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NCT06376565 | RECRUITING | Colorectal Carcinoma

Improving Colonoscopy Surveillance for Patients with High Risk Colon Polyps
Sponsor:

Jonsson Comprehensive Cancer Center

Brief Summary:

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.

Condition or disease

Colorectal Carcinoma

Intervention/treatment

Best Practice

Communication Intervention

Communication Intervention

Communication Intervention

Interview

Interview

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1680 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for High Risk Colon Polyps
Actual Study Start Date : 2023-11-08
Estimated Primary Completion Date : 2027-11-30
Estimated Study Completion Date : 2027-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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)
Improving Colonoscopy Surveillance for Patients with High Risk Colon Polyps

Location Details

NCT06376565

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How to Participate

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Locations

RECRUITING

United States, California

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095