Trial Outcomes & Findings for Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC (NCT NCT04890054)

Last Updated: 2025-08-19

Results Overview

Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number \[%\] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.

Recruitment status

COMPLETED

Study phase

Target enrollment

5696 participants

Primary outcome timeframe

Primary outcome at 6 months following CCO eligible patient list pull date,

Results posted on

2025-08-19

Participant Flow

Recruited clinics affiliated with three Medicaid health plans that serve rural counties in Oregon. Clinics had at least 30 age-eligible Medicaid or dually enrolled in Medicaid and Medicare; had CRC screening rates of 60% or lower; and operated in a geographic region designated as rural or frontier. Eligible individuals are ages 50-74 and eligible for CRC screening. Recruitment of clinics happened between May 2020-April 2021.

Stratified allocation assignments by clinic unit affiliation (hospital-affiliated, health care network-affiliated, clinic, etc.)

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	SMARTER CRC Intervention Year 1 In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators	SMARTER CRC Usual Care Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Overall Study STARTED	2655 14	3041 14
Overall Study Patients	2613 14	3001 14
Overall Study Staff	42 14	40 14
Overall Study COMPLETED	2453 14	2822 14
Overall Study NOT COMPLETED	202 0	219 0

Reasons for withdrawal

Reasons for withdrawal
Measure	SMARTER CRC Intervention Year 1 In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators	SMARTER CRC Usual Care Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Overall Study Lost to Follow-up	202	219

Baseline Characteristics

Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.	Total n=5614 Participants Total of all reporting groups
Age, Continuous	58.1 Years STANDARD_DEVIATION 5.4 • n=93 Participants	58.3 Years STANDARD_DEVIATION 5.6 • n=4 Participants	58.2 Years STANDARD_DEVIATION 5.5 • n=27 Participants
Sex: Female, Male Female	1334 Participants n=93 Participants	1614 Participants n=4 Participants	2948 Participants n=27 Participants
Sex: Female, Male Male	1279 Participants n=93 Participants	1387 Participants n=4 Participants	2666 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	135 Participants n=93 Participants	190 Participants n=4 Participants	325 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2357 Participants n=93 Participants	2583 Participants n=4 Participants	4940 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	121 Participants n=93 Participants	228 Participants n=4 Participants	349 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	97 Participants n=93 Participants	50 Participants n=4 Participants	147 Participants n=27 Participants
Race (NIH/OMB) Asian	30 Participants n=93 Participants	21 Participants n=4 Participants	51 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Black or African American	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Race (NIH/OMB) White	1745 Participants n=93 Participants	2029 Participants n=4 Participants	3774 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	721 Participants n=93 Participants	879 Participants n=4 Participants	1600 Participants n=27 Participants
Region of Enrollment United States	2613 participants n=93 Participants	3001 participants n=4 Participants	5614 participants n=27 Participants
Insurance Status Medicaid	2157 Participants n=93 Participants	2398 Participants n=4 Participants	4555 Participants n=27 Participants
Insurance Status Dual Eligible	456 Participants n=93 Participants	603 Participants n=4 Participants	1059 Participants n=27 Participants
Rurality (RUCA Codes) Metropolitan	70 Participants n=93 Participants	730 Participants n=4 Participants	800 Participants n=27 Participants
Rurality (RUCA Codes) Micropolitan	1722 Participants n=93 Participants	1680 Participants n=4 Participants	3402 Participants n=27 Participants
Rurality (RUCA Codes) Small Town	431 Participants n=93 Participants	156 Participants n=4 Participants	587 Participants n=27 Participants
Rurality (RUCA Codes) Rural	384 Participants n=93 Participants	432 Participants n=4 Participants	816 Participants n=27 Participants
Rurality (RUCA Codes) Unknown or Missing	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants

PRIMARY outcome

Timeframe: Primary outcome at 6 months following CCO eligible patient list pull date,

Population: Intention to treat, multi-level within clinics. One clinic closed immediately after randomization and before patients could be determined eligible before the intervention began.

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients)	11.8 Percentage of participants Interval 10.0 to 13.5	4.5 Percentage of participants Interval 3.6 to 5.4

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intent to treat, multi-level within clinics. One clinic closed after randomization and before the intervention began.

Completed CRC screening at 12 months. Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy).

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Completion of CRC Screening	16.8 Percentage of participants Interval 15.3 to 18.2	9 Percentage of participants Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: 6 months

Population: Patients NOT excluded during the clinic scrub, expected for intervention components.

In the intervention clinics only, the list of patients eligible for screening was scrubbed by clinics. This percent is the N completed CRC screening out of the N included in intervention outreach after clinics scrubbed the list of eligible patients.

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Rate of CRC Screening Among the Intervention-eligible Population	181 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intent to treat eligible patients at clinics

Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level.

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Time to Screening From Study-eligible Patient List Pull	118.5 Days Standard Deviation 293.9	103.2 Days Standard Deviation 383.2

SECONDARY outcome

Timeframe: 6 months

Population: Intent to treat

Number of participants with abnormal FIT Results

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Abnormal FIT Results	19 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: A subset of the total population of clinic staff, who were invited to the patient navigation training

Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=42 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Patient Navigation Trainings (Intervention Group)	22 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Patients in intervention clinics eligible for navigation to colonoscopy due to FIT test result or medical factors

Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=35 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Patient Navigation Completed (Intervention Group)	22 Participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intention to treat, patients in clinics

The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Follow-up Colonoscopy Completion	49.1 Percent of participants	19.7 Percent of participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intention to treat, patients in clinics

Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Time to Colonoscopy From Abnormal FIT Result	96.3 Days Interval 72.6 to 119.9	114.6 Days Interval 50.0 to 179.2

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intention to treat, patients in clinics

Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=2613 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care n=3001 Participants Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Adenomas or Cancers Detected Adenomas	7 participants	14 participants
Adenomas or Cancers Detected Cancers	1 participants	4 participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: Clinic or CCO staff, including patient navigators, who were involved in implementation of the intervention

Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers.

Outcome measures

Outcome measures
Measure	SMARTER CRC Intervention Year 1 n=82 Participants In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators.	SMARTER CRC Usual Care Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations.
Key Implementation Barriers COVID disruptions	4 Participants	—
Key Implementation Barriers Staffing Disruptions	19 Participants	—
Key Implementation Barriers Mailing Delays	5 Participants	—
Key Implementation Barriers Did Not Mention	54 Participants	—

Adverse Events

SMARTER CRC Intervention Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Staff Members

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Staff Members

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Durr, M.P.H.

Oregon Rural Practice Research Network

Phone: 503-418-3592

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place