Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 871
- 试验地点
- 2
- 主要终点
- Percentage of mammograms completed at 100 days post randomization
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Percentage of mammograms completed at 100 days post randomization
时间窗: 100 days post randomization
Percent of mammograms completed
次要结局
- Percentage of mammograms scheduled at 100 days post randomization(100 days post randomization)
研究者
Alaina Mori
Staff Physician
VA Puget Sound Health Care System