Trial Outcomes & Findings for Rural Colon Cancer Screening Toolkit Intervention (NCT NCT04651504)
NCT ID: NCT04651504
Last Updated: 2026-08-05
Results Overview
* Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test. * Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185903 participants
Primary outcome timeframe
Within 60 days after receipt of positive FIT/FOBT
Results posted on
2026-08-05
Participant Flow
A total of 52 primary care clinics participated in the study. 39 primary care clinics only provided control data. 13 primary care clinics provided control data and participated in the intervention (4 clinics in Step Wedge 1 and 9 clinics in Step Wedge 2). Participants were counted only once during the study (when data was first collected) and did not overlap between period years.
Unit of analysis: clinics
Participant milestones
| Measure |
Primary Care Clinics Step Wedge 1: Control Portion Year 1, Intervention Portion Years 2-4
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Step Wedge 2: Control Portion Years 1-3, Intervention Portion Year 4
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only Years 1-4
Only control data was collected at these Primary Care Clinics.
|
|---|---|---|---|
|
Step 1: Year 1 (2021)
STARTED
|
8518 4
|
25651 8
|
51779 32
|
|
Step 1: Year 1 (2021)
COMPLETED
|
8518 4
|
25651 8
|
51779 32
|
|
Step 1: Year 1 (2021)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 2: Year 2 (2022)
STARTED
|
1415 4
|
13893 8
|
30017 32
|
|
Step 2: Year 2 (2022)
COMPLETED
|
1415 4
|
13893 8
|
30017 32
|
|
Step 2: Year 2 (2022)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 3: Year 3 (2023)
STARTED
|
1296 4
|
6028 9
|
15560 33
|
|
Step 3: Year 3 (2023)
COMPLETED
|
1296 4
|
6028 9
|
15560 33
|
|
Step 3: Year 3 (2023)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 4: Year 4 (2024)
STARTED
|
3029 4
|
7811 9
|
20906 30
|
|
Step 4: Year 4 (2024)
COMPLETED
|
3029 4
|
7811 9
|
20906 30
|
|
Step 4: Year 4 (2024)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rural Colon Cancer Screening Toolkit Intervention
Baseline characteristics by cohort
| Measure |
Primary Care Clinics Step Wedge 1
n=14258 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Step Wedge 2
n=53383 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only
n=118262 Participants
Only control data was collected at these Primary Care Clinics.
|
Total
n=185903 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.19 years
STANDARD_DEVIATION 9.71 • n=20 Participants
|
63.75 years
STANDARD_DEVIATION 10.61 • n=20 Participants
|
62.93 years
STANDARD_DEVIATION 10.11 • n=40 Participants
|
62.96 years
STANDARD_DEVIATION 10.26 • n=6 Participants
|
|
Sex/Gender, Customized
Female
|
8004 Participants
n=20 Participants
|
29219 Participants
n=20 Participants
|
64603 Participants
n=40 Participants
|
101826 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Male
|
5845 Participants
n=20 Participants
|
23454 Participants
n=20 Participants
|
49017 Participants
n=40 Participants
|
78316 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Unknown
|
409 Participants
n=20 Participants
|
710 Participants
n=20 Participants
|
4642 Participants
n=40 Participants
|
5761 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
391 Participants
n=20 Participants
|
479 Participants
n=20 Participants
|
1340 Participants
n=40 Participants
|
2210 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12979 Participants
n=20 Participants
|
50641 Participants
n=20 Participants
|
97456 Participants
n=40 Participants
|
161076 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
888 Participants
n=20 Participants
|
2263 Participants
n=20 Participants
|
19466 Participants
n=40 Participants
|
22617 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
97 Participants
n=40 Participants
|
139 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
88 Participants
n=20 Participants
|
298 Participants
n=20 Participants
|
396 Participants
n=40 Participants
|
782 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
56 Participants
n=40 Participants
|
92 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1233 Participants
n=20 Participants
|
1939 Participants
n=20 Participants
|
6616 Participants
n=40 Participants
|
9788 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
11396 Participants
n=20 Participants
|
48045 Participants
n=20 Participants
|
90490 Participants
n=40 Participants
|
149931 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1521 Participants
n=20 Participants
|
3043 Participants
n=20 Participants
|
20607 Participants
n=40 Participants
|
25171 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
14258 participants
n=20 Participants
|
53383 participants
n=20 Participants
|
118262 participants
n=40 Participants
|
185903 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Within 60 days after receipt of positive FIT/FOBTPopulation: Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.
* Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test. * Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.
