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Clinical Trials/NCT05313737
NCT05313737
Unknown
Not Applicable

Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial

VA Puget Sound Health Care System1 site in 1 country871 target enrollmentApril 18, 2022
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
VA Puget Sound Health Care System
Enrollment
871
Locations
1
Primary Endpoint
Percentage of mammograms completed at 100 days post randomization
Last Updated
4 years ago

Overview

Brief Summary

This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening.

Detailed Description

This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different outreach strategies in improving adherence to breast cancer screening via mammography. Average risk female Veterans who are due for breast cancer screening (defined as aged 45-75 with no previous history of bilateral mastectomy, not under hospice care, and alive at the time of screening) will be identified through administrative data. Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 2 and 4) to the following interventions: Arm 1: Automated phone opt-in message Intervention Type: Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Arm 2: Opt-out scheduling Intervention Type: Consult automatically sent and Veteran called to schedule screening Randomization will be stratified within arms by prior screening status (prior screener vs. never screener). The study's primary outcome of interest is screening completion at 100 days post randomization. The study's secondary outcome of interest is screening scheduling at 100 days post randomization. Subgroup analysis aim 1 will explore whether the differences in breast cancer screening completion between investigational groups varies according to the Veterans' race/ethnicity. Subgroup analysis aim 2 will explore whether the differences in breast cancer screening scheduling between investigational groups varies according to the Veterans' race/ethnicity. Enrollment in the trial will occur between March 1, 2022 and August 31, 2022.

Registry
clinicaltrials.gov
Start Date
April 18, 2022
End Date
August 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaina Mori

Staff Physician

VA Puget Sound Health Care System

Eligibility Criteria

Inclusion Criteria

  • female Veterans aged 45-75
  • assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available
  • due for breast cancer screening (have not had a mammogram in the last 12 months)

Exclusion Criteria

  • must not be any indication of current receipt of hospice care
  • no record of recent death in the administrative data
  • not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment.
  • not have a personal history of bilateral mastectomy.

Outcomes

Primary Outcomes

Percentage of mammograms completed at 100 days post randomization

Time Frame: 100 days post randomization

Percent of mammograms completed

Secondary Outcomes

  • Percentage of mammograms scheduled at 100 days post randomization(100 days post randomization)

Study Sites (1)

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