Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery

试点康复服务旨在改善体弱的退伍军人在接受重大腹部手术后的结果

• 批准号: 9291841
• 负责人: Daniel E Hall
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-01-01 至 2018-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9291841
• 关键词: Abdomen; Abdomen; Age; Age; Aged, 80 and over; Aged, 80 and over; Balance training; Balance training; Cardiac; Cardiac; Cardiac rehabilitation; Cardiac rehabilitation; Caring; Caring; Chest; Chest; Clinic; Clinic; Clinical; Clinical; Comorbidity; Comorbidity; Consultations; Consultations; Data; Data; Development; Development; Disease; Disease; Elderly; Elderly; Enrollment; Enrollment; Environmental Risk Factor; Environmental Risk Factor; Geriatrics; Geriatrics; Goals; Goals; Habilitation; Habilitation; Healthcare Systems; Healthcare Systems; Home environment; Home environment; Independent Living; Independent Living; Infrastructure; Institutionalization; Institutionalization; Intervention; Intervention; Investigation; Investigation; Length of Stay; Length of Stay; Letters; Life; Life; Long-Term Care; Long-Term Care; Measures; Measures; Medical; Medical; Methods; Methods; Morbidity - disease rate; Morbidity - disease rate; Muscle; Muscle; Muscular Atrophy; Muscular Atrophy; Nutrition Assessment; Nutrition Assessment; Nutritional; Nutritional; Operative Surgical Procedures; Operative Surgical Procedures; Orthopedics; Orthopedics; Outcome; Outcome; Participant; Participant; Patient risk; Patient-Focused Outcomes; Patient-Focused Outcomes; Patients; Patients; Perioperative; Physical Performance; Physical Performance; Physical activity; Physical activity; Physiological; Physiological; Pilot Projects; Pilot Projects; Population; Population; Postoperative Period; Postoperative Period; Prealbumin; Prealbumin; Procedures; Procedures; Randomized; Randomized; Randomized Controlled Trials; Randomized Controlled Trials; Recovery; Recovery; Recruitment Activity; Regimen; Regimen; Research; Research; Research Infrastructure; Research Personnel; Research Personnel; Risk; Risk; Schedule; Schedule; Services; Services; Standardization; Standardization; Stress; Stress; Supplementation; Supplementation; Surgeon; Surgeon; Syndrome; Syndrome; System; System; Testing; Testing; Time; Time; Training; Training; Urologic Surgical Procedures; Urologic Surgical Procedures; Veterans; Veterans; Work; Work; base; base; cohort; cohort; cost; cost; design; design; exercise training; exercise training; exhaustion; exhaustion; experience; experience; frailty; frailty; health related quality of life; health related quality of life; improved; improved; improved outcome; improved outcome; innovation; innovation; interest; interest; mortality; mortality; mortality risk; novel; novel; nutrition; nutrition; nutritional supplementation; nutritional supplementation; pedometer; perioperative mortality; post-operative rehabilitation; post-operative rehabilitation; pressure; pressure; pulmonary function; pulmonary function; recruit; rehabilitation strategy; rehabilitation strategy; statistics; statistics; strength training; strength training; success; success; surgery outcome; surgical risk

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgeons operate safely on even the oldest old, if the elder is also frail, the stress of surgery can result in significant mortality, morbidity, and institutionalization. Frailty is a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age, and is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older and more frail, it is critically important to identify effective strategies for improving the surgical outcomes of these patients. “Prehabilitation” has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength, improving nutrition, and optimizing home supports. Based on this success, there is growing interest in deploying similar interventions before surgery in what some call “prehabilitation.” By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of both surgery and recovery. Frail patients will likely benefit disproportionately from prehabilitation because they have the most diminished capacity to adapt to the stress of surgery. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations. Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation intervention aimed at improving postoperative outcomes for frail Veterans undergoing major abdominal surgery. Specific aims are to: (1) Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention; (2) Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline and 2-week intervals to estimate changes over time and explore the optimal duration of prehabilitation (2 vs. 4 vs. 6 weeks); and (3) Estimate overall and treatment-specific summary statistics for postoperative outcomes in terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change in level of independent living. Methods: This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major abdominal surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System. We will randomize participants 1:1 to receive either: (1) standard preoperative optimization by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. Assessments will include standard postoperative outcomes as well as the Short Physical Performance Battery to measure physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each year.

背景：脆弱的退伍军人的手术结局不良风险增加。虽然外科医生运作 即使是最古老的老年人，如果年龄较大，手术的压力也会导致重大死亡率， 发病率和制度化。脆弱是一种以肌肉萎缩为特征的临床综合征，强度降低， 减少体育锻炼和疲惫。它独立于任何特定疾病，但随着年龄的增长而增加， 并且是增加周期性死亡率，发病率，住院时间和成本的强大预测指标 仅基于年龄或合并症的预测。随着退伍军人和美国人口的增长和脆弱的年龄， 对于确定改善这些患者的手术结局的有效策略至关重要。 “居民”有可能改善脆弱的手术结果。先前的研究 证明手术后部署的跨学科康复策略可以增强康复和 通过建立力量，改善营养和优化家庭支持来改善结果。基于此 成功，对在手术前部署类似的干预措施的兴趣越来越兴趣 “预居住。”通过修改身体和环境风险，预植物旨在增加患者 补偿手术和恢复应力的能力。脆弱的患者可能会受益 不成比例地来自预居住，因为它们的适应压力的能力最低 手术。但是，尚未在退伍军人或专门脆弱的人群中进行预居住。 目的：我们将研究针对的新颖，多方面的预先启动干预的可行性 改善接受大腹部手术的体弱退伍军人的术后结局。具体目的是： （1）估计招募，随机化，保留率和遵守预居住干预的速度； （2）测量（a）身体表现，（b）肺功能和（c）基线和2周的营养 间隔以估计随时间变化并探索最佳居民持续时间（2 vs. 4 vs. 6 周）；和 （3）根据30和30和 90天（a）死亡率，（b）重大并发症，（c）住院时间，（d）与健康相关的生活质量，（e） 手术护理的质量和（f）独立生活水平的变化。 方法：这项随机试验研究将招募多达50名退伍军人的结果队列 使用标准化的脆弱评估，并计划进行一般腹部手术或 VA匹兹堡医疗保健系统的泌尿外科手术服务。我们将将参与者随机1：1归于 要么接受：（1）跨学科医学术前评估的标准术前优化 咨询与治疗诊所（影响），或（2）预居住 +标准影响优化。 6周 长期的居留干预将包括（1）力量和平衡训练； （2）吸气肌肉训练； （3）营养教练和补充。评估将包括标准术后结果 以及衡量身体表现的短体性能电池，最大的灵感 测量肺功能的压力，以及prealbumin和7点主观全局评估 测量营养。结果将在手术后30或90天评估结果。遵守 居民治疗方案将通过患者记录和计数器进行评估。分析将告知 开发较大的随机对照试验，以测试预先居住干预措施。发现将是 与每年有42,000名脆弱的退伍军人相关。