Low Back Pain in Older Veterans: Preparing for Personalized Care

老年退伍军人的腰痛：为个性化护理做好准备

• 批准号: 8979456
• 负责人: DEBRA KAYE WEINER
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8979456
• 关键词: Address; Adrenal Cortex Hormones; Age; Aging; Agreement; Algorithms; American; Anxiety; Arthritis; Back; Belief; Caring; Clinical; Clinical Trials; Cognitive; Computerized Medical Record; Computers; Coping Skills; Data; Delphi Technique; Dementia; Disease; Educational process of instructing; Elderly; Eligibility Determination; Evaluation; Evidence based treatment; Exclusion Criteria; Fibromyalgia; Fright; Funding; Future; Geriatric Psychiatry; Geriatrics; Guidelines; Hip Osteoarthritis; Hip region structure; Image; Individual; Injection of therapeutic agent; Intervention; Interview; Letters; Literature; Low Back Pain; Magnetic Resonance Imaging; Medicine; Mental Depression; Mood Disorders; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Outcome Measure; Pain; Pain Clinics; Pain Measurement; Pain management; Participant; Pathology; Patient Care; Patients; Performance; Pharmacological Treatment; Pharmacology; Physical Examination; Physical Medicine; Pilot Projects; Prevalence; Primary Health Care; Principal Investigator; Procedures; Process; Protocols documentation; Provider; Psychology; Publishing; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recommendation; Recording of previous events; Records; Rheumatology; Sample Size; Schedule; Site; Societies; Spinal; Spondylarthritis; Structure; Telephone; Time; Titrations; Training; United States; Vertebral column; Veterans; arm; base; clinical efficacy; clinical practice; cost; design; disability; efficacy trial; evidence base; experience; health administration; high risk; improved; improved functioning; inclusion criteria; member; mild cognitive impairment; patient oriented; personalized care; primary outcome; public health relevance; tool; treatment as usual; treatment strategy; trial comparing; volunteer

DESCRIPTION (provided by applicant): The proposed pilot application is designed to prepare for a three-site randomized controlled clinical efficacy trial that compares, in older veterans with low back pain (LBP) outcomes associated with patient-centered comprehensive evaluation and treatment (PCCET) versus imaging-associated usual care (IAUC). Veterans who have just had lumbar Magnetic Resonance Imaging (MRI) will be targeted, as these patients often have not had a comprehensive history and physical examination to identify all contributors to their pain and disability and, therefore, are at high risk of experiencing suboptimal outcomes. Much of MRI-identified degenerative lumbar pathology is incidental in older adults and its identification often leads to invasive procedures that are ineffective and potentially dangerous. The pilot study has four aims. Aim 1: Evaluate the feasibility of the recruitment strategy for the future clinical effiacy trial by reviewing electronic medical records for inclusion and exclusion criteria (no red flags tht would require urgent LBP treatment, no previous spine surgery, no dementia). Records of veterans age 65-89 who are scheduled for a lumbar MRI will be reviewed at each of the three sites for one year. An estimated 314 participants will be needed for the future clinical efficacy trial (alpha .025, power 90%, effect 0.4) to detect meaningful between group differences in two primary outcome measures, the Roland Disability Questionnaire (RDQ) and the Short Physical Performance Battery (SPPB). Aim 2: Assess inter-rater agreement of the structured assessment that will be used to guide LBP care in the PCCET arm of the future clinical efficacy trial. The principal investigator has previously developed and published a LBP assessment protocol. She will teach two-three geriatrician providers at each of the three sites (Pittsburgh, Miami, Richmond) in performance of the protocol and 45 older veterans (15 at each site) will be evaluated using this tool. Veterans also will be evaluated for other key pain and disability generators - depression (with the CES-D), anxiety (with the GAD-7), mild cognitive impairment (with the computer-based assessment of mild cognitive impairment), fear avoidance beliefs (with the Fear Avoidance Beliefs Questionnaire), and pain coping skills (with the Cognitive Strategies Questionnaire). The PI and geriatrician providers will use these data combined with supplemental clinical interviews as indicated, to identify the contributors to LBP and disability from a structured checklist and inter-rater agreement will be evaluated. We will train providers to an inter-rater agreement of > .95. Aim 3: Estimate sample size for the future clinical efficacy tril by assessing the anticipated change in primary outcomes during IAUC and PCCET. For IAUC, another group of 45 veterans (15 at each site) will be invited to participate via primary care provider-signed letters. Volunteers will be evaluated on-site to confirm eligibility and collect th primary outcome measures for the clinical trial - the RDQ and the SPPB. Participants will be telephoned monthly to collect structured information on LBP interventions sought and received. For PCCET, 20 veterans treated in the PI's pain clinic will be followed in a manner similar to the IAUC participants. The RDQ and SPPB will be repeated in 6 months on all and 12 months on 75% of participants. Aim 4: Standardize the treatments that will be delivered in the PCCET arm of the future clinical efficacy trial. This will be accomplished by drawing from evidence-based literature and a 33-member interdisciplinary panel of experts (geriatric medicine, geriatric pharmacology, geriatric psychiatry, low back pain, pain medicine, primary care, psychology, rehabilitation medicine and rheumatology) using a Modified Delphi technique. After accomplishing the aims outlined, we will be well- prepared to design the clinical efficacy trial tht has the potential to improve function and quality of life for millions of older veterans. PUBLIC HEALTH RELEVANCE: Currently there are over 9 million United States veterans age 65 and older and low back pain (LBP) is one of the most common causes of disability in these individuals.1,17 When these patients are evaluated using advanced imaging (e.g., MRI) and treated as an aging spine rather than an older adult with spine pain, results are often suboptimal. Spinal arthritis is common in older adults with and without pain and conditions outside of the spine such as hip arthritis, depression, and fibromyalgia may be responsible for LBP and disability, but practitioners are often poorly educated about these conditions.4,5,48,49 Thus we are ill-equipped to implement the 1998 VHA National Pain Management Strategy for older veterans with LBP. This pilot study will inform a future randomized controlled trial to evaluate the benefits in veterans with LBP age 65-89 who have undergone lower back MRI of patient-centered comprehensive treatment as compared with usual care. We believe the patient-centered comprehensive approach could save substantial suffering for millions of older veterans.

