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: 10187856
• 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 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10187856
• 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; 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; 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， 死亡率和不良后果。我们的初步工作表明，机构范围内的弱点筛选和 引入“术前暂停”可将6个月的死亡率降低三倍。然而，知识差距存在于 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。 在乎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， 手术（暂停），来自不同领域的专家将有助于手术决策， 优化高风险退伍军人的结果。 影响：老龄化退伍军人是一个快速增长的人口，对高质量的外科护理有着重大的需求。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VA优先考虑的体弱和高风险退伍军人的高价值护理，符合他们的目标和期望。 创新：这是退伍军人管理局第一项在手术护理中实施多学科护理模式的研究。的 干预采用创新的混合1临床有效性实施设计，以评估新的 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- 时间详细的形成性评估（FE）将评估影响 暂停干预。此外，这项研究得到了三个国家业务伙伴的支持： 办公室（NSO），老年病和延伸护理办公室，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方面：（1）测试PAUSE试验的有效性 干预与常规治疗相比，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在家时间;（2）测试PAUSE干预的调节器 有效性（治疗效果异质性），尤其是专科、虚弱严重程度和风险状态;以及（3） 使用混合方法的形成性评价，以了解影响保真度，适应性和 实施暂停干预。我们假设PAUSE干预将导致 减少30天和180天死亡率、再住院、非在家出院，并增加所有人的在家时间 退伍军人（目标1）。对于某些专科的虚弱患者，结局的效应量将更大（目标2）。 同时进行的FE将强调未来实施的关键障碍/促进因素（目标3）。 方法：PAUSE试验是一项务实的阶梯式随机临床试验，旨在获取 25，000名退伍军人的队列计划在3个大型三级护理VAMC（Palo Alto，Houston）进行择期手术 和纳什维尔）和7个专科组：普通科、血管科、骨科、心胸科、泌尿科、神经外科 以及其它（例如，塑料和ENT）。干预措施将是虚弱筛查和转诊到“多学科” 暂停板”（手术、麻醉、老年病、姑息治疗、病例管理、康复和营养） 以获得建议。每个“步骤”将是一个随机选择的专业组，从常规护理过渡到 暂停干预。结果包括30天和180天死亡率、非家庭出院、再住院 回家的时间实施研究综合框架（CFIR）将用于指导FE 分析影响执行的因素。该研究的干预前FE时间跨度为4年 (Y1)、暂停干预（Y1-3）、干预后FE（Y3）和分析（Y 4）。 下一步：暂停干预措施将导致制定一个“实施指南”， 通过更大的供资机制或业务机制， 支持.未来的步骤包括正式的预算影响分析和研究前和后的保健利用情况， 暂停VA系统中的干预。