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Not recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06191185

Conditions

Colon Cancer

Cancer Colorectal

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

BPB, No PIN

BPB, PIN

No BPB, PIN

No BPB, No PIN

Study Details

Brief summary:

Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.

Conditions

Colon Cancer

Cancer Colorectal

Colorectal Cancer

Study ID

NCT06191185

Start date

Jul 8, 2024

Status verified date

Jul, 2024

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients with abnormal FIT result
  • Patients ages 18 years or older
  • English, Spanish, or Cantonese speaking

Exclusion Criteria:

  • Patients with normal FIT result
  • Patients younger than age 18

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN)

BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication.

No PIN: Patients will receive usual communication from their care team.

experimental: BPB, PIN

BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication.

PIN: enhanced patient instructions and navigation (PIN).

experimental: No BPB, PIN

No BPB: Clinic's usual practice after a patient receives an abnormal FIT result.

PIN: enhanced patient instructions and navigation (PIN).

experimental: No BPB, No PIN

No BPB: Clinic's usual practice after a patient receives an abnormal FIT result.

No PIN: Patients will receive usual communication from their care team.

Interventions

BPB, No PIN

Patient-level: standard communication from care team.

Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.

BPB, PIN

Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the short messaging service (SMS) text messaging platform, HealthySMS.

Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.

No BPB, PIN

Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS.

No BPB, No PIN

Patient-level: standard communication from their care team.

Primary outcome measure

  • Colonoscopy completion [ Time Frame: 6 months after abnormal FIT result ]

Central Contacts and Locations

Central contacts

Kristan Olazo, MPH

925-642-6177kristan.olazo@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Kristan Olazo

kristan.olazo@ucsf.edu

Principal Investigator:

Urmimala Sarkar, MD, MPH

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 10, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2024-07-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.