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Behavioural Intervention

Clinic-Wide Intervention for Colorectal Cancer

N/A

Waitlist Available

Led By Folasade P May

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 6 adult care NEVHC clinic site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a program called Primary Care-Gastrointestinal Connect in a healthcare center to see if it can help more patients get follow-up colonoscopies after receiving abnormal stool test results. The

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on communication and educational interventions rather than medications or medical procedures, traditional side effects are not a concern. However, there may be indirect effects related to changes in clinic processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-intervention (1-2 years) and at the implementation midpoint (3-4 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cost-effectiveness

Implementation quality: Patient attendance: completion of a pre-colonoscopy visit

Implementation quality: Time to patient referral

+9 more

Secondary study objectives

Clinic and provider factors

Factors associated with Implementation

Follow-up colonoscopy rates

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 1Eligibility criteria met