Trial Outcomes & Findings for Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (NCT NCT04427527)
NCT ID: NCT04427527
Last Updated: 2026-09-04
Results Overview
This is the Y1 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
COMPLETED
NA
29772 participants
Y1 Follow-up
2026-09-04
Participant Flow
The project included 6 counties in Appalachian Kentucky and Appalachian Ohio (12 total). Counties were randomized into Early or Delayed Intervention Groups and paired. One primary care clinic in each county was recruited to participate in multi-level intervention (MLI) activities. Random sample of survey participants from each county were also recruited each year to complete surveys to analyze community level Colorectal Cancer (CRC) screening. No participants were followed from year to year.
Y0 baseline reflects a pre-randomization pilot phase that was not included in outcome analyses. Two counties initiated study implementation activities earlier to support start-up procedures. Data from these counties were included in baseline reporting but were excluded from outcome analyses. Randomized intervention comparisons began in Y1 Follow-up.
Unit of analysis: Counties
Participant milestones
| Measure |
Baseline Phase
Pilot baseline phase conducted prior to randomization and intervention implementation.
|
Early Intervention
Counties assigned to receive the intervention earlier in the study period.
|
Delayed Intervention
Counties assigned to receive the intervention later in the study period.
|
|---|---|---|---|
|
Y0 Baseline
STARTED
|
7692 2
|
0 0
|
0 0
|
|
Y0 Baseline
Survey Participants
|
1191 2
|
0 0
|
0 0
|
|
Y0 Baseline
Electronic Health Record (EHR) Data
|
6501 2
|
0 0
|
0 0
|
|
Y0 Baseline
COMPLETED
|
7692 2
|
0 0
|
0 0
|
|
Y0 Baseline
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Y1 Follow-up
STARTED
|
0 0
|
3627 6
|
6454 6
|
|
Y1 Follow-up
Survey Participants
|
0 0
|
592 6
|
607 6
|
|
Y1 Follow-up
Electronic Health Record (EHR) Data
|
0 0
|
3035 6
|
5847 6
|
|
Y1 Follow-up
COMPLETED
|
0 0
|
3627 6
|
6454 6
|
|
Y1 Follow-up
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Y2 Follow-up
STARTED
|
0 0
|
4729 6
|
7270 6
|
|
Y2 Follow-up
Survey Participants
|
0 0
|
599 6
|
590 6
|
|
Y2 Follow-up
Electronic Health Record (EHR) Data
|
0 0
|
4130 6
|
6680 6
|
|
Y2 Follow-up
COMPLETED
|
0 0
|
4729 6
|
7270 6
|
|
Y2 Follow-up
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Survey participants
Baseline characteristics by cohort
| Measure |
Total
n=3579 Participants
Total of all reporting groups
|
Early Intervention
n=1776 Participants
Counties that received the intervention first
|
Delayed Intervention
n=1803 Participants
Counties that received the intervention later
|
|---|---|---|---|
|
Race (NIH/OMB)
Year 1 · Unknown or Not Reported
|
21 Participants
n=1199 Participants • Survey participants
|
11 Participants
n=592 Participants • Survey participants
|
10 Participants
n=607 Participants • Survey participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=3579 Participants
|
0 Participants
n=1776 Participants
|
0 Participants
n=1803 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2097 Participants
n=3579 Participants
|
1044 Participants
n=1776 Participants
|
1053 Participants
n=1803 Participants
|
|
Age, Categorical
>=65 years
|
1482 Participants
n=3579 Participants
|
732 Participants
n=1776 Participants
|
750 Participants
n=1803 Participants
|
|
Sex: Female, Male
Baseline · Female
|
768 Participants
n=1191 Participants • Survey participants
|
369 Participants
n=585 Participants • Survey participants
|
399 Participants
n=606 Participants • Survey participants
|
|
Sex: Female, Male
Baseline · Male
|
423 Participants
n=1191 Participants • Survey participants
|
216 Participants
n=585 Participants • Survey participants
|
207 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1191 Participants • Survey participants
|
0 Participants
n=585 Participants • Survey participants
|
0 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · Black or African American
|
5 Participants
n=1191 Participants • Survey participants
|
2 Participants
n=585 Participants • Survey participants
|
3 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · White
|
1106 Participants
n=1191 Participants • Survey participants
|
543 Participants
n=585 Participants • Survey participants
|
563 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · More than one race
|
37 Participants
