A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial

Official title

PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions

Overview

This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.

GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse.

After completion of study intervention, patients are followed up for 18 months.

Interventions

• Other Best Practice
  Receive usual care CRC screening program navigation
• Other Educational Intervention
  Receive QR code and link to video addressing fears of colonoscopy
• Other Electronic Health Record Review
  Ancillary studies
• Other Interview
  Ancillary studies
• Other Supportive Care
  Receive rideshare transportation home after colonoscopy
• Other Survey Administration
  Ancillary studies

Primary outcome measures

• Rate of colonoscopy completion within 6 months [Time frame: At 6 months after randomization]
• Time to colonoscopy completion [Time frame: Beginning 6 months after randomization until study completion]

Secondary outcome measures (12)

• Rate of colonoscopy completion > 6 months [Time frame: At 9 and 12 months after randomization]
• Colonoscopy referral: Number of participants referred for a colonoscopy [Time frame: Up to 18 months after randomization]
• Time to colonoscopy referral (days) [Time frame: Up to 18 months after randomization]
• Number of participants who schedule a colonoscopy [Time frame: Up to 18 months after randomization]
• Time to scheduling a colonoscopy (days) [Time frame: Up to 18 months after randomization]
• Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion [Time frame: Up to 18 months after randomization]
• Rates of colorectal cancer or advanced adenoma [Time frame: Up to 18 months after randomization]
• Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach) [Time frame: 6-24 months post randomization]
• Perception that the intervention components are suitable to address identified barriers (Acceptability) [Time frame: 6-24 months post randomization]
• Degree to which the intervention is used as intended (Fidelity) [Time frame: 6-24 months post randomization]
• Average cost per patient to deliver the intervention [Time frame: Weekly, for up to 8 months]
• Average cost per clinic to deliver the intervention [Time frame: Weekly, for up to 8 months]

Eligibility criteria

Inclusion criteria

• PATIENTS: Age >= 45 years old and =< 75 years old
• PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic
• PATIENTS: >= 1 month from documented abnormal FIT result
• PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment
• CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care
• CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)/UW Medicine Population Health Program that provide colorectal cancer screening and navigation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

United States · 1 center

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT06822530 · RG1124701 · NCI-2024-08639 · R37CA295618 · FHIRB0020712

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