Trial Outcomes & Findings for Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up (NCT NCT04514341)

Last Updated: 2026-01-14

Results Overview

The number of patients aged 50-75 years who were up-to-date with colorectal cancer screening during each implementation phase.

Recruitment status

COMPLETED

Target enrollment

4 participants

Primary outcome timeframe

From date of randomization until the last subject completed the study. This could have been up to 36 months.

Results posted on

2026-01-14

Participant Flow

The study recruited four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. Together, these four FQHCs operate 65 primary care clinics and served 131,233 individual patients in 2020. One FQHC from each state was randomly assigned to Group 1, while the remaining two were assigned to Group 2. Both groups received the intervention; the only distinction was that implementation in Group 2 was delayed by three months compared to Group 1.

Unit of analysis: FQHCs

Participant milestones

Participant milestones
Measure	Group 1 The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The enrollment number reflects the total number of individual patients seen at each facility (FQHC) during each study phase. Because the study was conducted at the facility level, no individual consent or enrollment occurred. Additionally, the provider and staff education component was conducted at the facility (FQHC) level and did not target individual providers. Therefore, provider characteristics were not assessed at baseline and were not included in the Participant Flow or adverse event reporting. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components, baseline data collection only * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The enrollment number reflects the total number of individual patients seen at each facility (FQHC) during each study phase. Because the study was conducted at the facility level, no individual consent or enrollment occurred. Additionally, the provider and staff education component was conducted at the facility (FQHC) level and did not target individual providers. Therefore, provider characteristics were not assessed at baseline and were not included in the Participant Flow or adverse event reporting. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components, baseline data collection only * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
Baseline (Months 0-12) STARTED	18099 2	20834 2
Baseline (Months 0-12) Group 1 and Group 2 collect baseline data only, no intervention	18099 2	20834 2
Baseline (Months 0-12) COMPLETED	18099 2	20834 2
Baseline (Months 0-12) NOT COMPLETED	0 0	0 0
Step 1 (Months 13-18) STARTED	19318 2	18878 2
Step 1 (Months 13-18) Both Group 1 and Group 2 receive Component 1 (Provider and Staff Education)	19318 2	18878 2
Step 1 (Months 13-18) COMPLETED	19318 2	18878 2
Step 1 (Months 13-18) NOT COMPLETED	0 0	0 0
Step 2 (Months 19-21) STARTED	21102 2	15725 2
Step 2 (Months 19-21) Group 1 receives Component 2 (SMS Reminders)	21102 2	0 0
Step 2 (Months 19-21) COMPLETED	21102 2	0 0
Step 2 (Months 19-21) NOT COMPLETED	0 0	15725 2
Step 3 (Months 22-30) STARTED	21102 2	15725 2
Step 3 (Months 22-30) Both Groups Receive Component 1 and Componet 2	21102 2	15725 2
Step 3 (Months 22-30) COMPLETED	21102 2	15725 2
Step 3 (Months 22-30) NOT COMPLETED	0 0	0 0
Step 4 (Months 31-33) STARTED	21602 2	15037 2
Step 4 (Months 31-33) Group 1 receives all three components (provider and staff education+SMS Reminders+ Remote PN)	21602 2	0 0
Step 4 (Months 31-33) COMPLETED	21602 2	0 0
Step 4 (Months 31-33) NOT COMPLETED	0 0	15037 2
Step 5 (Months 34-45) STARTED	21602 2	15037 2
Step 5 (Months 34-45) Both Groups Receive All Three Components	21602 2	15037 2
Step 5 (Months 34-45) COMPLETED	21602 2	15037 2
Step 5 (Months 34-45) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The enrollment number reflects the total number of individual patients seen at each facility (FQHC) during each study phase. Because the study was conducted at the facility level, no individual consent or enrollment occurred. Additionally, the provider and staff education component was conducted at the facility (FQHC) level and did not target individual providers. Therefore, provider characteristics were not assessed at baseline and were not included in the Participant Flow or adverse event reporting. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components, baseline data collection only * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The enrollment number reflects the total number of individual patients seen at each facility (FQHC) during each study phase. Because the study was conducted at the facility level, no individual consent or enrollment occurred. Additionally, the provider and staff education component was conducted at the facility (FQHC) level and did not target individual providers. Therefore, provider characteristics were not assessed at baseline and were not included in the Participant Flow or adverse event reporting. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components, baseline data collection only * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
Step 2 (Months 19-21) In a 3-month delay period	0	15725
Step 4 (Months 31-33) In a 3-month delay period	0	15037

Baseline Characteristics

Patients who were between the ages of 50 and 75 at each FQHC, with FQHC 1 in both groups located in Illinois and FQHC 2 in each group located in Indiana.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From date of randomization until the last subject completed the study. This could have been up to 36 months.

Population: The overall number represents all participants across all study phases. The number analyzed reflects only participants contributing data at the reported phase.

