Goldstein Eliana C, Politi Mary C, Baraldi James H, Elwyn Glyn, Campos Hugo, Feng Rui, Mehta Samir, Whatley Karah, Schmitz Viktoria, Neuman Mark D
Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine in St. Louis, 660 S Euclid Ave, Campus MSC 8100-94-02, St. Louis, MO, 63110, USA.
Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, 308 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104, USA.
Implement Sci Commun. 2024 Sep 12;5(1):97. doi: 10.1186/s43058-024-00635-3.
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.
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.
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.
ClinicalTrials.gov, NCT06438640.
在美国，全身麻醉或脊髓麻醉下的髋部骨折手术是老年人的常见手术。虽然脊髓麻醉或全身麻醉对许多患者可能是合适的，并且麻醉类型的选择对偏好敏感，但麻醉医生在为该手术的患者提供麻醉咨询时，并未始终采用共同决策。我们设计了一种选项网格™ 式的沟通辅助工具“我的麻醉选择 - 髋部骨折”，以促进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有效性。
该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，随后在美国的6个地点进行该干预措施的阶梯楔形整群随机试验。主要结局将包括接受干预的符合条件患者的百分比（干预覆盖面）以及患者/临床医生沟通质量的变化（干预效果）。还将收集涉及其他RE-AIM（覆盖面、效果、采用、实施和维持）领域的次要结局。将基线数据与积极实施期的数据进行比较，然后将积极实施期与维持期的数据进行比较。实施策略由实用、稳健实施和可持续性模型（PRISM）的三个要素指导：干预措施、接受者以及实施和可持续性基础设施。
这是一项新颖的大规模试验，旨在评估和实施一种用于麻醉选择的共同决策沟通辅助工具。来自各地点负责人和专家顾问的大力支持将有助于实施的成功以及结果和干预措施的未来传播。本研究的结果将为该辅助工具在髋部骨折患者中的更广泛实施提供信息，并可能导致针对其他麻醉选择开发和实施类似的沟通辅助工具。
ClinicalTrials.gov，NCT06438640。
