Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

• Sponsor: Harvard School of Public Health (HSPH) (Other)
• Overall Status: Completed
• CT.gov ID: NCT04585919
• Collaborator: National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 26
• Locations: 4
• Arms: 2
• Actual Duration (Months): 15.8
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Social Determinants of Health	Behavioral: Paired Screening Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• 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.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)
• Primary Purpose: Screening
• Official Title: Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paired Screening Intervention	Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Change in number of patients screened for CRC [13 pre implementation months, 14 post-implementation months]

   Return of FIT kit within 3 months (collected as part of routine clinical care)

2. Change in number of patients screened for SDOH [13 pre implementation months, 14 post-implementation months]

   Completion of social needs screening (collected as part of routine clinical care)

Secondary Outcome Measures

1. Number of FIT kits mailed [4 months post-implementation, 8 months post-implementation]

   Adoption measured by number of FIT kits mailed to patients

2. 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

3. Number of reminders per FIT return [4 months post-implementation, 8 months post-implementation]

   Adoption measured by number of reminders per FIT returned

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbor Health Services	Boston	Massachusetts	United States	02122
2	Brockton Neighborhood Health Center	Brockton	Massachusetts	United States	02301
3	Lowell Community Health Center	Lowell	Massachusetts	United States	01854
4	Manet Community Health Center	Quincy	Massachusetts	United States	02171

Sponsors and Collaborators

• Harvard School of Public Health (HSPH)
• National Institutes of Health (NIH)
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Karen Emmons, PhD, Harvard TH Chan School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen Emmons, Professor of Social and Behavioral Sciences, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT04585919
• Other Study ID Numbers: 67702115; P50CA244433
• First Posted: Oct 14, 2020
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karen Emmons, Professor of Social and Behavioral Sciences, Harvard School of Public Health (HSPH): implementation science; colorectal cancer screening; social determinants of health screening
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Apr 28, 2022