Opt-in vs. Opt-out for Breast Cancer Screening
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Percentage of mammograms completed at 100 days post randomization [100 days post randomization]
Percent of mammograms completed
Secondary Outcome Measures
- Percentage of mammograms scheduled at 100 days post randomization [100 days post randomization]
Percent of mammograms scheduled
Other Outcome Measures
- Percentage of mammograms cancelled at 100 days post randomization [100 days post randomization]
Percent of mammograms cancelled
- Percentage of mammograms active at 100 days post randomization [100 days post randomization]
Percent of mammograms active
Eligibility Criteria
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:
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must not be any indication of current receipt of hospice care
-
no record of recent death in the administrative data
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not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment.
-
not have a personal history of bilateral mastectomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAMMoutreach