Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening

Официальное название

Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers

Обзор

The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

Подробное описание

This is a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit. A total of 400 participants will be from four FQHC clinics within the Institute for Family Health FQHC network. Participants will be randomly assigned to one of two groups:

1. eNav group (N=200) or 2. usual care group (N=200)

Participants will consent and complete a baseline questionnaire (demographics, medical information) 1-4 weeks before their primary care appointment.

Those in the intervention group will receive a link to the eNav website. The digital navigation tool includes a website and text-messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

The control group will receive standard clinical care.

Then 3-6 weeks after that primary care appointment, the research team will reach out to participants to complete a follow-up questionnaire. The follow up questionnaire will assess constructs guided by the health belief model (e.g., self-efficacy, benefits/barriers for CRC screening).

The impact of the eNav Toolkit on CRC screening completion at 6 months will be evaluated by checking their medical records. If a patient does not have a CRC screening recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.

Вмешательства

• Другое eNav
  The eNav toolkit is a digital navigation toolkit that includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
• Другое Standard of Care
  Standard of care procedures for selecting their CRC screening test.

Первичные конечные точки

• Colorectal Cancer (CRC) Screening completion [Срок оценки: End of study, at 6 months]

Вторичные конечные точки (4)

• Number of participants who complete screening tests with adequate quality [Срок оценки: End of study, at 6 months]
• Number of participants who complete the screening test with inadequate preparation [Срок оценки: End of study, at 6 months]
• Adherence to follow up recommendations [Срок оценки: End of study, at 6 months]
• The Colorectal Cancer Screening Beliefs Instrument Score [Срок оценки: Approximately 3-4 weeks after primary care appointment]

Критерии участия

Критерии включения

• Patient treated at the Institute for Family Health (IFH)
• Patient 45 to 75 years old
• English or Spanish speaking
• Able to provide consent within the study time frame (within a month of the primary care appointment
• Patients have access to a computer, tablet or mobile device to access the eNav Toolkit OR willing to use a clinic provided device, in person at either IFH OR Mount Sinai
• Patient scheduled for a primary care appointment at IFH
• Patients are due for colorectal cancer screening (as determined by the health maintenance alert in the medical chart)

Критерии исключения

• Unable to provide informed consent

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

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT06184594 · STUDY-20-01888 · R01CA248981

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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