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1/2 IMPACt-LBP CCC

基本信息

批准号：
10093277
负责人：
Adam Goode
金额：
$ 95.84万
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 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10093277
关键词：
Adult Age Ambulatory Care American American College of Physicians Caring Categories Chronic low back pain Client satisfaction Clinic Clinical Clinical Research Clinical Trials Design Clinical trial protocol document Cluster randomized trial Collaborations Data Coordinating Center Doctor of Chiropractic Documentation Drug Prescriptions Emergency department visit Evaluation Exercise Focus Groups Foundations Future Goals Guidelines Health Care Costs Health system Healthcare Systems Hospitalization Infrastructure Injections Intervention Interview Iowa Lead Low Back Pain Measures Medical Medical Care Costs Medical center Methods Modeling Musculoskeletal Operative Surgical Procedures Opioid Organizational Policy Pain Pain interference Pain management Pain quality Patient Care Patients Phase Physical Function Physicians Policies Primary Health Care Procedures Process Protocols documentation Provider Quality-Adjusted Life Years Randomized Clinical Trials Randomized Controlled Trials Reporting Research Design Research Institute Resources Risk Site Source Spinal Fusion Spinal Manipulation Standardization Surveys System Testing Time Training Universities Visit Work base care providers chronic pain clinical research site collaborative care comparative effectiveness compare effectiveness cost disability impact effectiveness testing experience functional status health care service utilization health service use implementation facilitation implementation trial improved incremental cost-effectiveness informant member multidisciplinary opioid epidemic opioid mortality opioid use pain reduction physical therapist prescription opioid primary endpoint primary outcome secondary outcome service utilization symptom treatment treatment as usual uptake

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主要来源，影响着3100多万美国人在任何给定的时间内，每年都会产生1,000-2,000亿美元的总医疗成本。LBP是领先的导致门诊护理就诊的美国医生；不幸的是，这些就诊经常导致治疗，如可能弊大于利的阿片类药物。2017年美国医师学会(ACP)指南对于推荐的LBP患者，将非药物干预作为一线治疗，但已停止缺乏关于如何将这些治疗融入常规患者护理的解决方案。多学科协作护理的路线图已经存在，其中包括脊椎按摩和理疗医生治疗师，训练有素的初级接触临床医生，在肌肉骨骼治疗方面具有特定专业知识条件，作为LBP的一线提供者。这些临床医生例行公事地雇用许多非药理学的 ACP指南推荐的方法，包括脊柱手法和锻炼。重要研究小组成员进行的基础性工作表明，这种护理是可行的、安全的、并导致改善身体功能，减轻疼痛，减少阿片类药物处方，并减少对医疗保健服务。然而，这种治疗LBP的方法尚未得到广泛的实施或验证使用严谨的科学方法。我们的总体目标是完善和实施多学科 3种学术卫生保健系统中的LBP协作护理模型(MC2LBP)及其评价通过将其与18岁及以上患有LBP的患者的常规医疗护理进行比较，得出其有效性。完成项目研究的目标将从为期一年的UG3规划阶段开始，包括完成22 两类阶段性活动的里程碑--模型实施和临床试验设计。UH3研究目标将使用务实的、整群随机的临床试验设计来完成。这项研究将得到管理通过临床协调中心和数据协调中心，这两个中心都位于杜克临床该研究所与达特茅斯-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HC中构建实施基础设施，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)实现新组织政策和程序的集成，以促进 MC2LBP在干预诊所的实施情况；2)比较MC2LBP与日常护理；3)估计和比较实施MC2LBP的医疗资源使用和成本；以及4) 评估患者、提供者、系统和政策层面实施MC2LBP的障碍和促进者，使用混合法、过程性评价法。这项研究的结果有可能为未来改善下腰痛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率。