1500 Participants Needed

Clinic-Wide Intervention for Colorectal Cancer

Recruiting at 1 trial location
JT
Overseen ByJessica Tuan
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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 underutilized.The 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Primary Care-GI Connect for colorectal cancer?

Research shows that primary care can improve colorectal cancer outcomes by increasing screening rates and early diagnosis, which are crucial for better survival. Additionally, interventions in primary care settings, like physician recommendations and providing test kits, have been effective in increasing screening completion.12345

How is the Primary Care-GI Connect treatment for colorectal cancer different from other treatments?

The Primary Care-GI Connect treatment is unique because it focuses on improving colorectal cancer screening rates through a clinic-wide intervention in primary care settings, rather than directly treating the cancer itself. This approach emphasizes increasing early detection and prevention by enhancing the collaboration between primary care and gastrointestinal specialists.678910

Research Team

FP

Folasade P. May

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients at Federally Qualified Health Centers with abnormal fecal immunochemical test results, indicating potential colorectal cancer. It aims to improve follow-up colonoscopy rates, which are crucial for early detection and treatment.

Inclusion Criteria

6 adult care NEVHC clinic sites

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the Primary Care-GI Connect intervention to improve follow-up colonoscopy rates after abnormal FIT results

Up to 3 years
Monthly intervals

Follow-up

Participants are monitored for completion of colonoscopy and receipt of pathology results

9-12 months

Treatment Details

Interventions

  • Primary Care-GI Connect
Trial OverviewThe 'Primary Care-GI Connect' intervention is being tested to see if it can increase the rate of follow-up colonoscopies after an abnormal FIT result. This includes enhanced care coordination, standardized referrals, and engaging primary care and GI specialists.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (Usual care + Primary Care - GI Connect)Experimental Treatment10 Interventions
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.
Group II: Arm I (usual care)Active Control5 Interventions
Patients receive clinical care consistent with current practice at NEVHC. Patients have their EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT QI champions about their results and receive a referral to gastroenterology.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

References

Primary care utilization and colorectal cancer outcomes among Medicare beneficiaries. [2022]
Validation of a diagnostic prediction tool for colorectal cancer: a case-control replication study. [2023]
Primary care practice organization influences colorectal cancer screening performance. [2023]
Testing Interventions to Motivate and Educate (TIME): A multi-level intervention to improve colorectal cancer screening. [2020]
FOBT completion in FQHCs: impact of physician recommendation, FOBT information, or receipt of the FOBT kit. [2022]
Tailored navigation in colorectal cancer screening. [2022]
Cross-sectional survey study of primary care clinics on evidence-based colorectal cancer screening intervention use. [2023]
Factors That Support Sustainability of Health Systems Change to Increase Colorectal Cancer Screening in Primary Care Clinics: A Longitudinal Qualitative Study. [2023]
Correlates of colorectal cancer screening rates in primary care clinics serving low income, medically underserved populations. [2021]
A qualitative exploration of the role of primary care in supporting colorectal cancer patients. [2021]