2/2: IMPACt-LBP DCC

2/2：IMPACt-LBP DCC

基本信息

批准号：
10447570
负责人：
Hrishikesh Chakraborty
金额：
$ 68.98万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10447570
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 Exercise Feasibility Studies Foundations 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 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 future implementation 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 process evaluation public repository secondary endpoint service utilization standard care treatment as usual web site

项目摘要

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.

腰痛 (LBP) 是医疗费用和残疾的一个重要根源，影响着超过 3100 万美国人任何特定时间，每年都会产生 100 至 2000 亿美元的医疗保健总成本。 LBP 是领先的之一美国医生门诊就诊的原因；不幸的是，这些访问通常会导致诸如以下的治疗：阿片类药物弊大于利。 2017年美国医师学会（ACP）指南对于腰痛，建议患者接受非药物干预作为一线治疗，但停止了缺乏关于如何将此类治疗纳入常规患者护理的解决方案。存在多学科协作护理的路线图，其中包括脊椎按摩医生和物理医生治疗师、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 的一线提供商。这些临床医生经常使用许多非药物手段 ACP 指南推荐的方法，包括脊柱推拿和锻炼。重要的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、从而改善身体机能、减少疼痛、减少阿片类药物处方并减少阿片类药物的使用医疗保健服务。然而，这种腰痛治疗方法尚未得到广泛实施或验证使用严格的科学方法。我们的总体目标是完善和实施多学科 3 个学术医疗保健系统 (HCS) 中的 LBP (MC2LBP) 协作护理模型，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来确定其有效性。项目研究目标的完成将从为期一年的 UG3 规划阶段开始，其中包括完成 22 两类分阶段活动的里程碑——模型实施和临床试验设计。 UH3研究目标将使用务实的整群随机临床试验设计来完成。该研究将被管理通过位于杜克临床中心的临床协调中心和数据协调中心研究所与达特茅斯-希区柯克医学中心和爱荷华大学合作。在规划阶段，我们将在三个 HCS 上建立实施基础设施，最终确定临床试验方案，并完成从 UG3 过渡到 UH3 阶段所需的任务。 UH3阶段将用于： 1) 实施整合新的组织政策和程序，以促进在干预诊所实施 MC2LBP； 2) 确定 MC2LBP 与日常护理； 3) 估计并比较医疗资源的使用和实施 MC2LBP 的成本；和 4) 使用以下方法评估实施 MC2LBP 的患者、提供者、系统和政策层面的障碍和促进因素：混合法、过程评价法。这项研究的结果有可能为未来提供信息提高 LBP 患者疼痛管理质量的实施和政策努力同时减少阿片类药物处方、医疗保健成本和服务利用。