Colorectal Carcinoma
Conditions
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.
Interventions
OTHERBest Practice
Receive standard care
OTHERCommunication Intervention
Complete clinic EHR interventions
OTHERInterview
Complete interview
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stakeholder perspectives on the multilevel intervention (Aim 1) | At time of interview | 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. |
| Completion of surveillance colonoscopy (Aim 2) | At 3.5 years | 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. |
| Implementation quality (Aim 3a) | Up to 3 years | 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 |
| Cost effectiveness (Aim 3b) | Up to 3 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) | From HRN diagnosis to colonoscopy, up to 3 years |
Countries
United States
Contacts
Primary ContactJenna Alarcon
Outcome results
None listed