Predicting and Addressing Colonoscopy in Safety Net Settings (PRECISE)

• ClinicalTrials.gov Identifier: NCT03925883
• Recruitment Status: Enrolling by invitation
• First Posted: April 24, 2019
• Last Update Posted: September 8, 2021
• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI); Sea Mar Community Health Centers
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Behavioral: Patient navigation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 732 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Predicting and Addressing Colonoscopy in Safety Net Settings
• Actual Study Start Date: July 29, 2019
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: March 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Rate of follow-up colonoscopy [ Time Frame: 12 months ]
   Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Positive FIT test

Exclusion Criteria:

• Prior colorectal cancer
• Dialysis patient

Contacts and Locations

Locations

United States, Oregon

Kaiser Permanente Center for Health Research

Portland, Oregon, United States, 97227

Sponsors and Collaborators

Kaiser Permanente

National Cancer Institute (NCI)

Sea Mar Community Health Centers

Investigators

• Principal Investigator: Gloria Coronado, PhD; Kaiser Permanente

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT03925883
• Other Study ID Numbers: 1R01CA218923-01A1 ( U.S. NIH Grant/Contract ); R01CA218923 ( U.S. NIH Grant/Contract )
• First Posted: April 24, 2019
• Last Update Posted: September 8, 2021
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:

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

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases