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NCT Number: NCT06376565

Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Folasade P. May

PRINCIPAL_INVESTIGATOR

Jenna Alarcon

CONTACT

[email protected]

310-794-6197

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AIM 1 PATIENTS: Patients between age 45 and 75 with a HRN diagnosis in the past 5 years
  • AIM 1 PATIENTS: 12 patients who did and 12 patients who did not have surveillance colonoscopy
  • AIM 1 PROVIDERS: Primary care providers (PCPs) and gastroenterologists (GIs)
  • AIM 1 ADMINISTRATORS: Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling
  • AIM 2: Patients age 45 to 75 diagnosed with a HRN during the pre-specified two-year HRN diagnosis period

Exclusion criteria

  • AIM 2: Individuals with a personal history of colorectal carcinoma (CRC), inflammatory bowel disease (Crohn's, ulcerative colitis), or polyposis syndrome
  • AIM 2: HRN cases not confirmed by chart review (human-in-the-loop)

Treatment and study plan

Best Practice

Other

Receive standard care

Other names: standard of care, standard therapy

Communication intervention

Other

Complete clinic EHR interventions

interview

Other

Complete interview

Primary outcomes

  1. Stakeholder perspectives on the multilevel intervention (Aim 1)

    Time frame: At time of interview

    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.

  2. Completion of surveillance colonoscopy (Aim 2)

    Time frame: At 3.5 years

    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.

  3. Implementation quality (Aim 3a)

    Time frame: Up to 3 years

    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

  4. Cost effectiveness (Aim 3b)

    Time frame: Up to 3 years

    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.

Secondary outcomes

  1. Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)

    Time frame: From HRN diagnosis to colonoscopy, up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Alarcon

CONTACT

[email protected]

310-794-6197

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for High Risk Colon Polyps

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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