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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Automated message; Other: Opt-out scheduling

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 Type: Interventional
• Enrollment (Anticipated): 871
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanie Deeds, MD; Phone Number: 206-314-0507; Email: Stefanie.Deeds@va.gov
• Study Contact Backup: Name: Alaina Mori, MS; Phone Number: 206-247-6782; Email: Alaina.Mori@va.gov

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated phone opt-in message; Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent	Other: Automated message; Automated message via phone call (audiocare)
Experimental: Opt-out scheduling; Consult automatically sent and Veteran called to schedule screening	Other: Opt-out scheduling; Scheduling via non-automated phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mammograms completed at 100 days post randomization	Percent of mammograms completed	100 days post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mammograms scheduled at 100 days post randomization	Percent of mammograms scheduled	100 days post randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mammograms cancelled at 100 days post randomization	Percent of mammograms cancelled	100 days post randomization
Percentage of mammograms active at 100 days post randomization	Percent of mammograms active	100 days post randomization

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Anticipated): April 18, 2022
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; Cancer Screening
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MAMMoutreach

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No