2/2: IMPACt-LBP DCC

2/2：IMPACt-LBP DCC

• 批准号: 10092312
• 负责人: Hrishikesh Chakraborty
• 金额: $ 62.01万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10092312
• 关键词: Address; Age; Ambulatory Care; American; American College of Physicians; Caring; Categories; Chronic low back pain; Clinic; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Clinical trial protocol document; Cluster randomized trial; Collaborations; Data; Data Collection; Data Coordinating Center; Data Set; Doctor of Chiropractic; Ensure; Epidural Injections; Evaluation; Exercise; Feasibility Studies; Foundations; Future; Goals; Guidelines; Health Care Costs; Health system; Healthcare Systems; Infrastructure; Intervention; Iowa; Lead; Link; Low Back Pain; Manuscripts; Medical; Medical Care Costs; Medical center; Methods; Modeling; Monitor; Musculoskeletal; Musculoskeletal Pain; Non-Steroidal Anti-Inflammatory Agents; Online Systems; Opioid; Organizational Policy; Outcome; Pain; Pain interference; Pain management; Pain quality; Patient Care; Patients; Phase; Physical Function; Physicians; Pilot Projects; Policies; Preparation; Procedures; Process; Provider; Publications; Randomized Clinical Trials; Reporting; Research Institute; Research Personnel; Resources; Risk; Safety; Source; Spinal Fusion; Spinal Manipulation; Statistical Data Interpretation; System; Techniques; Time; Training; Universities; Visit; Work; base; care providers; chronic pain; collaborative care; community based participatory research; comparative effectiveness; compare effectiveness; cost; data dissemination; data management; data quality; design; disability; disability impact; effectiveness evaluation; electronic data capture system; experience; health care service utilization; implementation facilitation; implementation trial; improved; innovation; meetings; member; multidisciplinary; opioid epidemic; opioid mortality; opioid use; pain patient; pain reduction; physical therapist; pragmatic trial; prescription opioid; public repository; secondary endpoint; service utilization; standard care; treatment as usual; web site

Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at any given time and resulting in $100-$200 billion per year in total healthcare costs. LBP is one of the leading causes of ambulatory care visits to US physicians; unfortunately, these visits often result in treatments such as opioids that can lead to more harm than benefit. In 2017 the American College of Physicians (ACP) guideline for LBP recommended patients receive non-pharmacological interventions as a first-line treatment but stopped short of offering solutions regarding how such treatments should be integrated into routine patient care. Roadmaps exist for multi-disciplinary collaborative care that includes doctors of chiropractic and physical therapists, well-trained primary contact clinicians with specific expertise in the treatment of musculoskeletal conditions, as first line providers for LBP. These clinicians routinely employ many of the non-pharmacological approaches recommended by the ACP guideline, including spinal manipulation and exercise. Important foundational work conducted by members of the study team has demonstrated that such care is feasible, safe, and results in improved physical function, less pain, fewer opioid prescriptions, and reduced utilization of healthcare services. However, this treatment approach for LBP has yet to be widely implemented or validated using rigorous scientific methods. Our overarching goal is to refine and implement a multidisciplinary collaborative care model for LBP (MC2LBP) in 3 academic Health Care Systems (HCS) and then evaluate its effectiveness by comparing it to usual medical care in patients age 18 and older suffering from LBP. Completion of project study aims will begin with a one-year UG3 planning phase involving completion of 22 milestones in 2 categories of phased activities - model implementation and clinical trial design. UH3 study aims will be accomplished using a pragmatic, cluster-randomized, clinical trial design. The study will be managed through a Clinical Coordinating Center and Data Coordinating Center, both housed at the Duke Clinical Research Institute, in collaboration with Dartmouth-Hitchcock Medical Center and the University of Iowa. During the planning phase, we will build implementation infrastructure across three HCS, finalize the clinical trial protocol, and complete the tasks necessary to transition from the UG3 to UH3 phase. The UH3 phase will be used to: 1) Operationalize the integration of new organizational policies and procedures required to facilitate implementation of MC2LBP at intervention clinics; 2) Determine the comparative effectiveness of MC2LBP vs usual care; 3) Estimate and compare medical resource use and costs of implementing MC2LBP; and 4) Evaluate patient, provider, system and policy level barriers and facilitators to implementing MC2LBP, using a mixed method, process evaluation approach. Results from this study have the potential to inform future implementation and policy efforts to improve the quality of pain management for patients suffering from LBP while simultaneously reducing opioid prescriptions, health care costs and utilization of services.

下背痛（LBP）是医疗费用和残疾的主要来源，影响了3100多万美国人， 任何给定的时间，导致每年1000 - 2000亿美元的总医疗费用。LBP是领先的 门诊护理访问美国医生的原因;不幸的是，这些访问往往导致治疗，如 阿片类药物可能弊大于利。2017年，美国医师学会（ACP）指南 对于LBP，建议患者接受非药物干预作为一线治疗，但停止 缺乏关于如何将这种治疗纳入常规患者护理的解决方案。 路线图存在的多学科合作护理，包括脊椎按摩和物理医生 治疗师，训练有素的主要接触临床医生，在肌肉骨骼治疗方面具有特定的专业知识 条件，作为LBP的第一线供应商。这些临床医生经常使用许多非药物 ACP指南推荐的方法，包括脊柱推拿和锻炼。重要 研究小组成员进行的基础工作表明，这种护理是可行的，安全的， 并导致身体功能改善，疼痛减轻，阿片类药物处方减少， 保健服务。然而，这种治疗LBP的方法尚未得到广泛实施或验证 使用严格的科学方法。我们的首要目标是完善和实施一个多学科的 LBP的合作护理模式（MC 2LBP）在3个学术卫生保健系统（HCS），然后评估其 通过将其与18岁及以上LBP患者的常规医疗护理进行比较， 项目研究目标的完成将从为期一年的UG 3规划阶段开始开始， 2类阶段性活动的里程碑-模型实施和临床试验设计。UH 3研究目标 将采用务实的随机分组临床试验设计完成。本研究将由 通过临床协调中心和数据协调中心，两者都设在杜克临床 研究所，与达特茅斯-希区柯克医学中心和爱荷华州大学合作。 在规划阶段，我们将在三个HCS上建立实施基础设施，完成临床 试验方案，并完成从UG 3过渡到UH 3阶段所需的任务。UH 3阶段将 用于：1）实施新的组织政策和程序的整合，以促进 在干预诊所实施MC 2LBP; 2）确定MC 2LBP与 3）估计和比较实施MC 2LBP的医疗资源使用和成本;以及4） 评估患者、提供者、系统和政策层面的障碍以及实施MC 2LBP的促进因素，使用 混合法、过程评价法。这项研究的结果有可能为未来的研究提供信息。 实施和政策努力，以提高LBP患者疼痛管理的质量 同时减少阿片类药物处方、保健费用和服务利用。