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Predicting and Addressing Colonoscopy in Safety Net Settings

Predicting and Addressing Colonoscopy in Safety Net Settings

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03925883
Acronym
PRECISE
Enrollment
1200
Registered
2019-04-24
Start date
2019-07-29
Completion date
2023-06-05
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screening, Cancer screening, Risk prediction model, Patient navigation, Colonoscopy

Brief 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.

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)

Interventions

BEHAVIORALPatient navigation

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Sea Mar Community Health Centers
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Positive FIT test

Exclusion criteria

* Prior colorectal cancer * Dialysis patient

Design outcomes

Primary

MeasureTime frameDescription
Rate of follow-up colonoscopy12 monthsReceipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026