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) 疼痛是导致残疾和生活质量下降的主要原因 我们还知道，抑郁症状经常与 MSK 斯隆疼痛同时存在，并使情况变得复杂。 尽管 MSK 斯隆疼痛和抑郁症状造成的费用不断上升，但行为管理却很少。 已经制定了干预措施来解决脆弱的老龄化人群中的这些合并症。 意义：PI 在 VA HSR&D CDA2 期间开发并测试了行为小说的可行性 针对患有慢性背痛和抑郁症状的老年退伍军人的干预措施（转向） 改善老年退伍军人的疼痛和抑郁）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 更加积极地进行身体活动，从而改善疼痛干扰、功能和抑郁症状。 由健康教练在 12 周的八次会议中通过电话或视频提供初步调查结果。 PI 正在进行的 MOTIVATE 试点试验表明它是可行的，可以改善步数、减轻疼痛干扰，并且 为了响应 VA HSR&D 研究的优先领域，该应用程序侧重于改善抑郁症状。 获得护理，增加初级护理实践的资源——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：这项研究具有创新性，因为我们 1) 针对 MSK 斯隆疼痛和抑郁 症状并增强我们研究结果的普遍性，2）将老年退伍军人的改变动机纳入 一个关键的行为决定因素，3) 使用远程交付来扩大疼痛和心理健康服务的覆盖范围 老年退伍军人；4) 让老年退伍军人和其他利益相关者参与各个发展阶段。 具体目标：我们提出了一项混合 1 型实施效果随机对照试验，时间为 2 大型 VA 站点以确定 MOTIVATE 的有效性和可扩展性 本研究的总体目标是 1) 检查 MOTIVATE 与候补对照组相比在临床和行为方面的有效性 结果；2) 探索 MOTIVATE 干预的实施过程，以及 3) 评估初步结果 对患有慢性 MSK 疼痛和抑郁的老年退伍军人进行 MOTIVATE 的成本和预算影响分析 我们追求 MOTIVATE 将改善该人群的临床和行为结果。 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) 来确定 MOTIVATE 与等候名单控制组在改善临床和行为结果方面的有效性 3 （主要终点）和入组后 6 个月的主要结局是疼痛干扰（该指标的一个子量表）。 简要疼痛量表）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、疼痛灾难化量表、PROMIS 量表（包括睡眠）、复原力、脆弱性和整体性 使用意图治疗分析，我们将比较 MOTIVATE 组和候补组。 通过使用线性混合效应模型来同时模拟所有结果 同时，我们将检查包括基线在内的可用测量结果。 通过半结构化访谈，我们将探索情境因素和障碍。 以及退伍军人、一线提供者、卫生部门实施和采用 MOTIVATE 的促进者 教练和设施领导 (n~50) 我们将使用 i-PARIHS 实施框架来通知 目标 3 将提供必要的 MOTIVATE 成本评估​​以及预算影响。 从 VA 设施的角度进行分析，以估计实施 MOTIVATE 的成本。 实施/后续步骤：结果将促进 MOTIVATE 的全国实施和传播， 以及混合 3 型试验，可以增强初级保健、心理健康和 专业服务可改善患有 MSK 斯隆疼痛和抑郁症状的老年退伍军人的治疗结果。