NCT03925883: PRECISE

Predicting and Addressing Colonoscopy in Safety Net Settings

Completed NA Last updated 29 April 2024

What this trial tests

NA trial testing Patient navigation in Colorectal Cancer in 1,200 participants. Completed in 5 June 2023.

Timeline

29 July 2019

Primary endpoint
5 June 2023

5 June 2023

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	screening
Enrollment	1,200
Start date	29 July 2019
Primary completion	5 June 2023
Estimated completion	5 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Patient navigation

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Kaiser Permanente — full company profile →

Who can join

Adults 50 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.
   Coronado GD, Johnson ES, Leo MC, Schneider JL, et al · · 2020 · cited 16× · PMID 31881390 · DOI 10.1016/j.cct.2019.105920
2. Follow-up colonoscopy after an abnormal stool-based colorectal cancer screening result: analysis of steps in the colonoscopy completion process.
   Coronado GD, Kihn-Stang A, Slaughter MT, Petrik AF, et al · · 2021 · cited 13× · PMID 34583638 · DOI 10.1186/s12876-021-01923-1
3. Patient Navigation to Improve Colonoscopy Completion After an Abnormal Stool Test Result : A Randomized Controlled Trial.
   Coronado GD, Petrik AF, Thompson JH, Leo MC, et al · · 2025 · cited 7× · PMID 40163863 · DOI 10.7326/annals-24-01885
4. The recalibration and redevelopment of a model to calculate patients' probability of completing a colonoscopy following an abnormal fecal test.
   Petrik AF, Johnson ES, Slaughter M, Leo MC, et al · · 2024 · cited 1× · PMID 37661831 · DOI 10.1177/09691413231195568
5. Implementing a successful patient navigation program for follow-up colonoscopy: Lessons from the PRECISE study.
   Thompson JH, Schneider JL, Rivelli JS, Gautom P, et al · · 2026 · PMID 41849281 · DOI 10.1371/journal.pone.0343659
6. Acceptability of Patient Navigation to Promote Follow-up Colonoscopy.
   Schneider JL, Rivelli JS, Vaughn KA, Thompson JH, et al · · 2024 · PMID 41766920 · DOI 10.5993/ajhb.48.3.8