N/A N=26 Randomized Screening

Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Colorectal Cancer · Social Determinants of Health

Bottom Line

View on ClinicalTrials.gov: NCT04585919 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2023

Primary outcome: Primary: Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care — 0.068; 0.028 Conditional odds — p=0.005

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paired Screening Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Harvard School of Public Health (HSPH)
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care	0.068; 0.028	0.005 sig
PRIMARY Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care	0.213; 0.333	0.19
SECONDARY Number of FIT Kits Mailed	4404	—
SECONDARY Number of Reminders Per FIT Mailing	0.87	—
SECONDARY Number of Reminders Per FIT Return	11.7	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04585919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.