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

Study Overview
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Brief Summary
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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
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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) 1-2 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 3-4 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.

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

Conditions
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Colorectal Cancer Screening

Intervention / Treatment
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* Other: eNav
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient treated at the Institute for Family Health (IFH) Patient eligible for CRC screening -- Guideline recommended age to be screened for CRC (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 devise 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eNav intervention<br>Subjects assigned to this arm will receive a link to the eNav website. | Other: eNav<br>* 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).<br>|
| Placebo Comparator: Usual Care Group<br>Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care. | Other: Standard of Care<br>* Standard of care procedures for selecting their CRC screening test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer (CRC) Screening completion | Colonoscopy completion, 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. | End of study, at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete screening tests with adequate quality | The number of participants who complete the screening test (i.e., colonoscopy, FIT or FIT-DNA) with adequate quality. Test quality will be coded as inadequate if the test needs to be repeated or cannot be resulted due to inadequate quality (e.g., poor bowel prep, inadequate stool sample). | End of study, at 6 months | 
| Number of participants who complete the screening test with inadequate preparation | The number of participants who complete the screening test and the preparation is inadequate (e.g., poor bowel prep quality, inadequate stool sample collection). | End of study, at 6 months | 
| Adherence to follow up recommendations | Record if the study participant is following the colorectal cancer screening recommendations after the colonoscopy procedure has been completed. Measured as: Yes = participant completed the recommended follow up No = participant did NOT complete the recommended follow up In process = the recommended follow up does not fall within the 6-month time frame Missing = data not available in the medical chart | End of study, at 6 months | 
| The Colorectal Cancer Screening Beliefs Instrument Score | The assessments specifically measure the following Health Belief Model scales: Perceived Benefits of Stool-based Tests: min 3 - max 15 Perceived Benefits of Colonoscopy: min 3 - max 15 Perceived Susceptibility: min 2 - max 10 Perceived Barriers of Stool-Based Tests: min 7 - max 35 Perceived Barriers of Colonoscopy: min 9 - max 45 Perceived Self-Efficacy of Stool-based Tests: min 8 - max 40 Perceived Self-Efficacy of Colonoscopy: min 12 - max 60 Perceive Severity: min 3 - max 15 Total scores range 47-235, with higher scores indicate higher levels of the scale (e.g., higher scores = more barriers, more benefits, higher perceived susceptibility of CRC, higher levels of self-efficacy). | Approximately 3-4 weeks after primary care appointment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Screening, Federally Qualified Health Centers, Digital Patient Navigation Toolkit