Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Study Overview
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Brief Summary
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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.

Official Title
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Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Conditions
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Colorectal Cancer, Social Determinants of Health

Intervention / Treatment
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* Behavioral: Paired Screening Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paired Screening Intervention<br> | Behavioral: Paired Screening Intervention<br>* 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.<br>|
| No Intervention: Usual Care Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 13 pre implementation months, 14 post-implementation months | 
| 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. | 13 pre implementation months, 14 post-implementation months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of FIT Kits Mailed | Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value. | 4 months post-implementation, 8 months post-implementation | 
| 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. | 4 months post-implementation, 8 months post-implementation | 
| Number of Reminders Per FIT Return | Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value. | 4 months post-implementation, 8 months post-implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation science, colorectal cancer screening, social determinants of health screening