IMProving Adherence to Colonoscopy Through Teams and Technology
IMPACTT
2 other identifiers
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
July 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 11, 2026
March 1, 2026
2.6 years
December 20, 2023
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months after abnormal FIT result
Secondary Outcomes (3)
Quality of bowel preparation
At time of colonoscopy procedure
Referred to GI for colonoscopy
6 weeks after abnormal FIT result
Scheduled by GI for colonoscopy
8 weeks after GI referral
Study Arms (4)
Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN)
EXPERIMENTALBPB: 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.
BPB, PIN
EXPERIMENTALBPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN).
No BPB, PIN
EXPERIMENTALNo BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN).
No BPB, No PIN
EXPERIMENTALNo 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
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.
Eligibility Criteria
You may qualify if:
- Patients with abnormal FIT result
- Patients ages 18 years or older
- English, Spanish, or Cantonese speaking
You may not qualify if:
- Patients with normal FIT result
- Patients younger than age 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
- University of California, San Franciscolead
Study Sites (1)
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (1)
Wang K, Wong J, Avilez L, Olazo K, Olanrewaju S, McCulloch CE, Pasick R, Patel S, Somsouk M, Sarkar U. Multilevel intervention for follow-up of abnormal FIT in the safety-net: IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT). Contemp Clin Trials. 2025 Mar;150:107810. doi: 10.1016/j.cct.2025.107810. Epub 2025 Jan 12.
PMID: 39809342DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Urmimala Sarkar, MD, MPH
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Ma Somsouk, MD, MAS
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2023
First Posted
January 5, 2024
Study Start
July 8, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share