Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376565
• Other study ID #: 22-000647
• Secondary ID: NCI-2024-02090R0
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 5, 2024
• Est. completion date: March 2028

Study information

• Verified date: April 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1680
• Est. completion date: March 2028
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Best Practice
Receive standard care
• Communication Intervention
Complete clinic EHR interventions
• Communication Intervention
Receive scheduling reminders
• Communication Intervention
Receive reminders and pending EHR orders
• Interview
Complete interview
• Interview
Ancillary studies

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)		From HRN diagnosis to colonoscopy, up to 3 years