IMProving Adherence to Colonoscopy Through Teams and Technology

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.
• Поведенческое No BPB, No PIN
  Patient-level: standard communication from their care team.

Первичные конечные точки

• Colonoscopy completion [Срок оценки: 6 months after abnormal FIT result]

Вторичные конечные точки (3)

• Quality of bowel preparation [Срок оценки: At time of colonoscopy procedure]
• Referred to GI for colonoscopy [Срок оценки: 6 weeks after abnormal FIT result]
• Scheduled by GI for colonoscopy [Срок оценки: 8 weeks after GI referral]

Критерии участия

Критерии включения

• Patients with abnormal FIT result
• Patients ages 18 years or older
• English, Spanish, or Cantonese speaking

Критерии исключения

• Patients with normal FIT result
• Patients younger than age 18

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Zuckerberg San Francisco General Hospital — San Francisco

Публикации

• 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 39809342

Идентификаторы

NCT: NCT06191185 · P0555149 · R01CA271031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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