Colorectal Cancer Screening Outreach

Официальное название

Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics

Обзор

This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.

Вмешательства

• Поведенческое Bundled messaging intervention
  A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.

Первичные конечные точки

• Number of participants with scheduled or completed colorectal cancer screening. [Срок оценки: up to 3 months from randomization]

Вторичные конечные точки (9)

• Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy. [Срок оценки: up to 90 days from intervention]
• Number of participants who complete screening. [Срок оценки: up to 90 days from randomization]
• Number of participants who achieve the primary endpoint. [Срок оценки: 6 months post randomization]
• Number of participants who achieve the primary endpoint by message type. [Срок оценки: up to 90 days from randomization]
• Number of participants who complete screening within 6 months of initial outreach. [Срок оценки: up to 6 months from initial outreach]
• Number of participants who complete screening colonoscopy within 6 months of initial outreach. [Срок оценки: up to 6 months from initial outreach]
• Number of participants who provide any response. [Срок оценки: 7, 14, 21, and 90 days]
• Number of participants who achieve the primary outcome from among those who did and did not respond to any text message. [Срок оценки: 6 months post randomization]
• Number of providers who respond to reminders. [Срок оценки: 6 months post randomization]

Критерии участия

Критерии включения

• Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or >1 adult medicine visits in the last year).
• Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization.

OR

• Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.

Критерии исключения

• Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Cornell Scott Hill Health — New Haven

Идентификаторы

NCT: NCT07345676 · 2000041322

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