Colorectal Cancer, Social Determinants of Health
Conditions
Keywords
implementation science, colorectal cancer screening, social determinants of health screening
Brief summary
This work is an implementation science study that examines different aspects of implementing a single intervention. The intervention consists of asking community health centers to implement an outreach strategy to screen patients for colorectal cancer and for social determinants of health in community health centers at the same contact point. These are both clinical targets that the CHCs feel that their patients need and want to offer at a higher rate. The intervention consists of outreach to patients in need of colorectal cancer screening (CRC) to offer fecal immunochemical test (FIT) screening and screening for social determinants of health (SDOH). In this implementation science study, the intervention is an evidence-based intervention being implemented in real-world clinical practice. The intervention is the outreach to offer FIT and SDOH, conducted by clinic staff. Both evidence-based screening activities-FIT and SDOH screening-are used in the practices included in the study but pairing them is intended to increase efficiency and patient-centeredness by addressing health related social needs that may impact patients' ability to engage in cancer screening. The study aims to test the effect of implementing the intervention on clinical and process outcomes. Clinical outcomes are CRC screening and SDOH screening. Analysis of process outcomes includes measuring what organizational factors influence implementation.
Interventions
BEHAVIORALPaired 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.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This trial uses a randomized stepped wedge study design. This pragmatic design involves a sequential, randomized roll-out of the intervention across the four participating clinical sites or clusters over 8 week intervals or steps. The intervention is the paired outreach to patients in need of CRC screening to offer FIT screening and screening for SDOH. The participants who will be enrolled are CHC staff who will provide input on the implementation processes and outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Study participants include community health center staff participating in interviews about the implementation of the intervention. Up to four community health center staff members at each of the four community health centers will participate in key informant interviews twice per year. Patients will receive the paired screening intervention as part of their routine care and will not be individually recruited for the study because the intervention is being offered as part of routine care. Staff Participants Inclusion Criteria: * Staff from community health centers who facilitate screening * Age 18 and older
Exclusion criteria
* Have not participated in the implementation of the paired screening intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care | 13 pre implementation months, 14 post-implementation months | 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. |
| Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care | 13 pre implementation months, 14 post-implementation months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of FIT Kits Mailed | 4 months post-implementation, 8 months post-implementation | Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value. |
| Number of Reminders Per FIT Mailing | 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. |
| Number of Reminders Per FIT Return | 4 months post-implementation, 8 months post-implementation | Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Community health center staff are only considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Paired Screening Intervention 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. | 33,380 |
| 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. | 27,227 |
| Total | 60,607 |
Baseline characteristics
| Characteristic | Paired Screening Intervention | Total | Usual Care Control |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 6.9 | 61.5 years STANDARD_DEVIATION 6.9 | 61.6 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3644 Participants | 6832 Participants | 3188 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25184 Participants | 45720 Participants | 20536 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4552 Participants | 8055 Participants | 3503 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 83 Participants | 146 Participants | 63 Participants |
| Race (NIH/OMB) Asian | 3381 Participants | 6225 Participants | 2844 Participants |
| Race (NIH/OMB) Black or African American | 6843 Participants | 13154 Participants | 6311 Participants |
| Race (NIH/OMB) More than one race | 562 Participants | 1058 Participants | 496 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 166 Participants | 305 Participants | 139 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4733 Participants | 8693 Participants | 3960 Participants |
| Race (NIH/OMB) White | 17612 Participants | 31026 Participants | 13414 Participants |
| Sex/Gender, Customized Female | 17906 Participants | 32287 Participants | 14381 Participants |
| Sex/Gender, Customized Male | 15460 Participants | 28305 Participants | 12845 Participants |
| Sex/Gender, Customized Other | 14 Participants | 15 Participants | 1 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
Primary
Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care
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.
Time frame: 13 pre implementation months, 14 post-implementation months
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paired Screening Intervention | Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care | 0.068 Conditional odds |
| Usual Care Control | Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care | 0.028 Conditional odds |
p-value: 0.005Mixed Models Analysis
Primary
Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care
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.
Time frame: 13 pre implementation months, 14 post-implementation months
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paired Screening Intervention | Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care | 0.213 Conditional odds |
| Usual Care Control | Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care | 0.333 Conditional odds |
p-value: 0.19Mixed Models Analysis
Secondary
Number of FIT Kits Mailed
Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value.
Time frame: 4 months post-implementation, 8 months post-implementation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paired Screening Intervention | Number of FIT Kits Mailed | 4404 FIT kits |
Secondary
Number of Reminders Per FIT Mailing
Adoption measured by number of reminders per FIT mailing to patients. Data were summed to calculate a single value.
Time frame: 4 months post-implementation, 8 months post-implementation
Population: unique patients within the 4 months post-implementation, 8 months post-implementation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paired Screening Intervention | Number of Reminders Per FIT Mailing | 0.87 reminders per mailed FIT kits |
Secondary
Number of Reminders Per FIT Return
Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value.
Time frame: 4 months post-implementation, 8 months post-implementation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paired Screening Intervention | Number of Reminders Per FIT Return | 11.7 reminders per returned FIT kit |