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）： 拟议的试点应用程序旨在为一项三中心随机对照临床疗效试验做准备，该试验对患有腰痛 (LBP) 的老年退伍军人与以患者为中心的综合评估和治疗 (PCCET) 相关的结果与与影像相关的常规护理相关的结果进行比较（IAUC）。刚刚接受过腰椎磁共振成像 (MRI) 的退伍军人将成为目标，因为这些患者通常没有进行全面的病史和体检来确定导致其疼痛和残疾的所有因素，因此很有可能出现不理想的结果。大部分 MRI 发现的退行性腰椎病变在老年人中是偶然发生的，其识别通常是 导致无效且具有潜在危险的侵入性手术。该试点研究有四个目标。目标 1：通过审查电子病历的纳入和排除标准（没有需要紧急 LBP 治疗的危险信号、以前没有脊柱手术、没有痴呆）来评估未来临床疗效试验招募策略的可行性。计划进行腰椎 MRI 的 65 岁至 89 岁退伍军人的记录将在三个地点分别进行为期一年的审查。未来的临床疗效试验预计需要 314 名参与者（α 0.025，功效 90%，效果 0.4），以检测罗兰残疾问卷 (RDQ) 和简短体能表现测试这两项主要结果指标中组间有意义的差异（SPPB）。目标 2：评估结构化评估的评估者间一致性，该评估将用于指导未来临床疗效试验的 PCCET 组中的 LBP 护理。主要研究者此前已制定并发布了 LBP 评估方案。她将在三个地点（匹兹堡、迈阿密、里士满）的每一个地点教授两到三名老年医学提供者如何执行协议，并将使用该工具对 45 名老年退伍军人（每个地点 15 名）进行评估。退伍军人还将接受其他关键疼痛和残疾产生因素的评估 - 抑郁（使用 CES-D）、焦虑（使用 GAD-7）、轻度认知障碍（基于计算机的轻度认知障碍评估）、回避恐惧信念（使用恐惧避免信念问卷）和疼痛应对技巧（使用认知策略问卷）。 PI 和老年医学提供者将使用这些数据与所示的补充临床访谈相结合，从结构化检查表中确定导致 LBP 和残疾的因素，并评估评估者间的一致性。我们将培训供应商 评估者间的一致性 > .95。目标 3：通过评估 IAUC 和 PCCET 期间主要结局的预期变化来估计未来临床疗效的样本量。对于 IAUC，另一组 45 名退伍军人（每个地点 15 名）将通过初级保健提供者签署的信件被邀请参加。志愿者将在现场接受评估，以确认资格并收集临床试验的主要结果指标 - RDQ 和 SPPB。参与者将每月接到电话，收集有关寻求和收到的 LBP 干预措施的结构化信息。对于 PCCET，将以与 IAUC 参与者类似的方式对在 PI 疼痛诊所接受治疗的 20 名退伍军人进行跟踪。 RDQ 和 SPPB 将在 6 个月内对所有参与者重复进行，并在 12 个月内对 75% 的参与者重复进行。目标 4：标准化未来临床疗效试验的 PCCET 组中将提供的治疗。这将通过借鉴基于证据的文献和由 33 名成员组成的跨学科专家小组（老年医学、老年药理学、老年精神病学、腰痛、疼痛医学、初级保健、心理学、康复医学和风湿病学）使用改良的方法来完成德尔菲技术。实现概述的目标后，我们将做好充分准备，设计临床疗效试验，该试验有可能改善数百万老年退伍军人的功能和生活质量。 公共卫生相关性： 目前，美国有超过 900 万年龄在 65 岁及以上的退伍军人，腰痛 (LBP) 是这些人残疾的最常见原因之一。1,17 当使用先进成像（例如 MRI）和如果将其视为老化的脊柱而不是患有脊柱疼痛的老年人，结果往往不是最理想的。脊柱关节炎在有或没有疼痛的老年人中很常见，脊柱以外的疾病（如髋关节炎、抑郁症和纤维肌痛）可能是腰痛和残疾的原因，但从业者往往对这些疾病缺乏了解。4,5,48, 49 因此，我们没有能力为患有 LBP 的老年退伍军人实施 1998 年 VHA 国家疼痛管理战略。这项试点研究将为未来的随机对照试验提供信息，以评估 65-89 岁患有 LBP 的退伍军人接受以患者为中心的综合治疗与常规护理相比接受下背部 MRI 的益处。我们相信，以患者为中心的综合方法可以为数百万老年退伍军人减轻巨大的痛苦。