IMProving Adherence to Colonoscopy Through Teams and Technology

Colorectal Cancer Clinical Trial

— IMPACTT  

Official title:

IMProving Adherence to Colonoscopy Through Teams and Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06191185
• Other study ID #: P0555149
• Secondary ID: R01CA271031
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Kristan Olazo, MPH
• Phone: 925-642-6177
• Email: kristan.olazo[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Colorectal
• Colon Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• 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.
• BPB, PIN
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.
• No BPB, PIN
Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS.
• No BPB, No PIN
Patient-level: standard communication from their care team.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of bowel preparation	The quality of procedure preparation is defined as excellent, good, fair, and poor.	At time of colonoscopy procedure
Secondary	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.	6 weeks after abnormal FIT result
Secondary	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.	8 weeks after GI referral