Predicting and Addressing Colonoscopy in Safety Net Settings (PRECISE)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Patient navigation

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Positive FIT test

Exclusion Criteria:

• Prior colorectal cancer
• Dialysis patient

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient Navigation; Patients randomized to this arm will receive patient navigation with the goal of completing a follow-up colonoscopy within 12 months of a positive FIT result.	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
No Intervention: Usual Care; Patients will receive usual care screening opportunities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of follow-up colonoscopy	Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result	12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI); Sea Mar Community Health Centers
• Investigators: Principal Investigator: Gloria Coronado, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• Coronado GD, Kihn-Stang A, Slaughter MT, Petrik AF, Thompson JH, Rivelli JS, Jimenez R, Gibbs J, Yadav N, Mummadi RR. Follow-up colonoscopy after an abnormal stool-based colorectal cancer screening result: analysis of steps in the colonoscopy completion process. BMC Gastroenterol. 2021 Sep 28;21(1):356. doi: 10.1186/s12876-021-01923-1.
• Coronado GD, Johnson ES, Leo MC, Schneider JL, Smith D, Mummadi R, Petrik AF, Thompson JH, Jimenez R. Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers. Contemp Clin Trials. 2020 Feb;89:105920. doi: 10.1016/j.cct.2019.105920. Epub 2019 Dec 24.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; Colorectal cancer screening; Patient navigation; Cancer screening; Risk prediction model
• 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: 1R01CA218923-01A1 (U.S. NIH Grant/Contract); R01CA218923 (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