Trial Outcomes & Findings for Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening (NCT NCT04585919)
NCT ID: NCT04585919
Last Updated: 2023-08-01
Results Overview
Colorectal cancer screening completion by any guideline-based method. Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
13 pre implementation months, 14 post-implementation months
Results posted on
2023-08-01
Participant Flow
Study participants include community health center staff participating in interviews about the implementation of the intervention. Patients received the paired screening intervention as part of their routine care and were not individually recruited for the study because the intervention was offered as part of routine care.
Community health center staff are only considered enrolled.
Unit of analysis: Community Health Center
Participant milestones
| Measure |
Sequence A
8 months usual care, then 4 months paired outreach followed by 10 months planned adaptation.
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
Sequence B
10 months Usual care, then 4 months paired outreach, followed by 8 months planned adaptation.
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
Sequence C
12 months usual care, then 4 months paired outreach followed by 6 months planned adaptation.
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
Sequence D
14 months Usual care, then 4 months paired outreach followed by 4 months planned adaptation.
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
|---|---|---|---|---|
|
Usual Care
STARTED
|
7 1
|
6 1
|
9 1
|
4 1
|
|
Usual Care
Number of Patients
|
5947 1
|
7652 1
|
7311 1
|
6317 1
|
|
Usual Care
COMPLETED
|
7 1
|
6 1
|
9 1
|
4 1
|
|
Usual Care
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Paired Outreach
STARTED
|
7 1
|
6 1
|
9 1
|
4 1
|
|
Paired Outreach
Number of Patients
|
6453 1
|
13401 1
|
7272 1
|
6254 1
|
|
Paired Outreach
COMPLETED
|
7 1
|
6 1
|
9 1
|
4 1
|
|
Paired Outreach
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
Baseline characteristics by cohort
| Measure |
Paired Screening Intervention
n=33380 Participants
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
|
Usual Care Control
n=27227 Participants
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
Total
n=60607 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
17906 Participants
n=5 Participants
|
14381 Participants
n=7 Participants
|
32287 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
15460 Participants
n=5 Participants
|
12845 Participants
n=7 Participants
|
28305 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3644 Participants
n=5 Participants
|
3188 Participants
n=7 Participants
|
6832 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25184 Participants
n=5 Participants
|
20536 Participants
n=7 Participants
|
45720 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4552 Participants
n=5 Participants
|
3503 Participants
n=7 Participants
|
8055 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
83 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3381 Participants
n=5 Participants
|
2844 Participants
n=7 Participants
|
6225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
166 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6843 Participants
n=5 Participants
|
6311 Participants
n=7 Participants
|
13154 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17612 Participants
n=5 Participants
|
13414 Participants
n=7 Participants
|
31026 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
562 Participants
n=5 Participants
|
496 Participants
n=7 Participants
|
1058 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4733 Participants
n=5 Participants
|
3960 Participants
n=7 Participants
|
8693 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 pre implementation months, 14 post-implementation monthsPopulation: 4 Community health centers were randomized to a sequence of implementation start and each observed for an average of 2.5 control periods (stepped wedge steps) and 5.5 intervention periods (stepped wedge steps).
Colorectal cancer screening completion by any guideline-based method. Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.
Outcome measures
| Measure |
Paired Screening Intervention
n=4 health centers
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
|
Usual Care Control
n=4 health centers
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
|---|---|---|
|
Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care
|
0.068 Conditional odds
|
0.028 Conditional odds
|
PRIMARY outcome
Timeframe: 13 pre implementation months, 14 post-implementation monthsPopulation: 4 Community health centers were randomized to a sequence of implementation start and each observed for an average of 2.5 control periods (stepped wedge steps) and 5.5 intervention periods (stepped wedge steps).
Completion of social needs screening (collected as part of routine clinical care). Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.
Outcome measures
| Measure |
Paired Screening Intervention
n=4 health centers
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
|
Usual Care Control
n=4 health centers
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
|---|---|---|
|
Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care
|
0.213 Conditional odds
|
0.333 Conditional odds
|
SECONDARY outcome
Timeframe: 4 months post-implementation, 8 months post-implementationAdoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value.
Outcome measures
| Measure |
Paired Screening Intervention
n=4 health centers
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
|
Usual Care Control
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
|---|---|---|
|
Number of FIT Kits Mailed
|
4404 FIT kits
|
—
|
SECONDARY outcome
Timeframe: 4 months post-implementation, 8 months post-implementationPopulation: unique patients within the 4 months post-implementation, 8 months post-implementation
Adoption measured by number of reminders per FIT mailing to patients. Data were summed to calculate a single value.
Outcome measures
| Measure |
Paired Screening Intervention
n=4 health centers
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
|
Usual Care Control
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
|---|---|---|
|
Number of Reminders Per FIT Mailing
|
0.87 reminders per mailed FIT kits
|
—
|
SECONDARY outcome
Timeframe: 4 months post-implementation, 8 months post-implementationAdoption measured by number of reminders per FIT returned. Data were summed to calculate a single value.
Outcome measures
| Measure |
Paired Screening Intervention
n=4 health centers
Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
|
Usual Care Control
In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.
|
|---|---|---|
|
Number of Reminders Per FIT Return
|
11.7 reminders per returned FIT kit
|
—
|
Adverse Events
Paired Screening Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place