Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Colorectal Cancer (CRC) Screening completion
Study Overview
Brief Summary
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).
Detailed 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:
- eNav group (N=200) or
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
eNav intervention
Subjects assigned to this arm will receive a link to the eNav website.
Intervention: eNav (Other)
Usual Care Group
Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care.
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
Colorectal Cancer (CRC) Screening completion
Time Frame: End of study, at 6 months
CRC, Yes/No Medical chart review will determine whether the CRC screening was complete. If a patient does not have a CRC screening result recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.
Secondary Outcomes
- Number of participants who complete screening tests with adequate quality(End of study, at 6 months)
- Number of participants who complete the screening test with inadequate preparation(End of study, at 6 months)
- Adherence to follow up recommendations(End of study, at 6 months)
- The Colorectal Cancer Screening Beliefs Instrument Score(Approximately 3-4 weeks after primary care appointment)
Investigators
Sarah Miller
Assistant Professor
Icahn School of Medicine at Mount Sinai