n=1191 Participants • Survey participants
|
21 Participants
n=585 Participants • Survey participants
|
16 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · Unknown or Not Reported
|
33 Participants
n=1191 Participants • Survey participants
|
14 Participants
n=585 Participants • Survey participants
|
19 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 1 · American Indian or Alaska Native
|
3 Participants
n=1199 Participants • Survey participants
|
1 Participants
n=592 Participants • Survey participants
|
2 Participants
n=607 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 1 · Asian
|
0 Participants
n=1199 Participants • Survey participants
|
0 Participants
n=592 Participants • Survey participants
|
0 Participants
n=607 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1199 Participants • Survey participants
|
0 Participants
n=592 Participants • Survey participants
|
0 Participants
n=607 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 1 · Black or African American
|
6 Participants
n=1199 Participants • Survey participants
|
3 Participants
n=592 Participants • Survey participants
|
3 Participants
n=607 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 1 · White
|
1125 Participants
n=1199 Participants • Survey participants
|
552 Participants
n=592 Participants • Survey participants
|
573 Participants
n=607 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 1 · More than one race
|
44 Participants
n=1199 Participants • Survey participants
|
25 Participants
n=592 Participants • Survey participants
|
19 Participants
n=607 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · American Indian or Alaska Native
|
14 Participants
n=1189 Participants • Survey participants
|
10 Participants
n=599 Participants • Survey participants
|
4 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · Asian
|
2 Participants
n=1189 Participants • Survey participants
|
0 Participants
n=599 Participants • Survey participants
|
2 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1189 Participants • Survey participants
|
0 Participants
n=599 Participants • Survey participants
|
0 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · Black or African American
|
5 Participants
n=1189 Participants • Survey participants
|
3 Participants
n=599 Participants • Survey participants
|
2 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · White
|
1087 Participants
n=1189 Participants • Survey participants
|
546 Participants
n=599 Participants • Survey participants
|
541 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · More than one race
|
34 Participants
n=1189 Participants • Survey participants
|
13 Participants
n=599 Participants • Survey participants
|
21 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 2 · Unknown or Not Reported
|
47 Participants
n=1189 Participants • Survey participants
|
27 Participants
n=599 Participants • Survey participants
|
20 Participants
n=590 Participants • Survey participants
|
|
Region of Enrollment
United States
|
3579 participants
n=3579 Participants
|
1776 participants
n=1776 Participants
|
1803 participants
n=1803 Participants
|
|
Ethnicity (NIH/OMB)
Year 0 · Hispanic or Latino
|
7 Participants
n=1191 Participants • Survey participants
|
3 Participants
n=585 Participants • Survey participants
|
4 Participants
n=606 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 0 · Not Hispanic or Latino
|
1178 Participants
n=1191 Participants • Survey participants
|
579 Participants
n=585 Participants • Survey participants
|
599 Participants
n=606 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 0 · Unknown or Not Reported
|
6 Participants
n=1191 Participants • Survey participants
|
3 Participants
n=585 Participants • Survey participants
|
3 Participants
n=606 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 1 · Hispanic or Latino
|
2 Participants
n=1199 Participants • Survey participants
|
0 Participants
n=592 Participants • Survey participants
|
2 Participants
n=607 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 1 · Not Hispanic or Latino
|
1185 Participants
n=1199 Participants • Survey participants
|
587 Participants
n=592 Participants • Survey participants
|
598 Participants
n=607 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 1 · Unknown or Not Reported
|
12 Participants
n=1199 Participants • Survey participants
|
5 Participants
n=592 Participants • Survey participants
|
7 Participants
