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Trial Title:
Improving Colonoscopy Surveillance for Patients with High Risk Colon Polyps
NCT ID:
NCT06376565
Condition:
Colorectal Carcinoma
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard care
Arm group label:
Arm II (Standard follow up)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Communication Intervention
Description:
Complete clinic EHR interventions
Arm group label:
Arm I(Multilevel intervention)
Intervention type:
Other
Intervention name:
Communication Intervention
Description:
Receive scheduling reminders
Arm group label:
Arm I(Multilevel intervention)
Intervention type:
Other
Intervention name:
Communication Intervention
Description:
Receive reminders and pending EHR orders
Arm group label:
Arm I(Multilevel intervention)
Intervention type:
Other
Intervention name:
Interview
Description:
Complete interview
Arm group label:
Arm I(Multilevel intervention)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Arm II (Standard follow up)
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.
Criteria for 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)
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jenna Alarcon
Phone:
310-794-6197
Email:
jcalarcon@mednet.ucla.edu
Contact backup:
Last name:
Folasade P. May
Start date:
November 8, 2023
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06376565
