Reminder Modality for CRC Screening

Study Overview
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Brief Summary
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This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.

Detailed Description
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This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual CRC screening. Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6) to the following interventions: Control arm: No reminder a. Intervention Type: No intervention Arm 2: Automated phone reminder a. Intervention Type: Standard reminder via phone (audiocare) Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText) Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Official Title
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Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Reminder Phone
* Other: Reminder Text


Participation Criteria
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Eligibility Criteria
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Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request. Inclusion Criteria: Veterans assigned to a primary care provider at the VA Puget Sound as of January 1, 2021 At least 1 year of prior data available (evidence of at least one outpatient visit). Due for annual CRC screening Exclusion Criteria: Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment. No indication of current receipt of hospice care or record of recent death in the administrative data. No personal history of CRC or history of prior colectomy.

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm: No Reminder<br>Usual care | |
| Experimental: Automated phone reminder<br>Standard reminder via phone (audiocare) | Other: Reminder Phone<br>* Standard reminder via phone (audiocare)<br>|
| Experimental: Text reminder<br>Standard reminder via text (VEText) | Other: Reminder Text<br>* reminder via text (VEText)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of returned FIT Kits | the return rate at three months post randomization | three months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of returned FIT Kits | the return rate at six months post randomization | six months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer screening, Adherence