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Clinical Trials/NCT05012007
NCT05012007
Completed
Not Applicable

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

VA Puget Sound Health Care System1 site in 1 country2,653 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
VA Puget Sound Health Care System
Enrollment
2653
Locations
1
Primary Endpoint
Percentage of returned FIT Kits
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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)

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
April 26, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaina Mori

Staff Physician

VA Puget Sound Health Care System

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of returned FIT Kits

Time Frame: three months post randomization

the return rate at three months post randomization

Secondary Outcomes

  • Percentage of returned FIT Kits(six months post randomization)

Study Sites (1)

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