IMProving Adherence to Colonoscopy Through Teams and Technology (IMPACTT)

University of California San Francisco (UCSF)

Status: Invitation-only

Conditions: Colon Cancer; Colorectal Cancer; Cancer Colorectal

Treatments: Behavioral: BPB, PIN; Behavioral: BPB, No PIN; Behavioral: No BPB, PIN; Behavioral: No BPB, No PIN

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06191185

R01CA271031 (U.S. NIH Grant/Contract)

P0555149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

2,000 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: BPB, No PIN

BPB, PIN

Experimental group

Description:

BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN).

Treatment:

Behavioral: BPB, PIN

No BPB, PIN

Experimental group

Description:

No BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN).

Treatment:

Behavioral: No BPB, PIN

No BPB, No PIN

Experimental group

Description:

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.

Treatment:

Behavioral: No BPB, No PIN