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

为接受手术的退伍军人提供以患者为中心的多学科护理（PAUSE）：一项混合 1 临床有效性实施干预试验

• 批准号: 10404947
• 负责人: Shipra Arya
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10404947
• 关键词: Adoption; Affect; Aging; Anesthesia procedures; Blood Vessels; Caring; Case Management; Cessation of life; Chest; Clinic; Clinical; Clinical Trials Design; Clinical effectiveness; Collection; Complex; Consensus; Consolidated Framework for Implementation Research; Data; Data Analyses; Decision Making; Development; Dissemination and Implementation; Effectiveness; Effectiveness of Interventions; Evaluation; Factor Analysis; Funding Mechanisms; Future; Geriatrics; Goals; Healthcare; Heterogeneity; Home; Hospice Care; Hospice Programs; Hospitalization; Hybrids; Institution; Institutionalization; Intervention; Intervention Trial; Interview; Knowledge; Lead; Life; Long-Term Care; Measures; Methodology; Methods; Minor Surgical Procedures; Modeling; Morbidity - disease rate; Nature; Needs Assessment; Office Surgery; Oncology; Operative Surgical Procedures; Orthopedics; Outcome; Palliative Care; Patient-Centered Care; Patient-Focused Outcomes; Patients; Physiological; Plastics; Population; Postoperative Period; Primary Health Care; Process; Provider; Quality of life; Randomized Clinical Trials; Recommendation; Rehabilitation therapy; Research Design; Research Methodology; Research Personnel; Resources; Risk; Schedule; Severities; Site; Site Visit; Specialist; Structure; Surgical Models; Syndrome; System; Testing; Time; Urology; Use Effectiveness; Veterans; Work; adverse outcome; aged; budget impact; clinical care; cohort; contextual factors; cost; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; effectiveness testing; expectation; experience; formative assessment; frailty; future implementation; health care service utilization; high risk; hospital readmission; implementation framework; implementation intervention; improved; improved outcome; indexing; innovation; medical specialties; mortality; multidisciplinary; neurosurgery; novel; nutrition; patient oriented; perioperative mortality; post intervention; programs; screening; surgery outcome; tertiary care; treatment as usual; treatment effect; uptake; wound; wound care

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.

背景：虚弱是一种生理储备减少的综合征，与较高的术后 我们的初步工作表明，机构范围内的衰弱筛查和不良后果。 引入“术前暂停”可将 6 个月死亡率降低三倍。然而，这方面存在知识差距。 干预的性质以及哪些利益相关者应参与“术前暂停”。 针对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 我们提出了一种新的干预措施，即为正在接受治疗的退伍军人提供以患者为中心的多学科护理。 手术（暂停），来自不同领域的专家将参与手术决策和 优化高风险退伍军人的结果。 影响：老年退伍军人是一个快速增长的群体，对高质量的手术护理有很大的需求。 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，为体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第一项针对外科护理实施多学科护理模式的研究。 干预采用创新的混合 1 临床有效性实施设计来评估新颖的 以退伍军人为中心的 30 天和 180 天死亡率、非居家出院、再住院和居家治疗结果 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。 此外，该研究得到了三个国家运营合作伙伴的支持：国家外科手术。 办公室 (NSO)、老年病学和延伸护理办公室以及姑息治疗和临终关怀计划。 具体目标：我们这个项目的目标有三个：（1）测试 PAUSE 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 PAUSE 干预的调节器 有效性（治疗效果异质性），特别是专业、虚弱严重程度和风险状态；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 我们勇敢地说，暂停干预将导致 减少 30 天和 180 天死亡率、再住院率、非家庭出院率并增加所有人的居家时间 退伍军人（目标 1）。对于某些专业的体弱患者，结果的影响更大（目标 2）。 同期的 FE 将强调未来实施的主要障碍/促进因素（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 由 25,000 名退伍军人组成的队列计划在 3 个大型三级护理 VAMC（帕洛阿尔托、休斯顿）接受择期手术 以及 7 个专科组：普通科、血管科、骨科、心胸科、泌尿科、神经外科 和其他（例如，塑料和耳鼻喉科）干预措施将是衰弱筛查和转诊至“多学科”。 暂停委员会”（手术、麻醉、老年病学、姑息治疗、病例管理、康复和营养） 每个“步骤”都是随机选择的专业组，从常规护理过渡到护理。 PAUSE 干预的结果包括 30 天和 180 天死亡率、非家庭出院、再住院。 实施研究综合框架（CFIR）将用于指导 FE。 干预前 FE 的研究跨度为 4 年。 (Y1)、PAUSE 干预 (Y1-3)、干预后 FE (Y3) 和分析 (Y4)。 后续步骤：暂停干预将导致为更广泛的范围制定“实施指南” 通过更大的融资机制或业务机制在其他地点进行传播和未来实施 未来的步骤包括正式的预算影响分析以及事前和事后医疗保健利用情况的研究。 暂停对 VA 系统的干预。