Opt-in vs. Opt-out for Breast Cancer Screening

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: Automated message; Other: Opt-out scheduling

• Registration Number: NCT05313737
• Lead Sponsor: VA Puget Sound Health Care System

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.

Study Timeline

• Study First Submitted: 2022-02-01
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Study Start: 2022-04-18
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 871

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated phone opt-in message	Automated message	Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent
Opt-out scheduling	Opt-out scheduling	Consult automatically sent and Veteran called to schedule screening

Primary Outcome Measures

Name	Time	Method
Percentage of mammograms completed at 100 days post randomization	100 days post randomization	Percent of mammograms completed

Secondary Outcome Measures

Name	Time	Method
Percentage of mammograms scheduled at 100 days post randomization	100 days post randomization	Percent of mammograms scheduled

Trial Locations

Locations (1)

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States