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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-02090 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA271034 | 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 tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.
PRIMARY OBJECTIVE:
I. To increase completion of surveillance colonoscopy within 3.5 years of high risk neoplasia (HRN) diagnosis.
OUTLINE:
AIM 1: Participants complete an interview over 20-30 minutes.
AIM 2: Primary care clinics are randomized to 1 of 2 arms.
ARM I: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records. Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record. Patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center.
ARM II: Patients receive care according to the clinics' usual care practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I(Multilevel intervention) | Experimental | Aim 1: Participants complete an interview over 20-30 minutes. Aim 2: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records (EHR). Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record. Patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center. |
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| Arm II (Standard follow up) | Active Comparator | Patients receive care according to the clinics' usual care practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard care |
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| Measure | Description | Time Frame |
|---|---|---|
| Stakeholder perspectives on the multilevel intervention (Aim 1) | The Investigators will conduct 1-on-1 in-depth interviews with patients, advocates, providers, and administrators. these interviews will provide data in closer proximity to intervention implementation to optimize composition, timing, and acceptability of each component. Interview content is guided by the multiple health outcomes framework (MHOF) and addresses major barriers (patient, provider, system) to surveillance and challenges (patient, provider, system) to the planned implementation of intervention components. | At time of interview |
| Completion of surveillance colonoscopy (Aim 2) | Will analyze rates during the study period using a generalized linear mixed model with a logit link that includes an indicator for study arm and random effects for clinic and primary care provider to account for the multilevel data structure. | At 3.5 years |
| Implementation quality (Aim 3a) | The Investigators will assess implementation quality and outcomes through stakeholder interviews (patients, providers, administrators) and chart reviews. The information gained will guide adaptations of the intervention for future use so that clinicians maximize effectiveness, feasibility, acceptability, sustainability, and impact. Findings will also determine the resources needed to successfully scale the intervention to different settings | Up to 3 years |
| Cost effectiveness (Aim 3b) | Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the natural language processing-based electronic health record intervention compared to usual care office outreach. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) | From HRN diagnosis to colonoscopy, up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Alarcon | Contact | 310-794-6197 | JCAlarcon@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Folasade P May | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41260460 | Derived | May FP, McEwan JA, Tuan JJ, Crespi CM, Maehara CK, Yang JO, Uy A, Gupta S, Kang Y, Myint A, Naini BV, Elmore JG, Kadiyala S, Ong MK, Bui AAT, Hamilton AB, Chang LC, Gelvezon A, Hsu W, Bastani R. Increasing timely colonoscopy surveillance for patients with high-risk colorectal polyps: Protocol for a cluster randomized trial. Contemp Clin Trials. 2026 Jan;160:108147. doi: 10.1016/j.cct.2025.108147. Epub 2025 Nov 17. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Communication Intervention | Other | Complete clinic EHR interventions |
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| Communication Intervention | Other | Receive scheduling reminders |
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| Communication Intervention | Other | Receive reminders and pending EHR orders |
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| Interview | Other | Complete interview |
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| Interview | Other | Ancillary studies |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |