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: 8390934
• 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/8390934
• 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地点的随机对照临床疗效试验做准备，该试验比较了以患者为中心的综合评价和治疗（PCCET）与成像相关常规护理（IAUC）相关的老年退伍军人腰痛（LBP）结局。刚刚进行腰椎磁共振成像（MRI）的退伍军人将成为目标，因为这些患者通常没有全面的病史和体格检查来确定其疼痛和残疾的所有因素，因此，经历次优结局的风险很高。许多MRI确定的退行性腰椎病变在老年人中是偶然的， 导致侵入性手术无效且具有潜在危险。试点研究有四个目标。目标1：通过审查电子病历的入选和排除标准（无需要紧急LBP治疗的危险信号、既往无脊柱手术、无痴呆），评价未来临床有效性试验招募策略的可行性。年龄在65-89岁的退伍军人的记录谁是腰椎MRI计划将审查在三个网站的每一个一年。估计未来的临床疗效试验（α 0.025，把握度90%，效应0.4）将需要314名受试者，以检测两个主要结局指标（罗兰残疾问卷（RDQ）和短期体能测试（SPPB））的组间差异。目标二：评估评估者之间对结构化评估的一致性，该评估将用于指导未来临床疗效试验PCCET组的LBP护理。主要研究者之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）的每一个地点教授两到三名老年医学医生，以执行该协议，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。退伍军人还将评估其他关键的疼痛和残疾发生器-抑郁症（CES-D），焦虑症（GAD-7），轻度认知障碍（基于计算机的轻度认知障碍评估），恐惧回避信念（恐惧回避信念问卷）和疼痛应对技能（认知策略问卷）。PI和老年医学提供者将使用这些数据结合所示的补充临床访谈，从结构化检查表中识别LBP和残疾的贡献者，并评估评估者间的一致性。我们将培训供应商， 评分员间一致性> .95。目的3：通过评估IAUC和PCCET期间主要结局的预期变化，估计未来临床疗效试验的样本量。对于IAUC，另一组45名退伍军人（每个站点15名）将被邀请通过初级保健提供者签名的信件参加。将对志愿者进行现场评估，以确认合格性并收集临床试验的主要结局指标-RDQ和SPPB。参与者将每月通过电话收集有关LBP干预措施的结构化信息。对于PCCET，将以类似于IAUC参与者的方式对在PI疼痛诊所接受治疗的20名退伍军人进行随访。所有受试者将在6个月内重复RDQ和SPPB，75%的受试者将在12个月内重复。目标4：标准化将在未来临床疗效试验的PCCET组中提供的治疗。这将通过借鉴循证文献和一个由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），使用改良德尔菲技术来完成。在完成所概述的目标后，我们将做好充分的准备，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。 公共卫生关系： 目前，美国有超过900万65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当使用先进的成像（例如，MRI），并作为一个老化的脊柱，而不是一个老年人与脊柱疼痛治疗，结果往往是次优。脊柱关节炎在伴有或不伴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，可能是导致腰痛和残疾的原因，但从业人员对这些疾病的认识往往很差。4，5，48，49因此，我们无法为患有腰痛的老年退伍军人实施1998年VHA国家疼痛管理策略。这项初步研究将为未来的随机对照试验提供信息，以评估65-89岁的LBP退伍军人接受以患者为中心的综合治疗的下背部MRI与常规治疗相比的益处。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节省大量的痛苦。