PAtient-centered mUltidiSciplinary care for vEterans undergoing surgery (PAUSE): a hybrid 1 clinical effectiveness-implementation intervention trial

背景：虚弱是一种与术后较高的生理储备减少相关的综合征。 死亡率和不良后果。我们的初步工作表明，在机构范围内进行脆弱性筛查和 引入“手术前暂停”可将6个月的死亡率降低三倍。然而，知识鸿沟存在于 干预的性质以及哪些利益相关者应参与“术前停顿”。 复杂患者的多学科护理模式在肿瘤学、伤口护理和初级护理方面非常有效 关心。我们提出了一种新的干预措施，即以患者为中心的多学科护理 外科(暂停)，来自不同领域的专家将为外科决策和 优化高危退伍军人的结局。 影响：老年退伍军人是一个快速增长的人口，对高质量的外科护理有很大的需求。这 研究将建立一个结构化的多学科工作流程，以改善临床和质量结果，并提供 根据退伍军人管理局的优先事项为虚弱和高风险退伍军人提供符合其目标和期望的高价值护理。 创新：这是退伍军人管理局实施外科护理多学科护理模式的第一项研究。这个 干预采用创新的混合1临床有效性-实施设计来评估新的 以退伍军人为中心的30天和180天死亡率、非家庭出院、再住院和家庭- 时间到了。详细的形成性评估(FE)将评估影响采用的提供商和系统因素 暂停干预。此外，这项研究还得到了三个国家业务伙伴的支持：国家外科 NSO办公室(NSO)、老年医学和长期护理办公室以及姑息治疗和临终关怀计划。 具体目标：我们对这个项目的目标有三个：(1)测试暂停试验的有效性 干预与常规护理在改善30天和180天死亡率、非家庭出院、再住院和 接受手术评估的患者的家庭时间；(2)测试暂停干预的主持人 有效性(治疗效果异质性)，特别是专业、脆弱程度和风险状况；以及(3) 使用混合方法形成性评估来了解影响保真度、适应性和 实施暂停干预。我们假设暂停干预将导致 减少30天和180天的死亡率、再次住院、非家庭出院和增加所有人的回家时间 退伍军人(目标1)。对于某些专科的虚弱患者，对结果的影响程度将更大(目标2)。 同时举行的现场专家会议将突出今后执行工作的主要障碍/促进者(目标3)。 方法：PAUSE试验是一项务实的阶梯式楔形随机临床试验，旨在捕获 计划在3家大型三级医疗VAMC(帕洛阿尔托，休斯顿)进行择期手术的25,000名退伍军人队列 和纳什维尔)和7个专科组别：普通科、血管科、骨科、心胸外科、泌尿科、神经外科 以及其他(如塑料和耳鼻喉科)。干预措施将是对虚弱的筛查和转诊至“多学科” 暂停板“(外科、麻醉、老年病、姑息治疗、病例管理、康复和营养) 寻求建议。每一步都将是一个随机选择的专科小组，从常规护理过渡到 暂停干预。结果包括30天和180天的死亡率、非家庭出院、再次住院 回家的时间到了。将使用实施研究综合框架(CFIR)来指导FE 并对影响实施的因素进行分析。这项研究跨越了4年的干预前FE (Y1)、暂停干预(Y1-3)、干预后FE(Y3)和分析(Y4)。 下一步：暂停干预将导致为更广泛的 通过更大的供资机制或业务在其他地点传播和未来执行 支持。未来的步骤包括正式的预算影响分析和卫生保健利用前后的研究 暂停VA系统中的干预。

Background: Frailty is a syndrome of reduced physiologic reserve associated with higher postoperative mortality and adverse outcomes. Our preliminary work shows that institution-wide frailty screening and introducing a “pre-surgical pause” reduces 6-month mortality by threefold. However, a knowledge gap exists in the nature of the intervention and which stakeholders should be involved in the “pre-surgical pause”. Multidisciplinary care models for complex patients are highly effective in oncology, wound care and primary care. We propose a new intervention i.e. PAtient-centered mUltidiSciplinary care for vEterans undergoing surgery (PAUSE), where experts from diverse fields will contribute to surgical decision-making and optimization of outcomes for high-risk Veterans. Impact: Aging Veterans are a fast-growing population with significant need for high-quality surgical care. This study will build a structured multidisciplinary workflow to improve clinical and quality outcomes and provide high-value care per VA priorities for frail and high-risk Veterans that aligns with their goals and expectations. Innovation: This is the first study in the VA to implement a multidisciplinary care model for surgical care. The intervention employs an innovative hybrid 1 clinical effectiveness-implementation design to evaluate novel Veteran-centric outcomes of 30- and 180-day mortality, non-home discharge, rehospitalizations and home- time. A detailed formative evaluation (FE) will evaluate provider and system factors that impact uptake of the PAUSE intervention. Further, the study has support from three national operational partners: National Surgery Office (NSO), Office of Geriatrics and Extended Care, and Palliative Care and Hospice Program. Specific Aims: Our goals for this project are three-fold: (1) to test the effectiveness of the PAUSE trial intervention vs usual care in improving 30- and 180-day mortality, non-home discharge, rehospitalizations and home-time for patients undergoing surgical evaluation; (2) to test moderators of the PAUSE intervention effectiveness (treatment effect heterogeneity), especially specialty, frailty severity and risk status; and (3) to use a mixed-method formative evaluation to understand the factors that influence fidelity, adaptation, and implementation of the PAUSE intervention. We hypothesize that the PAUSE intervention will lead to a decrease in 30- and 180-day mortality, rehospitalizations, non-home discharge and increase home-time for all Veterans (Aim 1). The effect size for the outcomes will be greater for frail patients in certain specialties (Aim 2). The concurrent FE will highlight key barriers/facilitators for future implementation (Aim 3). Methodology: The PAUSE trial is a pragmatic, stepped wedge randomized clinical trial designed to capture a cohort of 25,000 Veterans scheduled for elective surgery at 3 large tertiary care VAMCs (Palo Alto, Houston and Nashville) and 7 specialty groups: general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery and others (e.g., plastics and ENT). The intervention will be frailty screening and referral to a “multidisciplinary PAUSE board” (surgery, anesthesia, geriatrics, palliative care, case management, rehabilitation and nutrition) for recommendations. Each ‘step’ will be a randomly chosen specialty group transitioning from usual care to the PAUSE intervention. Outcomes include 30- and 180-day mortality, non- home discharge, rehospitalizations and home-time. The Consolidated Framework for Implementation Research (CFIR) will be used to guide FE and analysis of factors that influence implementation. The study spans across 4 years for pre-intervention FE (Y1), PAUSE intervention (Y1-3), post-intervention FE (Y3) and analysis (Y4). Next Steps: The PAUSE intervention will result in development of an “Implementation Guide” for wider dissemination and future implementation at other sites through larger funding mechanisms or operational support. Future steps include formal budget impact analysis and study of health care utilization pre- and post- PAUSE intervention in the VA system.