Clincosm LogoSign in Get a demo

Veteran Primers for CRC Screening

Sponsor
VA Puget Sound Health Care System (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT04923646
Collaborator
(none)
2,404
Enrollment
1
Location
2
Arms
6.7
Actual Duration (Months)
360.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized controlled trial to evaluate the effectiveness of targeted outreach reminder strategies for a population-based, mailed, fecal immunochemistry test kit (FIT) screening program at the VA Puget Sound among average risk patients who are due for annual colorectal cancer (CRC) screening.

Condition or Disease Intervention/Treatment Phase
  • Other: Primer
 N/A

Detailed Description

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:

  1. Control arm - receives no reminders,

  2. Arm 2 - receives a standard automated reminder phone call,

  3. 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 Design

Study Type:
Interventional
Actual Enrollment :
2404 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Screening
Official Title:
Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial
Actual Study Start Date :
Jun 30, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active

Primer

Other: Primer
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
No Intervention: Control

No Primer

Outcome Measures

Primary Outcome Measures

  1. Return proportion [3 months]

    Percent of returned FIT tests

Secondary Outcome Measures

  1. Return proportion [6 months]

    Percent of returned FIT tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion criteria:

  • Veteran

  • 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 colorectal (CRC) screening

Exclusion criteria:

  • Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.

  • Not currently receiving hospice care

  • No record of recent death in the administrative data.

  • No history of CRC or history of prior colectomy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Puget Sound Health Care System Seattle Washington United States 98108

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alaina Mori, Staff Physician, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT04923646
Other Study ID Numbers:
  • FIT1
First Posted:
Jun 11, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alaina Mori, Staff Physician, VA Puget Sound Health Care System
Cancer screening
Behavioral economics
Adherence
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of May 6, 2022