Clinical trial NCT06191185: IMProving Adherence to Colonoscopy Through Teams and Technology
Official title: IMProving Adherence to Colonoscopy Through Teams and Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Cancer Colorectal
Colorectal Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-01-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colonoscopy completion
timeFrame: 6 months after abnormal FIT result
Secondary outcomes:
measure: Quality of bowel preparation
timeFrame: At time of colonoscopy procedure
measure: Referred to GI for colonoscopy
timeFrame: 6 weeks after abnormal FIT result
measure: Scheduled by GI for colonoscopy
timeFrame: 8 weeks after GI referral
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Urmimala Sarkar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Ma Somsouk, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: