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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Automated message
* Other: Opt-out scheduling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Screening, Adherence