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

NCT ID: NCT05313737

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2022-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Automated phone opt-in message

Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent

Group Type: EXPERIMENTAL

Automated message

Intervention Type: OTHER

Automated message via phone call (audiocare)

Opt-out scheduling

Consult automatically sent and Veteran called to schedule screening

Group Type: EXPERIMENTAL

Opt-out scheduling

Intervention Type: OTHER

Scheduling via non-automated phone call

Interventions

Automated message

Automated message via phone call (audiocare)

Intervention Type: OTHER

Opt-out scheduling

Scheduling via non-automated phone call

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

VA Puget Sound Health Care System

FED

Sponsor Role: lead

Responsible Party

Alaina Mori

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

Central Contacts

Stefanie Deeds, MD

Role: CONTACT

Stefanie.Deeds@va.gov

206-314-0507

Alaina Mori, MS

Role: CONTACT

Alaina.Mori@va.gov

206-247-6782

References

Marcotte LM, Deeds S, Wheat C, Gunnink E, Gray K, Rojas J, Finch C, Nelson K, Reddy A. Automated Opt-Out vs Opt-In Patient Outreach Strategies for Breast Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1187-1194. doi: 10.1001/jamainternmed.2023.4321.

Reference Type: DERIVED

PMID: 37695621 (View on PubMed)

Other Identifiers

MAMMoutreach

Identifier Type: -

Identifier Source: org_study_id