描述（由申请人提供）： 拟议的试点应用旨在为三个位点随机对照临床疗效试验做准备，该试验比较了与患者以患者为中心的综合评估和治疗（PCCET）相对于与成像相关的常规护理（IAUC）相关的老年退伍军人（LBP）结果。刚刚具有腰部磁共振成像（MRI）的退伍军人将被瞄准，因为这些患者通常没有全面的病史和体格检查来识别所有导致其疼痛和残疾的贡献者，因此，体验下次最好的结果的高风险。在老年人中，大多数MRI识别的退化性腰部病理是偶然的，其鉴定通常是 导致无效且潜在危险的侵入性程序。试点研究有四个目标。目标1：通过审查包含和排除标准的电子医疗记录，评估未来临床艾菲西亚未来临床试验招聘策略的可行性（没有危险旗帜需要紧急LBP治疗，没有以前的脊柱手术，没有痴呆症）。计划在三个地点中的每个地点进行一年的审查65-89岁退伍军人的记录。未来的临床疗效试验（Alpha .025，功率90％，效果0.4）将需要314名参与者，以检测两种主要结果指标的群体差异之间有意义的有意义的，Roland残疾问卷（RDQ）和短体绩效电池（SPPB）。 AIM 2：评估结构化评估的评价者一致性，该评估将用于指导未来临床疗效试验的PCCET部门中的LBP护理。首席研究者先前已经开发并发布了LBP评估方案。她将在三个地点（匹兹堡，迈阿密，里士满）中的每个站点中的每个站点中教授两三个老年医生提供者，并将使用此工具评估45名老年退伍军人（每个地点15位）。还将评估退伍军人的其他关键疼痛和残疾发生器 - 抑郁症（带有CES-D），焦虑症（带有GAD-7），轻度认知障碍（基于计算机的轻度认知障碍评估），恐惧回避避免信念（害怕回避信念问卷）以及痛苦的应对技巧（以及认知策略）。 PI和老年医生提供者将使用这些数据以及所示的补充临床访谈，以确定LBP的贡献者和从结构化清单和律师间协议中的残疾贡献者。我们将培训提供商 评价者间协议> .95。 AIM 3：通过评估IAUC和PCCET期间主要结果的预期变化来估计未来临床疗效三角形的样本量。对于IAUC，将邀请另一组45名退伍军人（每个站点的15名退伍军人）通过初级保健提供者的信件参加。将在现场评估志愿者，以确认资格并收集临床试验的主要结果指标-RDQ和SPPB。参与者将每月打电话给参与者，以收集有关LBP干预措施的结构性信息。对于PCCET，将以与IAUC参与者相似的方式遵循在PI疼痛诊所接受治疗的20名退伍军人。 RDQ和SPPB将在75％的参与者中在6个月内和12个月内重复。 AIM 4：标准化将在未来临床功效试验的PCCET部门提供的治疗方法。这将是通过循证文献和由33名成员组成的专家跨学科小组（老年医学，老年药理学，老年精神病学，下腰痛，疼痛医学，心理学，心理学，康复医学和流变学）使用改良的Delphi技术来实现的。在完成了概述的目标之后，我们将准备好设计临床疗效试验的可能性，有可能改善数百万退伍军人的功能和生活质量。 公共卫生相关性： 目前，有超过900万美国退伍军人65岁及65岁及以后的腰痛（LBP）是这些人最常见的残疾原因之一。1,17当使用高级成像（例如MRI）评估这些患者时，并被视为衰老的脊柱，而不是脊柱疼痛，而不是患有脊柱疼痛的老年人，结果通常是次要的。脊柱关节炎在脊柱以外的老年人中很常见，例如髋关节炎，抑郁症和纤维肌痛可能导致LBP和残疾负责，但是从业者通常对这些状况受过良好教育。4,5,48,49因此，我们对1998年VHA National Pain National Pain Management Management vetherans veterans a lbp lbp的实施不足。这项试点研究将为未来的随机对照试验提供信息，以评估LBP年龄65-89岁的退伍军人的收益，他们接受了以患者为中心的综合治疗的下背部MRI，与通常的护理相比。我们认为，以患者为中心的综合方法可以节省数百万老年退伍军人的巨大痛苦。