Optimizing Outcomes for Older Veterans with Chronic Low back Pain Syndrome: Aging Back Clinics

优化患有慢性腰痛综合症的老年退伍军人的治疗结果：老龄化背部诊所

• 批准号: 10259672
• 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: 2018
• 资助国家: 美国
• 起止时间: 2018-10-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259672
• 关键词: Address; Advisory Committees; Age; Aging; Algorithms; Analgesics; Anxiety; Arthritis; Back; Back Pain; Caring; Chronic low back pain; Clinic; Clinical Trials; Data Set; Degenerative Disorder; Delirium; Dementia; Disease; Elderly; Emergency department visit; Equilibrium; Evaluation; Evidence based treatment; Expert Opinion; Exposure to; Fibromyalgia; Foundations; Funding; Gait speed; Gastrointestinal Hemorrhage; Geriatrics; Guidelines; Health Personnel; Healthcare; Healthcare Systems; Heterogeneity; Hip Fractures; Hip Osteoarthritis; Hip region structure; Hospitalization; Individual; International; Lateral; Leg; Length; Life; Link; Low Back Pain; Masks; Measures; Medicine; Mental Depression; Modeling; Morbidity - disease rate; Myofascial Pain Syndromes; Nature; Obesity; Opioid; Oral; Outcome; Pain; Pain-Free; Participant; Pathway interactions; Patient Care; Patient-Centered Care; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Physical Function; Physical therapy; Procedures; Protocols documentation; Provider; Publishing; Quality of life; Randomized; Randomized Controlled Clinical Trials; Research; Resources; Rheumatology; Sacroiliac joint structure; Savings; Severities; Site; Sleep disturbances; Sleeplessness; Source; Spinal Injections; Spinal Stenosis; Spine surgery; Subgroup; Symptoms; Syndrome; Telephone; Testing; Thigh structure; Training; Treatment Efficacy; Treatment outcome; United States National Institutes of Health; Vertebral column; Veterans; Work; acceptability and feasibility; anxiety symptoms; base; behavioral health; biopsychosocial; care providers; chiropracty; cognitive function; comparative efficacy; coping; cost; depressive symptoms; design; disability; efficacy testing; evidence base; expectation; experience; falls; global health; health care service utilization; human old age (65+); improved; improved outcome; indexing; interactive tool; mild cognitive impairment; pain reduction; patient oriented; prescription opioid; primary endpoint; primary outcome; randomized trial; recruit; rehabilitation research; research and development; secondary endpoint; secondary outcome; side effect; treatment as usual; usability; virtual

The purpose of the proposed clinical trial is to improve the care of older Veterans (age 65+) with chronic low back pain (CLBP, i.e., low back pain for at least 6 months on at least half the days). Current CLBP care is limited by being either overly spine-focused or generically prescribed. Spine-focused care often targets degenerative disease of the lumbar spine (e.g., degenerative disc/facet disease, disc bulge) that is nearly ubiquitous in older adults, even those who are pain-free. Generic CLBP care typically consists of physical therapy and oral analgesics, and many analgesics have potentially serious side effects in older adults such as gastrointestinal bleeding and hip fracture. Both spine-focused care and generic care often result in suboptimal improvement in pain and function. Through prior VA funding, we have laid the essential foundation for a patient-centered approach to care for older Veterans with CLBP, Aging Back Clinics (ABCs), in which the spine is a source of vulnerability but not the sole treatment target. ABCs approach CLBP as a geriatric syndrome, that is, a final common pathway for the expression of multiple contributors, not a disease of the spine. In our prior work we have: 1) Collaborated with 42 pain experts and primary care providers using a modified Delphi approach to develop 12 evidence-based, older adult-tailored evaluation and treatment algorithms for important conditions that contribute to pain and disability in older adults with CLBP, i.e., hip osteoarthritis, fibromyalgia, maladaptive coping, leg length discrepancy, anxiety, depression, myofascial pain, insomnia, sacroiliac joint syndrome, lateral hip/thigh pain (e.g., greater trochanteric pain syndrome), lumbar spinal stenosis, dementia. 2) Established the commonplace nature of these contributors in older Veterans. 3) Verified the feasibility and acceptability of ABC care to VA providers and Veterans. 4) Used iterative usability testing to develop an interactive tool, Take Back Your Back, that efficiently screens for non-musculoskeletal conditions (i.e., maladaptive coping, depression, anxiety, insomnia, fibromyalgia), and educates patients about realistic treatment expectations and CLBP as a biopsychosocial syndrome rather than a disease of the spine. The proposed randomized controlled clinical trial is designed to test the efficacy of ABCs as compared with Usual Care. Three hundred thirty Veterans age 65-89 (110 from each of 3 sites – VA Pittsburgh Healthcare System, Dallas VA, Hunter Holmes McGuire [Richmond] VA) with CLBP and no red flags indicative of serious underlying illness will be randomized to ABCs or UC for 3 months and followed for 12 months after randomization. The ABCs will be virtual clinics staffed by consultants (e.g., geriatrics, pain medicine, rheumatology) trained in working with our algorithms who will refer patients to other providers (e.g., physical therapy, Behavioral Health, chiropractic) as needed. Usual care will not be constrained. Baseline measures will be assessed on site and include: the Minimal Data Set recommended by the NIH Task Force on research standards for CLBP; Oswestry Disability Index (ODI; main outcome); cognitive function (QMCI); PROMIS-29 that includes pain severity, pain-related activity interference, physical function, sleep disturbance, depressive symptoms, leg symptoms; quality of life with the PROMIS-Global Health (GH) scale, concerns about opioids with the Prescribed Opioids Difficulties Scale, gait speed, balance confidence with the Falls Efficacy Scale- International short form; and healthcare utilization over the prior month – e.g., pain medications, emergency room visits, hospitalizations. Three, 6-, 9-, and 12-months outcomes (ODI, PROMIS 29 and GH, balance confidence, healthcare utilization) will be assessed over the telephone by staff masked to group assignment. We hypothesize that Veterans randomized to ABC care will experience significantly greater improvement in pain-related disability (ODI) than those in UC. The proposed clinical trial has the potential not only to improve pain-related disability, but also to reduce morbidity, increase quality of life and limit healthcare utilization.

