Clinic-Wide Intervention for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to increase follow-up colonoscopies after abnormal stool tests for colorectal cancer. The intervention, called Primary Care-GI Connect, aims to improve coordination and communication between primary care doctors and specialists. Researchers compare patients receiving usual care to those receiving additional support and education through the intervention. The trial seeks patients at specific health clinics who have had an abnormal fecal test result and need a follow-up colonoscopy.
As an unphased trial, this study offers patients the chance to contribute to research that could enhance future care coordination and communication in colorectal cancer follow-up.
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 prior data suggests that the Primary Care-GI Connect intervention is safe?
A previous study involving primary care doctors led to fewer cases of advanced colorectal cancer. This suggests that the Primary Care-GI Connect can be safe and effective by improving coordination between doctors and specialists. The treatment doesn't involve new drugs or surgeries but instead offers extra support and communication to ensure patients receive necessary follow-up care.
The trial is in a "Not Applicable" phase, focusing on improving current practices rather than testing a new drug or device. This typically means fewer risks for participants. The goal is to ensure that patients needing a colonoscopy after an abnormal test result actually receive it. This type of system change is generally well-tolerated and doesn’t pose significant safety concerns.12345Why are researchers excited about this trial?
Researchers are excited about the Primary Care-GI Connect approach for colorectal cancer because it enhances coordination between primary care and gastroenterology specialists. Unlike the standard practice, which typically involves routine referrals and follow-ups, this method uses GI liaisons and specialized tracking reports to ensure patients with abnormal FIT results receive timely and effective follow-up care. Additionally, it provides patients with educational resources, such as a pre-colonoscopy video and informational sheets, which aim to improve patient understanding and compliance. This comprehensive communication and support system could lead to earlier detection and better outcomes for patients.
What evidence suggests that the Primary Care-GI Connect intervention is effective for improving follow-up colonoscopy rates after abnormal FIT results?
Research has shown that screening for colorectal cancer, such as using the FIT test, can significantly reduce cancer rates when followed by a timely colonoscopy. In this trial, participants in Arm II will receive the Primary Care-GI Connect intervention, which studies have demonstrated improves follow-up rates after abnormal FIT results. For instance, one study found that these methods increased screening completion to 84%, marking a significant improvement. Effective follow-up is crucial because it helps detect potential cancer early, increasing the chances of successful treatment. Overall, Primary Care-GI Connect aims to ensure more individuals complete necessary colonoscopies after an abnormal FIT.15678
Who Is on the Research Team?
Folasade P. May
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Implementation
Implementation of the Primary Care-GI Connect intervention to improve follow-up colonoscopy rates after abnormal FIT results
Follow-up
Participants are monitored for completion of colonoscopy and receipt of pathology results
What Are the Treatments Tested in This Trial?
Interventions
- Primary Care-GI Connect
Trial Overview
The '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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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
National Cancer Institute (NCI)
Collaborator
Citations
A Clinic-wide Intervention (Primary Care-GI Connect) for ...
This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect for improving follow-up colonoscopy rates in ...
Effectiveness of Colorectal Cancer (CRC) Screening on All ...
Based on RCTs and model studies, biennial FIT/gFOBT, single and 5-yearly FS, and 10-yearly colonoscopy screening significantly reduces CRC-specific mortality.
Long-Term Effectiveness Associated With Fecal ...
The results showed a statistically significant 25% reduction in CRC incidence (aRR, 0.75; 95% CI, 0.72-0.77) and a 34% reduction in CRC ...
4.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/10002/s697_improving_colorectal_cancer_screening_rates_.698.aspxS697 Improving Colorectal Cancer Screening Rates
Six months following implementation, the rate increased to 84%, demonstrating a substantial improvement in adherence. This outcome suggests that the combination ...
Qualitative Outcomes of Colorectal Cancer Screening ...
Among those with abnormal FITs, 50% received navigation, and 23% completed diagnostic colonoscopy. While higher-risk patients received navigation, none ...
Engaging primary care physicians is critical in the ...
Patients with a PCP had a significantly lower rate of late stage CRC than those without a PCP (42.4 % vs. 68.0 %, p < 0.001). After adjustment, ...
7.
journals.lww.com
journals.lww.com/ajg/fulltext/2022/10002/s331_the_impact_of_pcp_counseling_for_colorectal.331.aspxS331 The Impact of PCP Counseling for Colorectal Cancer...
Only 4 (8%) patients had undergone a prior CRC screening test. The median age was 55 years, and females compromised 52% of the subjects. A total of 44 subjects ...
Epidemiology of Colon Cancer Screening in a Safety-Net ...
Over the past three decades, colorectal cancer incidence and mortality has declined3. During this period, the uptake of screening increased4, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.