Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890054
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2021-05-12
Brief Title:
Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings SMARTER CRC
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings SMARTER CRC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMARTER CRC
Brief Summary:
This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer CRC on the United states population This study may improve colorectal cancer screening rates follow-up colonoscopy and referral to care in rural Medicaid patients
Detailed Description:
PRIMARY OBJECTIVE
I Adapt pilot then test the implementation and scale-up of targeted direct mail and patient navigation programs
OUTLINE
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening Eligible patients will be mailed a fecal immunochemical test FIT The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic Outcomes are tracked using reports from direct mail vendors claims data from participating Medicaid health plans clinic data from the electronic health record chart review and data from a REDCap database The hypotheses will be tested using a two-arm cluster randomized trial design Participating clinics will be randomized into two groups Intervention and Usual Care Medicaid health plans Coordinated care organizations CCO and clinic leadership participate in interviews and complete surveys
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months Data will be collected at 6 time points baseline 6-months 12-months 18-months 24-months and 36-months
Implementation outcomes and adaptations will be evaluated through interviews with clinic staff patients and CCO partners Clinic staff in various roles related to the program eg outreach workers patient navigators quality improvement leads complete surveys and participate in interviews and observations at baseline 6-9 months post-implementation and at approximately 12 months later to assess clinichealth system level factors that may influence outcomes Patients participate in interviews to explore patient experiences with the program Regional and Organizational partners CCO leaders endoscopy providers eg gastrointestinal specialists general surgeons primary care clinicians and community organizations also participate in interviews
I Adapt pilot then test the implementation and scale-up of targeted direct mail and patient navigation programs
OUTLINE
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening Eligible patients will be mailed a fecal immunochemical test FIT The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic Outcomes are tracked using reports from direct mail vendors claims data from participating Medicaid health plans clinic data from the electronic health record chart review and data from a REDCap database The hypotheses will be tested using a two-arm cluster randomized trial design Participating clinics will be randomized into two groups Intervention and Usual Care Medicaid health plans Coordinated care organizations CCO and clinic leadership participate in interviews and complete surveys
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months Data will be collected at 6 time points baseline 6-months 12-months 18-months 24-months and 36-months
Implementation outcomes and adaptations will be evaluated through interviews with clinic staff patients and CCO partners Clinic staff in various roles related to the program eg outreach workers patient navigators quality improvement leads complete surveys and participate in interviews and observations at baseline 6-9 months post-implementation and at approximately 12 months later to assess clinichealth system level factors that may influence outcomes Patients participate in interviews to explore patient experiences with the program Regional and Organizational partners CCO leaders endoscopy providers eg gastrointestinal specialists general surgeons primary care clinicians and community organizations also participate in interviews
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-01032 | REGISTRY | None | None |
| STUDY00020681 | OTHER | None | None |
| UH3CA244298 | NIH | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchUH3CA244298 |