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对年长的退伍军人（65岁以上）的护理 背痛（CLBP，即至少一半的腰痛至少6个月）。当前的CLBP护理是 受到过度注重脊柱或开处方的限制。以脊柱为中心的护理经常针对目标 腰椎的退化性疾病（例如，退化性椎间盘/方面疾病，椎间盘隆起）几乎是 在老年人中无处不在，即使是那些无痛的人。通用CLBP护理通常由物理组成 治疗和口服镇痛药，许多镇痛药在老年人中可能具有严重的副作用 胃肠道出血和髋部骨折。以脊柱为中心的护理和通用护理通常会导致次优 疼痛和功能的改善。通过先前的VA资金，我们为 以患者为中心的护理CLBP，衰老后诊所（ABC）的老年退伍军人的方法，其中脊柱 是脆弱性的来源，但不是唯一的治疗靶标。 ABC接近CLBP作为老年综合症， 也就是说，表达多个贡献者的最终共同途径，而不是脊柱疾病。在我们的 先前的工作：1）使用改良的Delphi与42位疼痛专家和初级保健提供者合作 开发12种基于证据的，老年人的评估和治疗算法的方法 导致CLBP老年人疼痛和残疾的疾病，即髋骨关节炎，纤维肌痛， 适应不良的应对，腿部长度差异，焦虑，抑郁，肌筋膜疼痛，失眠，s骨关节 综合征，外侧髋部/大腿疼痛（例如，较大的动骨疼痛综合征），腰椎狭窄，痴呆症。 2）在老年退伍军人中确立了这些贡献者的共同性质。 3）验证可行性和 ABC护理对VA提供者和退伍军人的可接受性。 4）使用迭代可用性测试来开发 交互式工具，退回您的后背，有效地筛选了非肌肉骨骼条件（即， 适应不良的应对，抑郁，焦虑，失眠，纤维肌痛），并教育患者有关现实的 治疗期望和CLBP是一种生物心理社会综合征，而不是脊柱疾病。这 拟议的随机对照临床试验旨在测试ABC的效率与通常 关心。三百三十名退伍军人65-89岁（来自3个地点的每一个 - VA Pittsburgh Healthcare System，110 达拉斯·弗吉尼亚州，亨特·霍尔姆斯·麦奎尔（Richmond）VA），带有CLBP，没有危险信号 潜在的疾病将随机分配给ABC或UC 3个月，然后在12个月后进行12个月 随机化。 ABC将是由顾问组成的虚拟诊所（例如，老年医学，止痛药， 风湿病学）接受了与我们的算法合作的培训，这些算法会将患者转介给其他提供者（例如，物理 治疗，行为健康，脊椎治疗）。通常的护理不会受到限制。基线度量 将在现场进行评估，包括：NIH研究小组推荐的最小数据集 CLBP的标准； OSWESTRY残疾指数（ODI；主要结果）；认知功能（QMCI）; PROMIS-29 其中包括疼痛严重程度，与疼痛相关的活动干扰，身体机能，睡眠障碍，抑郁症 症状，腿部症状； Promis-Global Health（GH）量表的生活质量，对阿片类药物的担忧 随着规定的阿片类药物的困难量表，获得速度，平衡信心与跌倒功效量表 - 国际短期；和上个月的医疗保健利用 - 例如，止痛药，紧急情况 房间探访，住院。三个，6，9和12个月的结果（ODI，PROMIS 29和GH，平衡 信心，医疗保健利用）将通过电话掩盖小组分配的工作人员进行评估。 我们假设将随机分配给ABC护理的退伍军人将有明显的改善 与UC中的疼痛相关的残疾（ODI）。拟议的临床试验不仅有可能改善 与疼痛有关的残疾，但也要降低发病率，提高生活质量并限制医疗保健利用。