Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Interview; Other: Interview; Other: Best Practice; Other: Communication Intervention; Other: Communication Intervention; Other: Communication Intervention

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
• Enrollment (Estimated): 1680
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center
      • Principal Investigator: Folasade P. May
      • Contact: Folasade P. May; Phone Number: 617-620-7806; Email: FMAY@MEDNET.UCLA.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aim 1 (Interview); Participants complete an interview over 20-30 minutes.	Other: Interview; Complete interview; Other: Interview; Ancillary studies
Active Comparator: Aim 2, Arm II (Standard follow up); Patients receive care according to the clinics' usual care practices.	Other: Interview; Complete interview; Other: Interview; Ancillary studies; Other: Best Practice; Receive standard care; Other Names: standard of care; standard therapy
Experimental: Aim 2, Arm I (Multilevel intervention); 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.	Other: Communication Intervention; Complete clinic EHR interventions; Other: Communication Intervention; Receive scheduling reminders; Other: Communication Intervention; Receive reminders and pending EHR orders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)	From HRN diagnosis to colonoscopy, up to 3 years

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Folasade P May, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 5, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 22-000647; NCI-2024-02090 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA271034 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No