MOTIVATE to Improve Outcomes for Older Veterans with Musculoskeletal Pain and Depression

激励改善患有肌肉骨骼疼痛和抑郁的老年退伍军人的治疗结果

• 批准号: 10424860
• 负责人: UNA E. MAKRIS
• 金额: --
• 依托单位: VA NORTH TEXAS HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10424860
• 关键词: Address; Aging; Area; Arthritis; Behavior Therapy; Behavioral; Blinded; Brief Pain Inventory; Caring; Clinical; Clinical effectiveness; Complex; Cost Analysis; Data; Degenerative polyarthritis; Development; Direct Expenditure; Dissemination and Implementation; Effectiveness; Elderly; Enrollment; Evaluation; Feedback; Future; Goals; Guidelines; Health; Health Services Accessibility; Healthcare Systems; Hybrids; Improve Access; Indirect Expenditures; Intervention; Interview; Measurement; Mental Depression; Mental Health; Mental Health Services; Methodology; Modeling; Motivation; Movement; Musculoskeletal; Musculoskeletal Pain; Older Population; Operative Surgical Procedures; Outcome; Pain; Pain intensity; Pain interference; Pain management; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacology; Physical activity; Polypharmacy; Population; Primary Health Care; Promoting Action on Research Implementation in Health Services framework; Provider; Quality of life; Randomized; Randomized Controlled Trials; Refractory Disease; Reporting; Research; Research Priority; Resources; Safety; Self Efficacy; Services; Severities; Site; Sleep; Societies; Structure; Target Populations; Telephone; Testing; Treatment outcome; Veterans; Waiting Lists; aging population; arm; base; behavioral outcome; budget impact; chronic back pain; chronic musculoskeletal pain; comorbidity; contextual factors; cost; cost estimate; depressive symptoms; disability; economic cost; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; effectiveness-implementation RCT; evidence base; feasibility testing; frailty; human old age (65+); implementation cost; implementation facilitators; implementation framework; implementation process; impression; improved; improved outcome; innovation; intervention delivery; medical specialties; military veteran; motivational enhancement therapy; multiple chronic conditions; novel; pain behavior; pain catastrophizing; pain symptom; pilot trial; preference; primary endpoint; primary outcome; recruit; remote delivery; resilience; response; secondary outcome; symposium; telecoaching; trial design; uptake; virtual delivery; virtual healthcare

Background: Musculoskeletal (MSK) pain is the leading cause of disability and reduced quality of life among older adults. We also know that depressive symptoms frequently co-exist with MSK pain and complicate management. Despite rising costs attributed to MSK pain and depressive symptoms, few behavioral interventions have been developed to address these comorbid conditions in this vulnerable aging population. Significance: The PI, during her VA HSR&D CDA2, developed and tested the feasibility of a novel behavioral intervention targeting older Veterans with chronic back pain and depressive symptoms. MOTIVATE (Moving to Improve Pain and Depression in Older Veterans) incorporates evidence-based components of motivational interviewing (MI), values elicitation, goal setting and patient activation to motivate older Veterans to become more physically active, thereby improving pain interference, function, and depressive symptoms. MOTIVATE is delivered by a health coach via telephone or video during eight sessions over 12-weeks. Preliminary findings from the PI’s ongoing pilot trial of MOTIVATE show it is feasible, improves step counts, pain interference, and depressive symptoms. In response to VA HSR&D research priority areas, this application focuses on improving access to care, augmenting resources for primary care practices – specifically in the areas of pain management and aging, and leveraging virtual care to deliver behavioral interventions to vulnerable Veterans. Innovation/Impact: This research is innovative because we 1) target both MSK pain and depressive symptoms and enhance generalizability of our findings, 2) incorporate older Veterans’ motivation to change as a key behavioral determinant, 3) use remote delivery to enhance reach of both pain and mental health services to older Veterans; and 4) involved older Veterans and other stakeholders at every stage of development. Specific Aims: We propose a hybrid type 1 implementation-effectiveness randomized controlled trial at two large VA sites to establish the effectiveness and scalability of MOTIVATE. The overall goals of this study are to 1) examine the effectiveness of MOTIVATE compared to a waitlist control arm on clinical and behavioral outcomes; 2) explore implementation processes for the MOTIVATE intervention, and 3) evaluate preliminary cost with a budget impact analysis for MOTIVATE in older Veterans with chronic MSK pain and depressive symptoms. We hypothesize that MOTIVATE will improve clinical and behavioral outcomes in this population. Methodology: We will recruit older Veterans with MSK pain and depressive symptoms (n=264) to determine effectiveness of MOTIVATE versus waitlist control arm to improve clinical and behavioral outcomes at 3 (primary endpoint) and 6 months post-enrollment. The primary outcome is pain interference (a subscale of the Brief Pain Inventory) and secondary outcomes include depressive symptoms (PHQ-9), pain intensity, arthritis self-efficacy, pain catastrophizing Scale, PROMIS scales (including sleep), resilience, frailty, and Global Impression of Change. Using intent-to treat analyses, we will compare MOTIVATE and waitlist groups in terms of primary and secondary outcomes by using a linear mixed-effects model which simultaneously models all available measurements including baseline. Concurrently we will examine implementation processes of delivering MOTIVATE (Aim 2). Using semi-structured interviews, we will explore the contextual factors, barriers and facilitators to implementation and uptake of MOTIVATE, among Veterans, frontline providers, health coaches, and facility leaders (n~50). We will use the i-PARIHS implementation framework to inform the discussion guide. Aim 3 will provide necessary cost evaluation of MOTIVATE along with budget impact analysis from the perspective of a VA facility to estimate the costs of implementing MOTIVATE. Implementation/Next Steps: Results will facilitate national implementation and dissemination of MOTIVATE, along with a hybrid type 3 trial, which can augment the care provided by primary care, mental health, and specialty services to improve outcomes in older Veterans with comorbid MSK pain and depressive symptoms.

