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

背景：肌肉骨骼（MSK）疼痛是残疾和生活质量下降的主要原因， 老年人我们也知道抑郁症状经常与MSK疼痛共存， 管理尽管由于肌肉骨骼肌疼痛和抑郁症状而导致成本上升，但很少有行为 已经制定了干预措施，以解决这一脆弱的老龄人口中的这些共病状况。 意义：PI在VA HSR&D CDA 2期间，开发并测试了一种新的行为 针对患有慢性背痛和抑郁症状的老年退伍军人的干预。动机（走向 改善老年退伍军人的疼痛和抑郁症）纳入了基于证据的动机成分， 访谈（MI），价值观启发，目标设定和患者激活，以激励老年退伍军人成为 更多的身体活动，从而改善疼痛干扰，功能和抑郁症状。动机是 由健康教练通过电话或视频在12周内的8次会议上提供。初步调查结果 PI正在进行的MOTIVATE试点试验表明，它是可行的，改善了步数，疼痛干扰， 抑郁症状针对VA HSR&D研究的优先领域，本申请侧重于提高 获得护理，增加初级保健实践的资源-特别是在疼痛领域 管理和老龄化，并利用虚拟护理为弱势退伍军人提供行为干预。 创新/影响：这项研究是创新的，因为我们1）针对MSK疼痛和抑郁 症状，并提高我们的研究结果的普遍性，2）将老年退伍军人的动机改变， 一个关键的行为决定因素，3）使用远程交付，以提高疼痛和心理健康服务的覆盖面 老年退伍军人;和4）涉及老年退伍军人和其他利益相关者在每个发展阶段。 具体目的：我们提出了一项混合型1实施效果随机对照试验， 大型VA站点，以建立MOTIVATE的有效性和可扩展性。本研究的总体目标是 1)检查MOTIVATE与等待名单对照组相比在临床和行为方面的有效性 结果; 2）探索动机干预的实施过程，以及3）评估初步的 慢性MSK疼痛和抑郁的老年退伍军人的动机的预算影响分析 症状我们假设MOTIVATE将改善这一人群的临床和行为结局。 方法：我们将招募患有MSK疼痛和抑郁症状的老年退伍军人（n=264），以确定 3岁时MOTIVATE与等待列表对照组改善临床和行为结局的有效性 （主要终点）和入组后6个月。主要结果是疼痛干扰（ 简明疼痛量表）和次要结局包括抑郁症状（PHQ-9）、疼痛强度、关节炎 自我效能、疼痛灾难化量表、PROMIS量表（包括睡眠）、复原力、虚弱和整体 变化的印象。使用意向治疗分析，我们将比较动机组和等待名单组在条款 使用线性混合效应模型，同时模拟所有 包括基线在内的可用测量值。同时，我们将审查 传递动机（目标2）。使用半结构化访谈，我们将探讨背景因素，障碍， 和促进者，以实施和吸收动机，退伍军人，前线供应商，卫生 教练和设施负责人（n~50）。我们将使用i-PARIHS实施框架， 讨论指南。目标3将提供必要的动机成本评估以及预算影响沿着 从VA设施的角度进行分析，以估计实施MOTIVATE的成本。 执行/今后的步骤：取得的成果将促进国家执行和传播激励措施， 沿着混合型3型试验，该试验可以增加初级保健、精神健康和 专业服务，以改善患有MSK疼痛和抑郁症状的老年退伍军人的结局。

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.