Reminder Modality for CRC Screening

NCT ID: NCT05012007

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-04-26

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:

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)

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control arm: No Reminder

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Automated phone reminder

Standard reminder via phone (audiocare)

Group Type EXPERIMENTAL

Reminder Phone

Intervention Type OTHER

Standard reminder via phone (audiocare)

Text reminder

Standard reminder via text (VEText)

Group Type EXPERIMENTAL

Reminder Text

Intervention Type OTHER

reminder via text (VEText)

Interventions

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Reminder Phone

Standard reminder via phone (audiocare)

Intervention Type OTHER

Reminder Text

reminder via text (VEText)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Puget Sound Health Care System

FED

Sponsor Role lead

Responsible Party

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Alaina Mori

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashok Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Stefanie Deeds, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

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VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37731137 (View on PubMed)

Other Identifiers

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FIT2

Identifier Type: -

Identifier Source: org_study_id

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