Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568016
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Clinic-wide Intervention Primary Care-GI Connect for Improving Rates of Colonoscopy After Abnormal Fecal Immunochemical Test Result in Patients at Federally Qualified Health Centers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal GI Connect for improving follow-up colonoscopy rates in patients at a Federally Qualified Health Center FQHC who have an abnormal fecal immunochemical test FIT result Colorectal cancer screening reduces colorectal cancer incidence and mortality but is underutilizedThe most accessible feasible and common colorectal cancer screening modality for average-risk individuals in low resource settings such as FQHCs is the stool-based FIT However the benefit of FIT screening on colorectal cancer risk is realized only if individuals with abnormal FIT results undergo timely follow-up colonoscopy Follow-up colonoscopy rates are low and there are many barriers to follow-up colonoscopy in safety net settings such as FQHCs Effective interventions that are multi-component and improve care coordination are needed to improve abnormal FIT follow-up rates in FQHCs The Primary Care-GI Connect intervention includes components that enhance care coordination standardize the referral process and engage both primary care and specialist physicians This clinic-wide intervention may improve rates of follow-up colonoscopy after abnormal FIT results in patients seen at FQHCs
Detailed Description:
PRIMARY OBJECTIVES
I Conduct a pragmatic cluster randomized trial in 6 clinics 1500 patients within a multi-site FQHC system to compare the effectiveness of the multilevel FQHC-GI care coordination intervention Primary Care-GI Connect 3 clinics 750 patients to the usual care condition 3 clinics 750 patients on receipt of a colonoscopy within 6 months of an abnormal FIT
II Systematically assess the quality of intervention implementation to understand the feasibility and relative importance of intervention elements as guided by the Multilevel Health Outcomes Framework
III Measure the incremental cost-effectiveness of the Primary Care-GI Connect intervention compared to usual care to understand the potential value feasibility and potential for dissemination
OUTLINE Northeast Valley Health Corporation NEVHC clinics are randomized to 1 of 2 arms
ARM I Patients receive clinical care consistent with current practice at NEVHC Patients have their electronic health records EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT quality improvement QI champions about their results and receive a referral to gastroenterology
ARM II Patients receive clinical care consistent with current practice at NEVHC as described in Arm I Patients also receive enhanced GI care coordination from GI liaisons who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result
I Conduct a pragmatic cluster randomized trial in 6 clinics 1500 patients within a multi-site FQHC system to compare the effectiveness of the multilevel FQHC-GI care coordination intervention Primary Care-GI Connect 3 clinics 750 patients to the usual care condition 3 clinics 750 patients on receipt of a colonoscopy within 6 months of an abnormal FIT
II Systematically assess the quality of intervention implementation to understand the feasibility and relative importance of intervention elements as guided by the Multilevel Health Outcomes Framework
III Measure the incremental cost-effectiveness of the Primary Care-GI Connect intervention compared to usual care to understand the potential value feasibility and potential for dissemination
OUTLINE Northeast Valley Health Corporation NEVHC clinics are randomized to 1 of 2 arms
ARM I Patients receive clinical care consistent with current practice at NEVHC Patients have their electronic health records EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT quality improvement QI champions about their results and receive a referral to gastroenterology
ARM II Patients receive clinical care consistent with current practice at NEVHC as described in Arm I Patients also receive enhanced GI care coordination from GI liaisons who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None