n=607 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 2 · Hispanic or Latino
|
7 Participants
n=1189 Participants • Survey participants
|
5 Participants
n=599 Participants • Survey participants
|
2 Participants
n=590 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 2 · Not Hispanic or Latino
|
1122 Participants
n=1189 Participants • Survey participants
|
564 Participants
n=599 Participants • Survey participants
|
558 Participants
n=590 Participants • Survey participants
|
|
Ethnicity (NIH/OMB)
Year 2 · Unknown or Not Reported
|
60 Participants
n=1189 Participants • Survey participants
|
30 Participants
n=599 Participants • Survey participants
|
30 Participants
n=590 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · American Indian or Alaska Native
|
9 Participants
n=1191 Participants • Survey participants
|
5 Participants
n=585 Participants • Survey participants
|
4 Participants
n=606 Participants • Survey participants
|
|
Race (NIH/OMB)
Year 0 · Asian
|
1 Participants
n=1191 Participants • Survey participants
|
0 Participants
n=585 Participants • Survey participants
|
1 Participants
n=606 Participants • Survey participants
|
PRIMARY outcome
Timeframe: Y1 Follow-upPopulation: The analysis included de-identified electronic health record data from 3 Early Intervention clinics and 4 Delayed Intervention clinics during the Y1 follow-up period. Pair 1 clinics (n=4) were excluded and one Pair 2 Early Intervention clinic did not submit Y1 data. The Overall Number of Participants Analyzed represents the total number of eligible patients aged 50-74 at the analyzed clinics. The reported values are mean clinic-level CRC screening rates and not participant-level percentages.
This is the Y1 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Outcome measures
| Measure |
Early Intervention Group
n=3 Clinics
Clinics that received the multi-level intervention first
|
Delayed Intervention Group
n=4 Clinics
Clinics that received the multi-level intervention later.
|
|---|---|---|
|
CRC Screening - Clinic Level
|
47.2 Percentage of participants
Interval 14.8 to 79.5
|
44.6 Percentage of participants
Interval 13.3 to 75.9
|
PRIMARY outcome
Timeframe: Y2 Follow-upPopulation: The analysis included de-identified electronic health record data from 4 Early Intervention clinics and 4 Delayed Intervention clinics during the Y2 follow-up period. Pair 1 clinics (n=4) were excluded. The Overall Number of Participants Analyzed represents the total number of eligible patients aged 50-74 at the analyzed clinics. The reported values are mean clinic-level CRC screening rates and not participant-level percentages.
This is the Y2 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Outcome measures
| Measure |
Early Intervention Group
n=4 Clinics
Clinics that received the multi-level intervention first
|
Delayed Intervention Group
n=4 Clinics
Clinics that received the multi-level intervention later.
|
|---|---|---|
|
CRC Screening - Clinic Level
|
46.9 Percent of participants
Interval 15.2 to 78.6
|
47.7 Percent of participants
Interval 16.7 to 78.8
|
PRIMARY outcome
Timeframe: Y0 BaselinePopulation: Analysis included de-identified EHR data from 3 Early Intervention clinics and 3 Delayed Intervention clinics during the Y0 Baseline period. Pair 1 clinics (n=4) were excluded. One Early Intervention clinic and one Delayed Intervention clinics didn't contribute Y0 data. Overall Number of Participants Analyzed represents the total number of eligible patients aged 500-74 at the analyzed clinics. The reported values are mean clinic-level CRC screening rates and not participant-level percentages.
This is the baseline clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Outcome measures
| Measure |
Early Intervention Group
n=3 Clinics
Clinics that received the multi-level intervention first
|
Delayed Intervention Group
n=3 Clinics
Clinics that received the multi-level intervention later.
|
|---|---|---|
|
CRC Screening - Clinic Level
|
33.6 Percentage of participants
Interval 0.5 to 66.7
|
44.6 Percentage of participants
Interval 13.4 to 75.7
|
SECONDARY outcome
Timeframe: Y0 BaselinePopulation: The analysis population consists of randomly sampled survey participants from 6 counties in each Early and Delayed Intervention groups (12 counties total) during the Y0 Baseline period. Estimates were generated using available survey data and weighting factors to account for differential sampling and oversampling of counties and states.
