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

Mount Sinai Health System

Status: Invitation-only

Conditions: Colorectal Cancer Screening

Treatments: Other: eNav; Other: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06184594

STUDY-20-01888

R01CA248981 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 211 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Unable to provide informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups, including a placebo group

eNav intervention

Experimental group

Description:

Subjects assigned to this arm will receive a link to the eNav website.

Treatment:

Other: eNav

Usual Care Group

Placebo Comparator group

Description:

Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care.

Treatment:

Other: Standard of Care