Colorectal Cancer
Conditions
Brief summary
This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.
Interventions
BEHAVIORALMulti-level intervention to increase CRC screening
Intervention for the community, providers, patients, clinics and systems
Sponsors
Mark Dignan, PhD
National Cancer Institute (NCI)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Primary care clinics randomized to usual care do not receive intervention materials or attention
Intervention model description
Primary care clinics randomized to intervention or usual care
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* age 50-74 * all races, sexes and genders * resident of the study area
Exclusion criteria
.no exclusions based on gender, race or ethnicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRC Screening - Clinic Level | Y1 Follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRC Screening - Community (County) Level | Y0 Baseline | 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. |
| CRC Screening - Community Level | Y2 Follow-up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark B Dignan, PhD
University of Kentucky
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1482 Participants |
| Age, Categorical Between 18 and 65 years | 1053 Participants |
| Ethnicity (NIH/OMB) Year 0 Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Year 0 Not Hispanic or Latino | 1178 Participants |
| Ethnicity (NIH/OMB) Year 0 Unknown or Not Reported | 3 Participants |
| Ethnicity (NIH/OMB) Year 1 Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Year 1 Not Hispanic or Latino | 1185 Participants |
| Ethnicity (NIH/OMB) Year 1 Unknown or Not Reported | 7 Participants |
| Ethnicity (NIH/OMB) Year 2 Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Year 2 Not Hispanic or Latino | 558 Participants |
| Ethnicity (NIH/OMB) Year 2 Unknown or Not Reported | 60 Participants |
| Race (NIH/OMB) Year 0 American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Year 0 Asian | 0 Participants |
| Race (NIH/OMB) Year 0 Black or African American | 3 Participants |
| Race (NIH/OMB) Year 0 More than one race | 37 Participants |
| Race (NIH/OMB) Year 0 Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Year 0 Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) Year 0 White | 1106 Participants |
| Race (NIH/OMB) Year 1 American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Year 1 Asian | 0 Participants |
| Race (NIH/OMB) Year 1 Black or African American | 3 Participants |
| Race (NIH/OMB) Year 1 More than one race | 25 Participants |
| Race (NIH/OMB) Year 1 Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Year 1 Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) Year 1 White | 1125 Participants |
| Race (NIH/OMB) Year 2 American Indian or Alaska Native | 10 Participants |
| Race (NIH/OMB) Year 2 Asian | 2 Participants |
| Race (NIH/OMB) Year 2 Black or African American | 3 Participants |
| Race (NIH/OMB) Year 2 More than one race | 21 Participants |
| Race (NIH/OMB) Year 2 Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Year 2 Unknown or Not Reported | 47 Participants |
| Race (NIH/OMB) Year 2 White | 1087 Participants |
| Region of Enrollment United States | 1803 participants |
| Sex: Female, Male Baseline Female | 369 Participants |
| Sex: Female, Male Baseline Male | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed