Clinical trial NCT04941300: ColoRectal Cancer Screening for Southern California Community Health Centers
Official title: CRC-HUB-SPOKE: a ColoRectal Cancer Screening Hub for Southern California Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: screening
underserved populations
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-28
Enrollment: 55999
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Screening up-to-date (primary)
timeFrame: Three years
measure: Colonoscopy after abnormal FIT (primary)
timeFrame: Six months
Secondary outcomes:
measure: FIT Completion
timeFrame: Twelve months
measure: Time to colonoscopy after abnormal FIT
timeFrame: From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years
measure: Follow-up process
timeFrame: From date of abnormal FIT results until the date of follow-up process is completed if a CRC is found, assessed up to 3 years
Other outcomes:
measure: Repeat screening (exploratory outcome)
timeFrame: 12-14 months
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego, Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Maria E Martinez
role: PRINCIPAL_INVESTIGATOR
References: