[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06568016":3,"trial-entities:NCT06568016":214,"trial-summary:NCT06568016":217},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":99,"secondary_outcomes":144,"sex":165,"minimum_age":166,"maximum_age":166,"healthy_volunteers":15,"eligibility_criteria":167,"std_ages":172,"locations":176,"central_contacts":206,"overall_officials":210,"references":212,"see_also_links":213},"NCT06568016","24-000532","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","Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC","RECRUITING","2029-08-31","2026-02","2026-08-25","2024-05-29","Jonsson Comprehensive Cancer Center","OTHER",true,"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.","PRIMARY OBJECTIVES:\n\nI. 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.\n\nII. 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.\n\nIII. 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.\n\nOUTLINE: Northeast Valley Health Corporation (NEVHC) clinics are randomized to 1 of 2 arms.\n\nARM 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.\n\nARM 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.",[19],"Colorectal Carcinoma",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},1500,"ESTIMATED",[29,38,42,45,49,58,62,65,69,72,75,82,88,92],{"type":14,"name":30,"description":31,"armGroupLabels":32,"otherNames":35},"Best Practice","Receive clinical care consistent with current practice",[33,34],"Arm I (usual care)","Arm II (Usual care + Primary Care - GI Connect)",[36,37],"standard of care","standard therapy",{"type":14,"name":39,"description":40,"armGroupLabels":41},"Communication Intervention","Receive standardized communication from FIT QI champion",[33,34],{"type":14,"name":39,"description":43,"armGroupLabels":44},"Receive coordination from GI liaisons",[34],{"type":14,"name":46,"description":47,"armGroupLabels":48},"Coordination","Receive enhanced GI care coordination",[34],{"type":14,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Educational Intervention","Watch pre-colonoscopy educational video",[34],[54,55,56,57],"Education for Intervention","Intervention by Education","Intervention through Education","Intervention, Educational",{"type":14,"name":59,"description":60,"armGroupLabels":61},"Electronic Health Record Review","Undergo FIT result review by Primary Care FIT Tracker",[33,34],{"type":14,"name":59,"description":63,"armGroupLabels":64},"Ancillary studies",[33,34],{"type":14,"name":66,"description":67,"armGroupLabels":68},"Informational Intervention","Undergo generation and review of GI FIT Tracker report",[34],{"type":14,"name":66,"description":70,"armGroupLabels":71},"Receive informational sheet",[34],{"type":14,"name":73,"description":63,"armGroupLabels":74},"Interview",[33,34],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"BEHAVIORAL","Patient Navigation","Receive navigation from GI liaisons",[34],[81],"Patient Navigator Program",{"type":14,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Referral","Receive referral",[33],[87],"Referred",{"type":14,"name":83,"description":89,"armGroupLabels":90,"otherNames":91},"Receive referral per standardized template",[34],[87],{"type":14,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Text Message-Based Navigation Intervention","Receive follow-up text message",[34],[97,98],"Automated Text Message-Based Navigation","Text Message-Based Navigation",[100,104,108,111,114,117,120,123,126,128,131,134,137,140],{"measure":101,"description":102,"timeFrame":103},"Follow-up colonoscopy rates","Evaluated in patients with an abnormal fecal immunochemical test (FIT) result using electronic health record data. Will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion within 6 months (yes\u002Fno).","At 6 months",{"measure":105,"description":106,"timeFrame":107},"Implementation quality: fit tracker","The Investigators will measure the percent of cases for which the FIT tracker is used, as well as its use for each step in the process. For these measures, we will also measure time to completion.","Monthly intervals up to 3 years",{"measure":109,"description":110,"timeFrame":107},"Implementation quality: patient notification","The Investigators will measure both the percent of patients who are notified of their abnormal results as well as the time to notification.",{"measure":112,"description":113,"timeFrame":107},"Implementation quality: patient referral","The Investigators will measure the percent of patients who receive a referral.",{"measure":115,"description":116,"timeFrame":107},"Implementation quality: Time to patient referral","The Investigators will measure the time to patient referral.",{"measure":118,"description":119,"timeFrame":107},"Implementation quality: use of referral template as percent completion of interventions","The Investigators will measure the percent completion of interventions for patients at each step.",{"measure":121,"description":122,"timeFrame":107},"Implementation quality: referral template in time to completion","The Investigators will measure the time to completion of interventions.",{"measure":124,"description":125,"timeFrame":107},"Implementation quality: patient education","The Investigators will measure the percent of cases in which patient education is delivered.",{"measure":124,"description":127,"timeFrame":107},"The