An interventional study of Best Practice and Communication Intervention in Colorectal Carcinoma, sponsored by Jonsson Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Screening
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 1,680 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aim 1: Participants complete an interview over 20-30 minutes. Aim 2: 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 · Other: Interview
Patients receive care according to the clinics' usual care practices.
Other: Best Practice · Other: Interview
Receive standard care
Also known as: standard of care, standard therapy
Complete clinic EHR interventions
Receive scheduling reminders
Receive reminders and pending EHR orders
Complete interview
Ancillary studies
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.
Time frame: At time of interview
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.
Time frame: At 3.5 years
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
Time frame: Up to 3 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.
Time frame: Up to 3 years
Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)
Time frame: From HRN diagnosis to colonoscopy, up to 3 years
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Jonsson Comprehensive Cancer Center