Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Patient perceptions of shared decision-making
研究概览
简要总结
Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.
The principal objective of this study is to assess the impact of an online decision aid called IBD&me on patient perceptions of shared-decision making as compared to a standardized education arm.
详细描述
Context: Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.
Objective
The principal objective of this study is to assess the impact of an online decision aid called IBD&me on patient perceptions of shared-decision making as compared to a standardized education arm.
Hypothesis
IBD&me, through optimizing shared-decision making (SDM) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an SDM tool.
Design: Pragmatic multicenter randomized controlled trial in IBD outpatient care
- Intervention: IBD&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace
- Control arm: Standardized, high-quality educational material from the Crohn's & Colitis Foundation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Given the study design and intervention, it is not possible to ensure the blinding of patients and physicians. However, we will attempt to address the limitations resulting from a lack of blinding:
- Patients and the physicians will be informed of the study protocol, but will not be provided accurate information about the specific primary outcome (i.e. comparison between IBD&me and the Crohn's & Colitis Foundation of America (CCFA) resource). The informed consent document will keep participants blind to the study goals.
- Physicians will be kept blinded of the patient's assignment group until the clinic visit.
- Data will be collected by an independent researcher. Study investigators and the data analyst will remain blinded until all follow-up data is obtained and the primary analysis is finalized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Have ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or inflammatory bowel disease unclassified (IBD-U)
- •Have experienced IBD related symptoms in the 30 days before screening
- •Considering discussing biologic therapies for controlling his or her IBD at the next clinic visit
- •Have an IBD-related visit scheduled at least 7 days and no later than 3 months following screening
排除标准
- •Does not speak English
- •Does not have access to the Internet
结局指标
主要结局
Patient perceptions of shared decision-making
时间窗: one day after the clinic visit
To assess the impact of the IBD\&me decision aid on patient perceptions of shared decision-making, compared to a standardized education arm. Patient perception of shared decision-making, as measured by the 9-item Shared Decision-Making Questionnaire (SDM-Q-9)
次要结局
- Patient satisfaction(one day after the clinic visit)
- Patient perceptions of decisional conflict(one day after the clinic visit)
- Disease control and IBD-related quality of life(at baseline and two months after the clinic visit)
- Initiation or switch of a treatment(at baseline and two months after the clinic visit)
研究者
Brennan Spiegel
Director, Health Services Research
Cedars-Sinai Medical Center