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The IBD&me Randomized Controlled Trial

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合作者:
信息的提供 (责任方):
Brennan Spiegel,Cedars-Sinai Medical Center
September 26, 2018
October 4, 2018
October 4, 2018
October 15, 2018
April 15, 2019   (主要结果测量的最终数据收集日期)
Patient perception of shared decision-making[ Time Frame: 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)

与当前相同
  • Patient satisfaction[ Time Frame: one day after the clinic visit ]
    Patient satisfaction as measured by four domains of the Patient Satisfaction Questionnaire relating to communication, general satisfaction, interpersonal manner, and time spent with the doctor (PSQ-18)
  • Disease control and IBD-related quality of life[ Time Frame: at baseline and two months after the clinic visit ]
    Disease control and IBD-related quality of life, as measured by the IBD-Control questionnaire
  • Initiation or switch of a treatment[ Time Frame: at baseline and two months after the clinic visit ]
    Questionnaire about IBD therapy use
 
The IBD&me Randomized Controlled Trial
Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial

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.

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 1. 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 2. Control arm: Standardized, high-quality educational material from the Crohn's & Colitis Foundation
Interventional
N/A
分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Parallel Assignment
盲法: Interventional
盲法描述: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.
主要目的: Health Services Research
  • Other: Online decision aid called IBD&me
    Patients randomized to IBD&me will be directed to go through the website 10 days before their clinic appointment, and will be asked to bring their personalized report with them to their upcoming visit.
  • Other: Standardized educational material
    Patients randomized to the control arm will be sent a PDF file corresponding to the CCFA's online resource 10 days before their clinic appointment, and will be asked to bring it with them to their upcoming visit.
  • Experimental: Online decision aid called IBD&me
    IBD&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace. It includes an educational component and an interactive exercise with a series of ratings tasks that generates a personalized preferences report for patients to share and discuss with their physician.
  • Active Comparator: Standardized educational material
    PDF file corresponding to the CCFA's online resource on biologic therapies, which is a well-researched and clearly presented overview of IBD biologic therapies, but without an active shared-decision making component.
 
Not yet recruiting
152
与当前相同
June 15, 2019
April 15, 2019   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - 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 10 days and no later than 3 months following screening Exclusion Criteria: - Does not speak English - Does not have access to the Internet
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: Undecided
Brennan Spiegel,Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Principal Investigator: Brennan Spiegel, MD, MSHS Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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