Investigators will measure the time to delivery of patient education when it is offered.",{"measure":129,"description":130,"timeFrame":107},"Implementation quality: Patient attendance: completion of a pre-colonoscopy visit","The Investigators will measure the percent of patients who complete a pre-colonoscopy visit.",{"measure":132,"description":133,"timeFrame":107},"Implementation quality: time to completion of a pre-colonoscopy visit","The Investigators will measure the time to completion of a pre-colonoscopy visit.",{"measure":135,"description":136,"timeFrame":107},"Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation","The Investigators will measure the percent of patients for which colonoscopy and pathology results are received at NEVHC.",{"measure":138,"description":139,"timeFrame":107},"Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over time","The Investigators will measure the time to retrieval of colonoscopy and pathology results received at NEVHC.",{"measure":141,"description":142,"timeFrame":143},"Cost-effectiveness","Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the usual care and Primary-care GI connect intervention conditions.","Up to 3 years",[145,149,152,156,159,162],{"measure":146,"description":147,"timeFrame":148},"Time to colonoscopy","The Investigators will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion.","0-24 months",{"measure":101,"description":150,"timeFrame":151},"Evaluated in patients with an abnormal FIT result using electronic health record data. Will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion within 9 months (yes\u002Fno).","At 9 months and at 12 months",{"measure":153,"description":154,"timeFrame":155},"Factors associated with Implementation","The Investigators will use the Organizational Readiness to Implement Change tool to measure responses from clinic stakeholders at each site. This is a standardized tool.","At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)",{"measure":157,"description":158,"timeFrame":143},"Reported challenges to implementation","In qualitative interviews with stakeholders and on standardized forms, we will learn about major challenges to implementation across clinics and over time. These will be qualitative data.",{"measure":160,"description":161,"timeFrame":143},"Intervention adaptations","In qualitative interviews with stakeholders, we will learn whether there were any changes we need to be intended intervention components.",{"measure":163,"description":164,"timeFrame":155},"Clinic and provider factors","The Investigators will use EHR data to measure clinic size, location, staffing, resources, number of providers, number of patients to evaluate associations with successful intervention implementation.","ALL",null,{"inclusion":168,"exclusion":170,"raw_text":171},[169],"6 adult care NEVHC clinic sites",[],"Inclusion Criteria:\n\n* 6 adult care NEVHC clinic sites",[173,174,175],"CHILD","ADULT","OLDER_ADULT",[177,195],{"facility":178,"status":8,"city":179,"state":180,"zip":181,"country":182,"contacts":183,"geoPoint":192},"University of California at Los Angeles","Los Angeles","California","90095-1406","United States",[184,189],{"name":185,"role":186,"phone":187,"email":188},"Jessica J Tuan","CONTACT","310-825-3181","jtuan@mednet.ucla.edu",{"name":190,"role":191},"Folasade P May, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":193,"lon":194},34.05223,-118.24368,{"facility":196,"status":197,"city":179,"state":180,"zip":198,"country":182,"contacts":199,"geoPoint":205},"UCLA \u002F Jonsson Comprehensive Cancer Center","NOT_YET_RECRUITING","90095",[200,204],{"name":201,"role":186,"phone":202,"email":203},"Folasade P. May","310-825-4728","fmay@mednet.ucla.edu",{"name":201,"role":191},{"lat":193,"lon":194},[207],{"name":208,"role":186,"phone":187,"email":209},"Jessica Tuan","JTuan@mednet.ucla.edu",[211],{"name":190,"affiliation":196,"role":191},[],[],{"nct_id":4,"conditions":215,"biomarkers":216},[19],[],{"nct_id":4,"found":15,"summary":218,"prompt_version":228},{"design":219,"status":220,"heading":221,"summary":222,"follow_up":223,"word_count":224,"commitments":225,"compensation":226,"drugs_mentioned":227},"This study is a pragmatic, cluster randomized trial involving 1500 patients across 6 clinics. Clinics will be randomly assigned to either the \"Primary Care-GI Connect\" program or usual care.","completed","Improving Colonoscopy Rates After Abnormal FIT Results","This study is testing a new program called \"Primary Care-GI Connect\" to help more people get a colonoscopy after an abnormal fecal immunochemical test (FIT) result. A FIT is a stool test that checks for signs of colorectal cancer. Getting a colonoscopy after an abnormal FIT is very important for finding and preventing colorectal cancer. This study compares the \"Primary Care-GI Connect\" program, which includes standardized communication, GI liaison coordination, and educational videos, to the usual care you would receive. We want to see if this new program helps more people get their colonoscopy within 6 months. The study is taking place at Federally Qualified Health Centers (FQHCs) and is open to all adults.","Your colonoscopy rates will be measured at 6 months. Implementation quality will be tracked monthly for up to 3 years.",114,"Not specified in the trial record.","Not stated in the trial record.",[46],"v2"]