Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Colorectal Cancer Clinical Trial

Official title:

Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585919
• Other study ID #: 67702115
• Secondary ID: P50CA244433
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 25, 2022

Study information

• Verified date: July 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Social Determinants of Health

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.

Locations

Country	Name	City	State
United States	Harbor Health Services	Boston	Massachusetts
United States	Brockton Neighborhood Health Center	Brockton	Massachusetts
United States	Lowell Community Health Center	Lowell	Massachusetts
United States	Manet Community Health Center	Quincy	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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