2/2: IMPACt-LBP DCC

2/2：IMPACt-LBP DCC

基本信息

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
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/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

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关键来源，影响了3100万美国人任何给定的时间，每年的医疗保健总费用为100-2000亿美元。 LBP是领先的向美国医生访问门诊护理的原因；不幸的是，这些访问通常会导致治疗阿片类药物可能导致弊大于利。 2017年美国医师学院（ACP）指南对于LBP，建议的患者接受非药物干预措施作为一线治疗，但停止了除了提供有关如何将这种治疗纳入常规患者护理中的解决方案。存在用于多学科协作护理的路线图，其中包括脊椎治疗和身体医生治疗师，训练有素的初级接触临床医生，具有特定专业知识在治疗肌肉骨骼条件，作为LBP的第一行提供商。这些临床医生通常使用许多非药理学 ACP指南推荐的方法，包括脊柱操纵和运动。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，并导致身体功能改善，减轻疼痛，更少的阿片类药物处方以及减少的利用率医疗服务。但是，这种LBP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 LBP（MC2LBP）3个学术保健系统（HCS）的协作护理模型，然后评估其通过将18岁及以上患者患有LBP的患者的常规医疗服务进行比较，有效。项目研究目标的完成将从一年的UG3计划阶段开始，涉及完成22 两类分阶段活动的里程碑 - 模型实施和临床试验设计。 UH3研究的目的将使用务实的，簇的临床试验设计来完成。该研究将进行管理通过临床协调中心和数据协调中心，都位于杜克临床研究所与达特茅斯 - 希区柯克医学中心和爱荷华大学合作。在计划阶段，我们将跨三个HC构建实施基础设施，最终确定临床试验协议，并完成从UG3过渡到UH3阶段所需的任务。 UH3阶段将用于：1）操作促进的新组织政策和程序的集成在干预诊所实施MC2LBP； 2）确定MC2LBP与通常的护理； 3）估计和比较医疗资源的使用以及实施MC2LBP的成本；和4）评估患者，提供者，系统和政策级别的障碍以及实施MC2LBP的促进者混合方法，过程评估方法。这项研究的结果有可能告知未来实施和政策努力，以改善患有LBP患者的疼痛管理质量同时减少阿片类药物处方，医疗保健成本和服务利用。