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Clinical Trials/NCT06191185
NCT06191185Enrolling By InvitationNot Applicable

IMProving Adherence to Colonoscopy Through Teams and Technology

University of California, San Francisco1 site in 1 country2,000 target enrollmentStarted: July 8, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
2,000
Locations
1
Primary Endpoint
Colonoscopy completion

Study Overview

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.

Detailed Description

Follow-up colonoscopy after abnormal stool-based colorectal cancer screening (e.g., fecal immunochemical test (FIT)) results in early detection of colorectal cancer (CRC), prevention of CRC, and reduction in CRC mortality. FIT is a commonly utilized screening test that can be performed at home, is inexpensive, scalable, and often adopted in health systems where colonoscopy resources are scarce. Despite evidence that timely colonoscopy is necessary after an abnormal FIT result, completion of colonoscopy occurs in less than 50% of patients at 6 months and varies significantly by clinic and health systems. In addition to understanding the meaning of an abnormal FIT, three care transitions must occur smoothly for the patient: colonoscopy referral, scheduling, and attendance. However, multilevel factors influence missed follow-up, and multilevel solutions are needed along the care continuum to address clinic-, provider-, and patient-level factors that impair or delay colonoscopy completion.

IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT), proposes to close gaps and reduce disparities in CRC screening by improving the completion of diagnostic colonoscopy following abnormal FIT in vulnerable populations using a multilevel approach consisting of interventions at the clinic-, provider- and patient-level. The specific aims are 1) to evaluate the effect of a clinic-level intervention targeting primary care providers and staff to adopt "best practices" to support colonoscopy completion in patients with abnormal FIT results, 2) to determine the effect of a patient-level technology intervention with enhanced instructions and navigation for patients with abnormal FIT to complete a diagnostic colonoscopy, and 3) to explore the multilevel implementation factors contributing to intervention outcomes using mixed methods.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Diagnostic
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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

Experimental

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.

Intervention: BPB, No PIN (Behavioral)

BPB, PIN

Experimental

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

PIN: enhanced patient instructions and navigation (PIN).

Intervention: BPB, PIN (Behavioral)

No BPB, PIN

Experimental

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

PIN: enhanced patient instructions and navigation (PIN).

Intervention: No BPB, PIN (Behavioral)

No BPB, No PIN

Experimental

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.

Intervention: No BPB, No PIN (Behavioral)

Outcomes

Primary Outcomes

Colonoscopy completion

Time Frame: 6 months after abnormal FIT result

Wait time for routine colonoscopy is often less than 6 weeks and less than 2 weeks if one is willing to take an afternoon appointment. Completion of colonoscopy will be captured by extracting pertinent colonoscopy elements

Secondary Outcomes

  • Scheduled by GI for colonoscopy(8 weeks after GI referral)
  • Referred to GI for colonoscopy(6 weeks after abnormal FIT result)
  • Quality of bowel preparation(At time of colonoscopy procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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