Reminder Modality for CRC Screening
Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial
1 other identifier
interventional
2,653
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Aug 2021
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedFirst Posted
Study publicly available on registry
August 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2022
CompletedMay 4, 2022
May 1, 2022
7 months
June 22, 2021
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of returned FIT Kits
the return rate at three months post randomization
three months post randomization
Secondary Outcomes (1)
Percentage of returned FIT Kits
six months post randomization
Other Outcomes (1)
Interim analysis
At 50% (n = 1327) of estimated sample size
Study Arms (3)
Control arm: No Reminder
NO INTERVENTIONUsual care
Automated phone reminder
EXPERIMENTALStandard reminder via phone (audiocare)
Text reminder
EXPERIMENTALStandard reminder via text (VEText)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Related Publications (1)
Deeds S, Schuttner L, Wheat C, Gunnink E, Geyer J, Beste L, Chen A, Dominitz JA, Nelson K, Reddy A. Automated Reminders Enhance Mailed Fecal Immunochemical Test Completion Among Veterans: a Randomized Controlled Trial. J Gen Intern Med. 2024 Jan;39(1):113-119. doi: 10.1007/s11606-023-08409-8. Epub 2023 Sep 20.
PMID: 37731137DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashok Reddy, MD
VA Puget Sound Health Care System
- PRINCIPAL INVESTIGATOR
Stefanie Deeds, MD
VA Puget Sound Health Care System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
June 22, 2021
First Posted
August 19, 2021
Study Start
August 1, 2021
Primary Completion
March 1, 2022
Study Completion
April 26, 2022
Last Updated
May 4, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share