Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 4
- 主要终点
- Differences in decision regret between treatment groups
研究概览
简要总结
The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.
详细描述
The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study was designed to develop and test the use of ACA as part of routine clinical care for women diagnosed with AUB. After pilot testing, the ACA survey is administered in this study where patients are assigned to receive the ACA or to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have received a diagnosis of dysfunctional or abnormal uterine bleeding (AUB) that is recommended for treatment
- •Have not yet selected or initiated treatment for current AUB diagnosis
- •Be at least 18 years of age.
- •Be possible candidates for either medical or surgical therapy
- •Able to provide informed consent for treatment options for oneself
排除标准
- •Are currently being treated for cancer
- •Any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer)
- •AUB due to serious pelvic pathology, medications, pregnancy or systemic disease that limits their range of treatment options
- •Are not recommended for surgical intervention
- •Are not recommended for medical intervention
- •Are under 18 years of age
- •Have not received a diagnosis of AUB
- •Are currently being treated for AUB
结局指标
主要结局
Differences in decision regret between treatment groups
时间窗: 6 weeks
Decision regret is measured by the Decision Regret Scale
Differences in patient-reported satisfaction between treatment groups
时间窗: 6 weeks
Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)
次要结局
未报告次要终点
研究者
Lisa Hess
Assistant Professor of Medicine and Public Health
Indiana University