Reminder Modality for CRC Screening

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Reminder Phone; Other: Reminder Text

Detailed Description

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:

1. Control arm: No reminder

   a. Intervention Type: No intervention

2. Arm 2: Automated phone reminder

   a. Intervention Type: Standard reminder via phone (audiocare)

3. 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)

• Study Type: Interventional
• Enrollment (Actual): 2653
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm: No Reminder; Usual care
Experimental: Automated phone reminder; Standard reminder via phone (audiocare)	Other: Reminder Phone; Standard reminder via phone (audiocare)
Experimental: Text reminder; Standard reminder via text (VEText)	Other: Reminder Text; reminder via text (VEText)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interim analysis	z-statistic will be calculated from the proportional difference between the combined treatment groups (all reminders) vs. control	At 50% (n = 1327) of estimated sample size

Collaborators and Investigators

• Sponsor: VA Puget Sound Health Care System
• Investigators: Principal Investigator: Ashok Reddy, MD, VA Puget Sound Health Care System; Principal Investigator: Stefanie Deeds, MD, VA Puget Sound Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; Cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: FIT2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No