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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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