Weighted estimates of clinic-level CRC screening status (within/not within CRC Screening Guidelines) among adults aged 50-74 were calculated from survey data collected in Pair 2 and Pair 3 counties. Estimates were weighted using balancing weights and county/state-level weighting factors to account for sampling design and oversampling. Reported values are weighted mean estimates with 95% confidence intervals and are not participant-level percentages.
Outcome measures
| Measure |
Early Intervention Group
n=6 Counties
Clinics that received the multi-level intervention first
|
Delayed Intervention Group
n=6 Counties
Clinics that received the multi-level intervention later.
|
|---|---|---|
|
CRC Screening - Community (County) Level
Within CRC Guidelines
|
150 Estimated Participants
Interval 135.2 to 163.5
|
218 Estimated Participants
Interval 200.3 to 233.2
|
|
CRC Screening - Community (County) Level
Not within CRC Guidelines
|
15 Estimated Participants
Interval 8.8 to 23.0
|
35 Estimated Participants
Interval 25.6 to 45.5
|
SECONDARY outcome
Timeframe: Y2 Follow-upPopulation: Analysis population consists of randomly sampled survey participants from Pair 2 and Pair 3 counties during Y2 follow-up. Weighted estimates were calculated using balancing weights and county/state level weighting factors to account for differential sampling and oversampling. Patients were randomly sampled each period, there wasn't carryover of the same participant from one period to the next. Overall Number of Participants Analyzed represents the survey sample to generate weighted estimates.
Weighted county-level estimates of CRC screening within screen guidelines among adults age 50-74. Estimates were calculated using balancing weights to account for age/sex representation within counties and county/state weighting factors to account for oversampling. Therefore, weighted estimates and confidence intervals are not restricted to the range 0-100 and should not be interpreted as raw percentages of survey participants.
Outcome measures
| Measure |
Early Intervention Group
n=4 Counties
Clinics that received the multi-level intervention first
|
Delayed Intervention Group
n=4 Counties
Clinics that received the multi-level intervention later.
|
|---|---|---|
|
CRC Screening - Community Level
Within CRC Guidelines
|
162 Estimated Participants
Interval 156.0 to 168.0
|
183 Estimated Participants
Interval 178.0 to 189.0
|
|
CRC Screening - Community Level
Not within CRC guidelines
|
184 Estimated Participants
Interval 179.0 to 189.0
|
165 Estimated Participants
Interval 159.0 to 171.0
|
SECONDARY outcome
Timeframe: Y1 Follow-upPopulation: The analysis population consists of randomly sampled survey participants from Pair 2 and Pair 3 counties during the Y1 follow-up period. Estimates were weighted using balancing weights and county/state-level weighting factors to account for differential sampling and oversampling. Because participants were independently sampled during each period, there was no carryover of participants between periods.
Weighted county-level estimates of CRC screening within screen guidelines among adults age 50-74. Estimates were calculated using balancing weights to account for age/sex representation within counties and county/state weighting factors to account for oversampling. Therefore, weighted estimates and confidence intervals are not restricted to the range 0-100 and should not be interpreted as raw percentages of survey participants.
Outcome measures
| Measure |
Early Intervention Group
n=4 Counties
Clinics that received the multi-level intervention first
|
Delayed Intervention Group
n=4 Counties
Clinics that received the multi-level intervention later.
|
|---|---|---|
|
CRC Screening - Community Level
Within CRC Guidelines
|
198 Estimated Participants
Interval 191.0 to 205.0
|
238 Estimated Participants
Interval 233.0 to 243.0
|
|
CRC Screening - Community Level
Not within CRC guidelines
|
224 Estimated Participants
Interval 219.0 to 229.0
|
207 Estimated Participants
Interval 203.0 to 211.0
|
Adverse Events
Early Intervention
Delayed Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place