Colorectal Cancer Clinical Trial
Official title:
Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
Verified date | July 2023 |
Source | Harvard School of Public Health (HSPH) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health (HSPH) | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
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 |
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