拟议的临床试验的目的是改善患有慢性低氧血症的老年退伍军人(65岁以上)的护理 背部疼痛(CLBP，即至少有一半天持续至少6个月的腰痛)。目前的CLBP护理是 受限于过于专注于脊椎或者开出了一般性的处方。以脊柱为重点的护理通常是针对 腰椎退行性疾病(如退行性腰椎/小关节病、腰椎间盘突出症) 在老年人中普遍存在，甚至在那些没有疼痛的人中也是如此。一般的CLBP护理通常包括物理 治疗和口服止痛药，以及许多止痛药对老年人有潜在的严重副作用，如 胃肠道出血和髋部骨折。以脊柱为重点的护理和普通护理通常都会导致不理想的结果 疼痛和功能的改善。通过之前的退伍军人管理局资金，我们已经为 以患者为中心的方法护理患有CLBP的老年退伍军人，老年背部诊所(ABC)，其中脊柱 是脆弱性的来源，但不是唯一的治疗目标。ABC将CLBP视为一种老年综合征， 也就是说，多个贡献者表达的最终共同途径，而不是脊柱疾病。在我们的 我们之前的工作：1)使用改进的Delphi与42名疼痛专家和初级保健提供者合作 开发12种基于证据的、针对老年人的重要疾病评估和治疗算法的方法 导致老年人CLBP疼痛和残疾的疾病，如髋关节骨关节炎、纤维肌痛、 适应不良、腿长不等、焦虑、抑郁、肌筋膜痛、失眠、骶骨关节 腰椎管狭窄症、外侧髋部/大腿疼痛(例如，大粗隆疼痛综合征)、痴呆症。 2)确定了这些贡献者在老年退伍军人中的平凡性质。3)验证了方案的可行性， 退伍军人和退伍军人对ABC护理的接受度。4)使用迭代可用性测试来开发一个 交互式工具，Back Your Back，它有效地筛选非肌肉骨骼疾病(即， 适应不良应对、抑郁、焦虑、失眠、纤维肌痛)，并教育患者现实 治疗预期和CLBP是一种生物心理社会综合征，而不是一种脊柱疾病。这个 拟议的随机对照临床试验旨在测试ABC与通常情况下的疗效 关心。330名年龄在65-89岁之间的退伍军人(来自3个地点-VA匹兹堡医疗系统， 达拉斯，弗吉尼亚州亨特·霍姆斯·麦奎尔[里士满]，患有CLBP，没有危险信号表明严重 基础疾病将被随机分配到ABC或UC，为期3个月，并在之后随访12个月 随机化。ABC将是配备顾问的虚拟诊所(例如，老年病学，止痛药， 风湿病)接受过使用我们的算法的培训，他们会将患者转介给其他提供者(例如，体检 治疗、行为健康、脊椎疗法)。通常的护理不会受到限制。基线衡量标准 将在现场进行评估，包括：美国国立卫生研究院研究特别工作组推荐的最小数据集 CLBP标准；嗅觉障碍指数(ODI；主要结果)；认知功能(QMCI)；PROMIS-29 包括疼痛严重程度、疼痛相关活动干扰、身体功能、睡眠障碍、抑郁 症状，腿部症状；PROMIS-全球健康(GH)量表的生活质量，对阿片类药物的担忧 有了处方的阿片类药物难度量表，步态速度，与福尔斯疗效量表的平衡信心- 国际缩写；以及前一个月的医疗保健利用情况--例如止痛药、紧急情况 探视房间，住院治疗。3个月、6个月、9个月和12个月的结果(ODI，PROMIS 29和GH，BALANCE 信心、医疗保健利用率)将由戴着面具进行小组分配的工作人员通过电话进行评估。 我们假设，随机参加ABC护理的退伍军人在 疼痛相关功能障碍(ODI)高于UC。拟议的临床试验不仅有可能改善 这不仅是为了减少与疼痛相关的残疾，也是为了减少发病率、提高生活质量和限制医疗保健的使用。