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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-05892 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-000532 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center | |
| P30CA016042 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
I. 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.
II. 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.
III. 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.
OUTLINE: Northeast Valley Health Corporation (NEVHC) clinics are randomized to 1 of 2 arms.
ARM 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.
ARM 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | 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. |
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| Arm II (Usual care + Primary Care - GI Connect) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive clinical care consistent with current practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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/no). | At 6 months |
| 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 |
| 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. | Monthly intervals up to 3 years |
| Implementation quality: patient referral | The Investigators will measure the percent of patients who receive a referral. | Monthly intervals up to 3 years |
| Implementation quality: Time to patient referral | The Investigators will measure the time to patient referral. | Monthly intervals up to 3 years |
| 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 | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Tuan | Contact | 310-825-3181 | JTuan@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Folasade P May, MD, PhD | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Recruiting | Los Angeles | California | 90095-1406 | United States |
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| Communication Intervention | Other | Receive standardized communication from FIT QI champion |
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| Communication Intervention | Other | Receive coordination from GI liaisons |
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| Coordination | Other | Receive enhanced GI care coordination |
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| Educational Intervention | Other | Watch pre-colonoscopy educational video |
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| Electronic Health Record Review | Other | Undergo FIT result review by Primary Care FIT Tracker |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Informational Intervention | Other | Undergo generation and review of GI FIT Tracker report |
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| Informational Intervention | Other | Receive informational sheet |
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| Interview | Other | Ancillary studies |
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| Patient Navigation | Behavioral | Receive navigation from GI liaisons |
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| Referral | Other | Receive referral |
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| Referral | Other | Receive referral per standardized template |
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| Text Message-Based Navigation Intervention | Other | Receive follow-up text message |
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| Monthly intervals up to 3 years |
| Implementation quality: referral template in time to completion | The Investigators will measure the time to completion of interventions. | Monthly intervals up to 3 years |
| Implementation quality: patient education | The Investigators will measure the percent of cases in which patient education is delivered. | Monthly intervals up to 3 years |
| Implementation quality: patient education | The Investigators will measure the time to delivery of patient education when it is offered. | Monthly intervals up to 3 years |
| Implementation quality: Patient attendance: completion of a pre-colonoscopy visit | The Investigators will measure the percent of patients who complete a pre-colonoscopy visit. | Monthly intervals up to 3 years |
| Implementation quality: time to completion of a pre-colonoscopy visit | The Investigators will measure the time to completion of a pre-colonoscopy visit. | Monthly intervals up to 3 years |
| 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. | Monthly intervals up to 3 years |
| 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. | Monthly intervals up to 3 years |
| 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 |
| 0-24 months |
| Follow-up colonoscopy rates | 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/no). | At 9 months and at 12 months |
| 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) |
| 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. | Up to 3 years |
| Intervention adaptations | In qualitative interviews with stakeholders, we will learn whether there were any changes we need to be intended intervention components. | Up to 3 years |
| 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. | At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years) |
| UCLA / Jonsson Comprehensive Cancer Center | Not yet recruiting | Los Angeles | California | 90095 | United States |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D007407 | Interviews as Topic |
| D062526 | Patient Navigation |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
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