Clinical trial NCT06376565: Improving Colonoscopy Surveillance for Patients with High Risk Colon Polyps
Official title: Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for High Risk Colon Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-04-19
Enrollment: 1680
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility 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)

Primary outcomes:
measure: Stakeholder perspectives on the multilevel intervention (Aim 1)
timeFrame: At time of interview
measure: Completion of surveillance colonoscopy (Aim 2)
timeFrame: At 3.5 years
measure: Implementation quality (Aim 3a)
timeFrame: Up to 3 years
measure: Cost effectiveness (Aim 3b)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)
timeFrame: From HRN diagnosis to colonoscopy, up to 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Folasade P May
role: PRINCIPAL_INVESTIGATOR
References: