Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging

描述（由申请人提供）：幽闭恐惧症和破坏性的患者运动是MRI检查的常见障碍，但可以通过训练有素的工作人员进行非药物行为干预来预防或改善。考虑到替代方案是取消研究或给予镇静，这种干预的潜在益处是非常显著的。在美国，每年约有70万名患者无法完成核磁共振扫描。这些患者要么得不到诊断，要么面临诊断延误，要么面临药物镇静的风险，包括死亡。而成像设备通常无法在下一个预定患者之前及时填补突然空出的检查时段，从而导致可观的收入和效率损失。长期目标是提供一种有效的、临床可行的方法，通过培训MRI工作人员使用先进的融洽技巧和安慰性语言来帮助患者，以非药物方式改善幽闭恐惧症和破坏性患者的运动。第一阶段将设计并实施Comfort TalkTM训练干预的形成性评估，以便在第二阶段完成对干预的假设益处的明确测试。在具体目标1中，“安慰谈话”干预序列的设计将包括对所有设施工作人员（包括接待员、技术人员、护士和医生）进行高级融洽技巧的培训，使用基本的安慰语言，避免使用负面语言。一群有执照的医疗保健专业人员将学习如何指导患者使用脚本进行自我催眠放松技术，这些技术在放射科被发现是安全有效的。技术的设计是为了方便地集成到正常的工作流程中，而不增加时间。培训将包括在三个测试地点进行的2x8小时的现场培训。接受度、对员工行为的观察、定性反馈和不完成率将用于评估培训效果、指导原型开发和开发培训师培训材料。使用市场内试点技术，将探索利基应用及其指标，以开发特定情况的补充材料。在第二个目标中，将发展一个互动式网上电子平台，以补充培训和提供培训后支援。它将提供场景和实践应用，引导对话选项，在线直播互动课程功能，以及与智能手机的接口。该原型将由20名催眠专家进行测试，并通过用户在测试站点的输入来完善。目的3是对整个“安慰谈话”干预进行形成性评估。效果将在3个月的间隔内进行评估，并与基线表现进行比较。标准将包括接受度、定性反馈、内容掌握、员工行为、不完成率、患者回忆和满意度。通过市场探索确定的其他指标将分析其作为经济驱动力和评估工具的潜力。

DESCRIPTION (provided by applicant): Claustrophobia and disruptive patient motion are common impediments to MRI examination, but they may be prevented or ameliorated with a non-pharmacologic behavioral intervention administered by trained staff. The potential benefits of such an intervention are highly significant, considering that the alternatives are to cancel the study or administer sedation. Inability to complete their MRI scans adversely affects an estimated 700,000 patients every year in the US. These patients are either deprived of a diagnosis, subject to diagnostic delays, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities in turn, typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and thus incur considerable lost revenue and efficiency. The long-term goal is to provide a validated, clinically feasible means for non-pharmacologic amelioration of claustrophobia and disruptive patient motion, achieved by training MRI staff to use advanced rapport skills and comforting language to help patients. Phase I will design and perform a formative evaluation of a Comfort TalkTM Training intervention so that definitive testing of the hypothesized benefits for the intervention can be accomplished in Phase II. In Specific Aim 1 the Comfort TalkTM intervention sequence will be designed to include training in advanced rapport skills, using basic comforting language and avoiding negative language for all facility staff (including receptionists, technologists, nurses, and physicians). A core of licensed healthcare professionals will be taught how to guide patients in self-hypnotic relaxation techniques, using scripts, found to be safe and effective in the radiology department. Techniques are designed to easily integrate into the normal workflow without adding time. Training will include 2x8 hrs live at three test sites. Acceptance, observation of staff behavior, qualitative feedback, and rates of noncompletion will be used to assess efficacy of training, guide prototype development, and develop train-the-trainer materials. Using in-market piloting techniques, niche applications with their metrics will be explored to develop situation-specific supplemental materials. In Aim 2 an interactive web-based electronic platform will be developed to supplement training and provide post- training support. It will provide scenarios and practice applications, guided dialogue options, functions for online live interactive classes, and interface with Smartphones. The prototype will be beta-tested with 20 experts in hypnosis and refined through user input from the test sites. Aim 3 is to conduct a formative evaluation of the entire Comfort TalkTM intervention. Effects will be evaluated in 3-months intervals and compared to baseline performance. Criteria will include acceptance, qualitative feedback, content mastery, staff behavior, rates of noncompletion, patient recall and satisfaction. Additional metrics identified through in- market exploration will be analyzed for their potential as economic drivers and evaluation instruments.