Veteran Primers for CRC Screening
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|ClinicalTrials.gov Identifier: NCT04923646|
Recruitment Status : Completed
First Posted : June 11, 2021
Last Update Posted : May 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Primer||Not Applicable|
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different targeted outreach interventions at increasing colorectal cancer (CRC) screening rates, within the VA Puget Sound Health Care System. Average risk patients who are due for annual CRC screening (defined as aged 50-75 with no previous history of CRC, not under hospice care, and alive at the time of screening) will be identified through administrative data. All patients who are due for CRC screening will be mailed a fecal immunochemical test (FIT) kit, kit instructions, and a standard introductory letter from the primary care clinics at the VA Puget Sound. Two weeks following the mailing of the kits, patients who have not returned a kit will be identified for participation in the trial.
Patients 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 - receives no reminders,
- Arm 2 - receives a standard automated reminder phone call,
- Arm 3 - receives an automated reminder phone call with behavioral messaging,
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener.
Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Additional exploratory analyses will include sub-group analyses by race/ethnicity and reach. Enrollment in the trial will occur between March 1, 2021 and May 1, 2021.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial|
|Actual Study Start Date :||June 30, 2021|
|Actual Primary Completion Date :||January 1, 2022|
|Actual Study Completion Date :||January 19, 2022|
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
No Intervention: Control
- Return proportion [ Time Frame: 3 months ]Percent of returned FIT tests
- Return proportion [ Time Frame: 6 months ]Percent of returned FIT tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923646
|United States, Washington|
|VA Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Ashok Reddy, MD||VA Puget Sound Health Care System|
|Principal Investigator:||Stefanie Deeds, MD||VA Puget Sound Health Care System|