
This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.
Detailed description
PRIMARY OBJECTIVE: I. To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC). OUTLINE: Clinic sites are randomized to 1 of 2 groups. GROUP I CLINICS: Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial. GROUP II CLINICS: Physicians and clinic staff provide and patients receive CRC screening usual care throughout the trial.
Interventions
OTHERBest Practice
Receive CRC screening usual care
OTHERConsultation
Receive consultation with clinic staff
OTHEREducational Intervention
Receive education and training on CRC screening
OTHERElectronic Health Record Review
Ancillary studies
Receive FIT kit with culturally tailored instructions
BEHAVIORALFeedback
Receive feedback on CRC screening
BEHAVIORALHealth Education
Receive CRC screening recommendations
Utilize clinical decision support tool
Receive text message reminders
Sponsors
Tobacco Related Disease Research Program
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* PATIENTS: 50-75 years of age * PATIENTS: \>= 1 clinic visit/past 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal cancer (CRC) screening rate | Up to 3 years | Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients. |
| Rate of failure to provide a FIT kit to an eligible patient making a clinic visit | Up to 3 years | Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients. |
| Return rate of completed FIT kits | Up to 3 years | The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients. |
Countries
United States
Outcome results
None listed