Predicting and Addressing Colonoscopy in Safety Net Settings

Colorectal Cancer Clinical Trial

— PRECISE  

Official title:

Predicting and Addressing Colonoscopy in Safety Net Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925883
• Other study ID #: 1R01CA218923-01A1
• Secondary ID: R01CA218923
• Status: Completed
• Phase: N/A
• Start date: July 29, 2019
• Est. completion date: June 5, 2023

Study information

• Verified date: November 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. The investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. Phase II will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in Washington State.

Description:

The study will fulfill the following aims: Aim 1: Validate externally the predictive risk score using Sea Mar CHC's robust data including 29,000 patients age-eligible for colorectal cancer screening; stratify patients according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation program for the local context. Aim 2: Assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or high risk for non-adherence. Aim 3: Assess differences in the intervention arms in secondary outcomes (e.g. time to colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of intervention effectiveness (e.g. probability level, intervention dose, and patient age, ethnicity, and sex)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 5, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Positive FIT test

Exclusion Criteria:

• Prior colorectal cancer
• Dialysis patient

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Patient navigation
Receive up to 6 live phone calls with a patient navigator for education, barrier assessment, and barrier resolution to follow up colonoscopy

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	National Cancer Institute (NCI), Sea Mar Community Health Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of follow-up colonoscopy	Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result	12 months