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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29772 participants

Primary outcome timeframe

Y1 Follow-up

Results posted on

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

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

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-up

Population: 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

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-up

Population: 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

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 Baseline

Population: 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

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 Baseline

Population: 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

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-up

Population: 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

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-up

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Intervention

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

Mark Dignan, PhD, MPH

University of Kentucky

Phone: 859-323-4708

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place