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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated phone opt-in message | Experimental | Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent |
|
| Opt-out scheduling | Experimental | Consult automatically sent and Veteran called to schedule screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated message | Other | Automated message via phone call (audiocare) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of mammograms completed at 100 days post randomization | Percent of mammograms completed | 100 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of mammograms scheduled at 100 days post randomization | Percent of mammograms scheduled | 100 days post randomization |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
female only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Deeds, MD | Contact | 206-314-0507 | Stefanie.Deeds@va.gov | |
| Alaina Mori, MS | Contact | 206-247-6782 | Alaina.Mori@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ashok Reddy, MD | VA Puget Sound Health Care System | Principal Investigator |
| Stefanie Deeds, MD | VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37695621 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Opt-out scheduling |
| Other |
Scheduling via non-automated phone call |
|
| 100 days post randomization |
| D017437 |
| Skin and Connective Tissue Diseases |