ColoRectal Cancer Screening for Southern California Community Health Centers

University of California San Diego

Status and phase

Completed

Phase 3

Conditions

Colorectal Cancer

Treatments

Other: Mailed FIT Outreach

Other: Standardized navigation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04941300

IRB # 190990

5UH3CA233314-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.

The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.

The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.

Enrollment

55,999 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Mailed FIT Inclusion Criteria:

Patient had an office visit within the last 12 months at one or more of your health centers. (Use Uniform Data System [UDS] criteria for an office visit.)
Not up to date with colorectal cancer screening according to the standard UDS query
Male or Female
50 - 75 years old
Current VALID address in San Diego or Riverside Counties (addresses with a PO box or General Delivery are acceptable)
Valid Phone Number
Insured patients only (e.g., Medicare, Medi-Cal, or private insurance)

Exclusion Criteria:

Absence of a phone number listed in the Electronic Health Record/Electronic Medical Record (EMR)
Absence of a valid mailing address (e.g. blank field)
Uninsured
Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
Duplicate patients within a health center organization. (If a patient was seen at multiple locations within the past year, only include the patient in the sample for the site where the patient was seen last)

Care Coordination for Abnormal FIT results, add the following to the inclusion criteria:

Completion of a FIT for Colorectal Cancer Screening during the designated time period
Abnormal FIT result received and documented in EMR during the designated time period