An interventional study of BPB, No PIN and BPB, PIN in Colon Cancer, Cancer Colorectal and Colorectal Cancer, sponsored by University of California, San Francisco. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Diagnostic
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.
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.
1,433 studies on the registry are indexed under Colonic Neoplasms; 358 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: BPB, No PIN
BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN).
Behavioral: BPB, PIN
No BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN).
Behavioral: No BPB, 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.
Behavioral: No 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.
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.
Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS.
Patient-level: standard communication from their care team.
Colonoscopy completion
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
Time frame: 6 months after abnormal FIT result
Quality of bowel preparation
The quality of procedure preparation is defined as excellent, good, fair, and poor.
Time frame: At time of colonoscopy procedure
Referred to GI for colonoscopy
After an abnormal FIT result, providers should review the test result, communicate with patients, and refer the patient to GI to complete a colonoscopy.
Time frame: 6 weeks after abnormal FIT result
Scheduled by GI for colonoscopy
After an abnormal FIT result, providers will refer patients. The electronic referral is reviewed by GI, who will call the patient to schedule the colonoscopy.
Time frame: 8 weeks after GI referral
Plan to share: No
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University of California, San Francisco