Outcome measures
| Measure |
Primary Care Clinics
n=76134 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
* Separate data for the Intervention and Control conditions/Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of some fields, including colonoscopy referrals (see Results Limitations and Caveats). Referral data were only able to be obtained from the hospital system sites that used EPIC, however, could not be differentiated by clinics/wedges, and therefore, cannot be differentiated per Control or Intervention condition.")
|
Primary Care Clinics Step Wedge 2
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only
Only control data was collected at these Primary Care Clinics.
|
|---|---|---|---|
|
Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test
|
329 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 60 days of referral to GastroenterologyPopulation: Over the study time period, individuals could receive \>1 FIT and thus can contribute more than 1 unit of data (instance of positive FIT followed by colonoscopy).
Outcome measures
| Measure |
Primary Care Clinics
n=147 instances of positive FITs
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
* Separate data for the Intervention and Control conditions/Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of some fields, including colonoscopy referrals (see Results Limitations and Caveats). Referral data were only able to be obtained from the hospital system sites that used EPIC, however, could not be differentiated by clinics/wedges, and therefore, cannot be differentiated per Control or Intervention condition.")
|
Primary Care Clinics Step Wedge 2
n=940 instances of positive FITs
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only
n=1270 instances of positive FITs
Only control data was collected at these Primary Care Clinics.
|
|---|---|---|---|
|
Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)
|
74 colonoscopy completions
|
374 colonoscopy completions
|
614 colonoscopy completions
|
SECONDARY outcome
Timeframe: Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 daysTime between FIT date and colonoscopy.
Outcome measures
| Measure |
Primary Care Clinics
n=147 instances of positive FITs
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
* Separate data for the Intervention and Control conditions/Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of some fields, including colonoscopy referrals (see Results Limitations and Caveats). Referral data were only able to be obtained from the hospital system sites that used EPIC, however, could not be differentiated by clinics/wedges, and therefore, cannot be differentiated per Control or Intervention condition.")
|
Primary Care Clinics Step Wedge 2
n=940 instances of positive FITs
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only
n=1270 instances of positive FITs
Only control data was collected at these Primary Care Clinics.
|
|---|---|---|---|
|
Time to Colonoscopy
|
162.10 days
Standard Deviation 258.10
|
160.72 days
Standard Deviation 253.67
|
154.44 days
Standard Deviation 231.18
|
SECONDARY outcome
Timeframe: Within 14 days of positive fecal immunochemical testPopulation: Only 1 individual can contribute to this outcome. In the event that an individual had \>1 FIT in the study time period, the first FIT was assessed. This data was available through SIH for the entire system (all clinics included) which is why the numbers are inconsistent when compared with referral data in Outcome Measure #1.
Outcome measures
| Measure |
Primary Care Clinics
n=139 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
* Separate data for the Intervention and Control conditions/Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of some fields, including colonoscopy referrals (see Results Limitations and Caveats). Referral data were only able to be obtained from the hospital system sites that used EPIC, however, could not be differentiated by clinics/wedges, and therefore, cannot be differentiated per Control or Intervention condition.")
|
Primary Care Clinics Step Wedge 2
n=907 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only
n=1235 Participants
Only control data was collected at these Primary Care Clinics.
|
|---|---|---|---|
|
Proportion of Participants Who Initiate a Colonoscopy Within 14 Days of Positive Fecal Immunochemical Test
|
45 Participants
|
150 Participants
|
281 Participants
|
SECONDARY outcome
Timeframe: Within 60 days after receipt of positive FIT/FOBTPopulation: Only 1 individual can contribute to this outcome. In the event that an individual had \>1 FIT in the study time period, the first FIT was assessed.
Outcome measures
| Measure |
Primary Care Clinics
n=139 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
* Separate data for the Intervention and Control conditions/Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of some fields, including colonoscopy referrals (see Results Limitations and Caveats). Referral data were only able to be obtained from the hospital system sites that used EPIC, however, could not be differentiated by clinics/wedges, and therefore, cannot be differentiated per Control or Intervention condition.")
|
Primary Care Clinics Step Wedge 2
n=907 Participants
* Southern Illinois Healthcare System will contact the site management and ask for participation in the study
* Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
* At least 6 months of control data collection before clinics begin receiving the intervention.
|
Primary Care Clinics Control Only
n=1235 Participants
Only control data was collected at these Primary Care Clinics.
|
|---|---|---|---|
|
Proportion of Patients Who Complete a Complete Diagnostic Evaluation Within 60 Days of Positive Fecal Immunochemical Test
|
69 Participants
|
358 Participants
|
597 Participants
|
Adverse Events
Primary Care Clinics Step Wedge 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Care Clinics Step Wedge 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Care Clinics Control Only
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
Dr. Aimee James
Washington University School of Medicine
Phone: 314-454-8300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place