Clinical trial NCT04585919: Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
Official title: Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Social Determinants of Health
Keywords: implementation science
colorectal cancer screening
social determinants of health screening
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2020-10-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: 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.


Eligibility 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

Primary outcomes:
measure: Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care
timeFrame: 13 pre implementation months, 14 post-implementation months
measure: Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care
timeFrame: 13 pre implementation months, 14 post-implementation months
Secondary outcomes:
measure: Number of FIT Kits Mailed
timeFrame: 4 months post-implementation, 8 months post-implementation
measure: Number of Reminders Per FIT Mailing
timeFrame: 4 months post-implementation, 8 months post-implementation
measure: Number of Reminders Per FIT Return
timeFrame: 4 months post-implementation, 8 months post-implementation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harbor Health Services
state: Massachusetts
city: Brockton
country: United States
facility: Brockton Neighborhood Health Center
state: Massachusetts
city: Lowell
country: United States
facility: Lowell Community Health Center
state: Massachusetts
city: Quincy
country: United States
facility: Manet Community Health Center
state: Massachusetts
Study officials:
affiliation: Harvard TH Chan School of Public Health
name: Karen Emmons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aschbrenner KA, Kruse G, Emmons KM, Singh D, Barber-Dubois ME, Miller AM, Thomas AN, Bartels SJ. Stakeholder and Equity Data-Driven Implementation: a Mixed Methods Pilot Feasibility Study. Prev Sci. 2024 Apr;25(Suppl 1):136-146. doi: 10.1007/s11121-022-01442-9. Epub 2022 Oct 4.