The number of patients aged 50-75 years who were up-to-date with colorectal cancer screening during each implementation phase.

Outcome measures

Outcome measures
Measure	Group 1 n=62022 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 n=49640 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
CRC Screening Rate Phase 3: Provider and Staff Education + Patient Reminders + Remote Patient Navigation	10720 Participants	3303 Participants
CRC Screening Rate Phase 1: Provider and Staff Education	8611 Participants	3989 Participants
CRC Screening Rate Phase 2: Provider Education + Patient Reminder	9438 Participants	3186 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date subject completed the study. This could have been up to 36 months.

Population: The overall number represents all participants who needed screening across all study Phases. The number analyzed reflects only participants contributing data at the reported phase.

The number of patients between the ages of 50 and 75 who needed CRC screening and received a screening order (excluding participants who received an order but have already been up to date with screening ) during each implementation phase.

Outcome measures

Outcome measures
Measure	Group 1 n=41263 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 n=43243 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
CRC Screening Ordering Rate Phase 2: Provider and Staff Education + Patient Reminders	6458 Participants	4757 Participants
CRC Screening Ordering Rate Phase 1: Provide and Staff Education	7012 Participants	5087 Participants
CRC Screening Ordering Rate Phase 3: Provide and Staff Education + Patient Reminders + Remote Patient Navigation	6478 Participants	4611 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date subject completed the study. This could have been up to 36 months.

Population: The overall number represents all participants who needed CRC screening and received an order across all study phases. The number analyzed reflects only participants contributing data at the reported milestone.

The number of patients between the ages of 50 and 75 who needed CRC screening, received an order for screening, and completed the screening during each implementation phase.

Outcome measures

Outcome measures
Measure	Group 1 n=19948 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 n=14455 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
CRC Screening Completion Rate Phase 1: Provider and Staff Educatioin	3106 Participants	1917 Participants
CRC Screening Completion Rate Phase 2: Provider and Staff Education + Patient Reminders	3031 Participants	1749 Participants
CRC Screening Completion Rate Phase 3: Provider and Staff Education + Patient Reminders + Remote Patient Navigation	3278 Participants	1691 Participants

SECONDARY outcome

Timeframe: From the date of the first education session until the completion of the last education sessions. This could have been up to 24 months.

Population: The overall number represents the total number of providers invited to the education sessions during Phase 1 and Phase 2. The number analyzed reflects the number of providers invited to the education sessions during the reported phase.

The number of providers who attended the annual education sessions during Phase 1 and Phase 2. To accommodate the COVID-19 restrictions, all sessions were delivered via Zoom, with multiple sessions scheduled within each FQHC based on clinic availability. Both groups received the education component simultaneously, with no delay in implementation.

Outcome measures

Outcome measures
Measure	Group 1 n=527 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 n=340 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
Provider Education Participation Phase 1: Provider and Staff Education	129 Participants	44 Participants
Provider Education Participation Phase 2: Provider and Staff Education + Patient Reminders	126 Participants	89 Participants

SECONDARY outcome

Timeframe: From the initiation of the SMS reminder system until the last participant enrolled. This could have been up to 30 months.

Population: The overall number represents the total number of participants who received a FIT or colonoscope order during the implementation of Phase 1 and Phase 2. The number analyzed reflects only the number of participants contributing data to the reported milestone.

The number of participants who received a FIT or colonoscopy order (excluding Cologuard, which provides its own reminder services) and subsequently enrolled in the short message service (SMS) reminder system during Phase 2 and Phase 3. The SMS platform was used to engage participants and remind them to complete their screenings; participants could opt out at any time by replying "STOP".

Outcome measures

Outcome measures
Measure	Group 1 n=13013 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3	Group 2 n=10824 Participants The study was conducted in four federally qualified health centers (FQHCs): two in Illinois and two in Indiana. One FQHC from Illinois and one from Indiana were randomly assigned to Group 1, and the remaining two formed Group 2. Both groups received all intervention components except that Group 2 began the intervention three months later than Group 1. The intervention consists of three components: 1. Provider and staff education, 2. Patient reminders using short message services (SMS), and 3. Remote patient navigation (PN). Implementation was phased as follows: * Phase 0: No intervention components * Phase 1: Component 1 only * Phase 2: Components 1 + 2 * Phase 3: Components 1 + 2 +3
Patient Reminder Enrollment Phase 2: Provider and Staff Education + Patient Reminders	4756 Participants	4693 Participants
Patient Reminder Enrollment Phase 3: Provider and Staff Education + Patient Reminders + Remote Patient Navigation	5198 Participants	3943 Participants

SECONDARY outcome

Timeframe: From the navigation service initiated at the partner FQHC until the completion of the study, assessed up to 16 months.

Population: The overall number represents the number of participants whom the navigators successfully contacted and spoke to during Phase 3.

The number of participants who received remote navigation services (phone-based navigation) during Phase 3 and subsequently completed their screenings.