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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主要来源，每年影响超过3100万美国人