背景：肌肉骨骼（MSK）疼痛是残疾和生活质量降低的主要原因 老年人。我们还知道，抑郁症状经常与MSK疼痛共存并复杂化 管理。尽管成本上升归因于MSK疼痛和抑郁症状，但行为很少 已经开发了干预措施来解决这种脆弱的老龄化人群中的这些合并状况。 意义：PI在她的VA HSR＆D CDA2期间开发并测试了新型行为的可行性 干预措施针对老年退伍军人，患有慢性背痛和抑郁症状。激励（转向 改善老年退伍军人的疼痛和抑郁）纳入了激励性的循证成分 采访（MI），价值启发，目标设定和患者激活年龄较大的退伍军人成为 更加身体活跃，从而改善疼痛干扰，功能和抑郁症状。动力是 由健康教练通过电话或视频交付的八个超过12周。初步发现 从PI正在进行的动力试验试验中，这是可行的，可以改善步骤计数，疼痛干扰和 抑郁症状。为了响应VA HSR＆D研究优先领域，该应用程序着重于改进 获得护理，增加初级保健实践的资源 - 特别是在痛苦领域 管理和老化，并利用虚拟护理为弱势退伍军人提供行为干预。 创新/影响：这项研究具有创新性，因为我们1）针对MSK疼痛和抑郁症 症状并提高我们发现的普遍性，2）纳入老年退伍军人的改变动力 关键行为确定器，3）使用远程交付来增强疼痛和心理健康服务的影响 给年长的退伍军人； 4）在发展的每个阶段都涉及老年退伍军人和其他利益相关者。 具体目的：我们提出了两个在两个处的混合型实施效应随机对照试验 大型VA站点以建立激励的有效性和可扩展性。这项研究的总体目标是 1）检查与临床和行为的候补控制臂相比，请检查动力的有效性 结果； 2）探索激励干预的实施过程，3）评估初步 具有预算影响分析的成本，以激发长期MSK疼痛和抑郁症的老年退伍军人 症状。我们假设动力将改善该人群的临床和行为结果。 方法论：我们将招募有MSK疼痛和抑郁症状的老年退伍军人（n = 264） 动机和候补控制臂的有效性，以改善3 （主要终点）和六个月后注册。主要结果是痛苦的干扰（ 简短的疼痛清单）和次要结果包括抑郁症状（PHQ-9），疼痛强度，关节炎 自我效能感，疼痛灾难性量表，Promis量表（包括睡眠），弹性，脆弱和全球 变革的印象。使用意图进行治疗分析，我们将用术语比较激励和候补组 通过使用线性混合效应模型的主要和次要结果，该模型同时建模所有 可用的测量包括基线。同时我们将研究 提供动力（目标2）。使用半结构化访谈，我们将探索上下文因素，障碍 以及在退伍军人，一线提供者中，促进和吸收动力的促进者 教练和设施领导者（n〜50）。我们将使用I-Parihs实施框架来告知 讨论指南。 AIM 3将提供必要的动力评估以及预算影响 从VA设施的角度进行分析，以估算实施激励的成本。 实施/下一步：结果将促进国家的实施和传播动力， 以及Hybrid 3型试验，可以增加初级保健，心理健康和 专业服务可改善合并MSK疼痛和抑郁症状的老年退伍军人的预后。