Refining, implementing, and evaluating an anesthesia choice conversation aid for older adults with hip fracture: protocol for a stepped wedge cluster randomized trial.

Eliana C Goldstein, Mary C Politi, James H Baraldi, Glyn Elwyn, Hugo Campos, Rui Feng, Samir Mehta, Karah Whatley, Viktoria Schmitz, Mark D Neuman
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引用次数: 0

Abstract

Background: Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice.

Methods: The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure.

Discussion: This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices.

Trial registration: ClinicalTrials.gov, NCT06438640.

完善、实施和评估针对髋部骨折老年人的麻醉选择谈话辅助工具:阶梯楔形群随机试验方案。
背景:在全身或脊髓麻醉下进行髋部骨折手术是美国老年人的常见手术。尽管脊髓麻醉或全身麻醉对许多患者来说都是合适的,而且麻醉类型的选择对患者的偏好很敏感,但麻醉医师在为患者提供有关该手术麻醉的咨询时并没有坚持使用共同决策。我们设计了一个选项网格(Option Grid™)式对话辅助工具 "我的麻醉选择─髋部骨折",以促进在这种互动中的共同决策。本研究将完善该辅助工具,并评估其在临床实践中的实施情况和效果:研究将分两个阶段进行:对相关临床医生和患者进行定性访谈以完善辅助工具,然后在美国的 6 个机构对干预措施进行阶梯式楔形分组随机试验。主要结果将包括接受干预的合格患者比例(干预覆盖率)和患者/临床医生沟通质量的变化(干预效果)。此外,还将收集针对其他 RE-AIM(覆盖范围、有效性、采用、实施和维持)领域的次要结果。结果将在基线数据和积极实施期之间进行比较,然后在积极实施期和维持期之间进行比较。实施策略将以实用、稳健实施和可持续性模型(PRISM)中的三个结构为指导:干预、接受者以及实施和可持续性基础设施:讨论:这是一项新颖的大规模试验,对麻醉选择的共同决策对话辅助工具进行了评估和实施。研究机构领导和专家顾问的大力支持将有助于实施的成功以及未来结果和干预措施的推广。这项研究的结果将为在髋部骨折患者中更广泛地实施这种辅助工具提供信息,并能促进为其他麻醉选择开发和实施类似的对话辅助工具:试验注册:ClinicalTrials.gov,NCT06438640。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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CiteScore
4.20
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