Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Sponsors

Lead Sponsor: Harvard School of Public Health

Collaborator: National Institutes of Health (NIH)
National Cancer Institute (NCI)

Source Harvard School of Public Health
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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date September 2023
Primary Completion Date September 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in CRC screening 13 pre implementation months, 14 post-implementation months
Change in SDOH screening 13 pre implementation months, 14 post-implementation months
Enrollment 32
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Paired Screening Intervention

Description: 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.

Arm Group Label: Paired Screening Intervention

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Karen Emmons, PhD Principal Investigator Harvard TH Chan School of Public Health
Overall Contact

Last Name: Project Manager

Phone: 6173848915

Email: [email protected]

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Harvard School of Public Health

Investigator Full Name: Karen Emmons

Investigator Title: Professor of Social and Behavioral Sciences

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Paired Screening Intervention

Type: Experimental

Label: Usual Care Control

Type: No Intervention

Description: 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.

Patient Data Yes
Study Design Info

Intervention Model: Sequential Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov