Clinic-Wide Intervention for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Jessica Tuan

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 5 6 7 8}

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

6 adult care NEVHC clinic sites

Timeline for a Trial Participant

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

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?

Group I: Arm II (Usual care + Primary Care - GI Connect) Experimental Treatment 10 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 Control 5 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.

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06568016

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10093633/

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.

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2835051

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.aspx

S697 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 ...

5. mdpi.com mdpi.com/2072-6694/17/21/3590

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10792257/

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.aspx

S331 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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000914

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, ...