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AIM BACK UH3 Transition

瞄准回来 UH3 过渡

基本信息

批准号：
10581589
负责人：
STEVEN Z GEORGE
金额：
$ 158.09万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-20 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10581589
关键词：
Acute Address Adherence Agreement Arthritis Back Back Pain Behavior Therapy Behavioral Sciences Bioinformatics Biometry Caring Characteristics Chronic Chronic low back pain Clinical Clinical Practice Guideline Clinical Protocols Clinical Research Cluster randomized trial Computerized Patient Records Counseling Data Diagnostic tests Dimensions Doctor of Philosophy Effectiveness Electronic Health Record Enrollment Ensure Environment Exposure to Feedback Goals Health system Healthcare Systems Heterogeneity Home Image Improve Access Infrastructure Injections Institution Institutional Review Boards Internal Medicine Lead Leadership Low Back Pain Managed Care Managed Care Programs Massage Measures Medical Medical center Medicine Methods Mind Nonpharmacologic Therapy North Carolina Operative Surgical Procedures Opioid Outcome Pain Pain Research Pain interference Pain management Participant Pathway interactions Patient Care Patients Phase Physical Function Physical activity Physical therapy Policies Positioning Attribute Practice Guidelines Pragmatic clinical trial Procedures Provider Psychiatry Recommendation Reporting Research Research Design Research Institute Research Personnel Resources Risk Role Self Management Services Site Spinal Manipulation Structure Subgroup System Telephone Testing Training Transcutaneous Electric Nerve Stimulation United States Department of Veterans Affairs United States National Institutes of Health Universities Veterans Veterans Health Administration base biopsychosocial collaboratory comparative effectiveness comparative effectiveness trial compare effectiveness data management data sharing networks design disability effectiveness evaluation high risk improved integrated care member military veteran multimodality opioid exposure pain reduction pain relief pain score pharmacologic pilot test primary outcome programs psychologic public health relevance routine practice telephone delivery tool treatment effect treatment risk trial planning working group

项目摘要

ABSTRACT: Improving Veteran Access to Integrated Management of Chronic Back Pain LBP is among the most prevalent and disabling medical problems for Veterans. Improving patient care for LBP is a high priority for many federal agencies and recent clinical practice guidelines emphasize the importance of non-pharmacological management of LBP. However, optimal care pathways involving non-pharmacological treatments have not been established. Care pathways aligned with a “biopsychosocial” conceptualization of LBP are highly valued, but are rarely delivered in routine practice environments and still need to be investigated for their effectiveness. The overall goal of this UG3 (Planning Phase)/UH3 (Demonstration Project) proposal is to improve access to recommended non-pharmacologic therapies for LBP in the Department of VA Health Care System. In UG3 phase trial planning will be accomplished through two aims: 1) establish policies, procedures, and regulatory agreements for data management and resource sharing needs and 2) finalize research design and clinical protocols needed to conduct a high-quality, multi-center pragmatic cluster randomized trial. The pragmatic cluster randomized trial proposed for the UH3 Demonstration Project will compare the effectiveness of two LBP management approaches designed to enhance access to non- pharmacological pain treatments and biopsychosocial oriented care: a) sequenced, multi-modal integrated care pathway incorporating physical pain treatment, tailored behavioral treatment, and home base activity versus 2) care management by pain navigator program that facilitates coordinated use of existing VA or non- VA pain management resources. With clinical practice guidelines in mind, both pathways have been purposefully structured to include non-pharmacological pain modulation. Veterans enrolled in the trial (n = 1,250) will be followed for primary outcomes (PROMIS Short Form scores for pain interference and function) captured from the electronic health record and a subset (n = 630) will complete phone captured patient reported secondary augment electronic health record capture. In Aim 1 we will examine the effectiveness of a sequenced, multi-modal integrated care pathway for LBP, compared to a care management by pain navigator program. Our central hypothesis is that the multi-modal, integrated care pathway will reduce pain interference with normal activities and improve physical function compared with the care management program. In Aim 2 we will determine participant characteristics associated with greater improvements in pain interference and function, and better adherence to each care pathway. Aim 2 will inform the potential for matching Veteran subgroup characteristics to a specific care pathway that provides greater potential for improvement in pain and function. This proposal is directly aligned with primary goals of the NIH-DoD-VA Pain Management Collaboratory by aligning existing VA health system resources to expand capacity to deliver earlier non- pharmacological pain management for the Veteran with LBP.

摘要：改善退伍军人对慢性背痛的综合管理 LBP是退伍军人最普遍和最致残的医疗问题之一。改善LBP患者护理是许多联邦机构的高度优先事项，最近的临床实践指南强调了以下重要性： LBP的非药物管理。然而，涉及非药物治疗的最佳护理途径治疗方法尚未建立。护理途径与“生物心理社会”概念化相一致， LBP是非常有价值的，但很少在常规实践环境中提供，仍然需要调查其有效性。本UG 3（规划阶段）/UH 3（演示）的总体目标项目）的建议是改善获得推荐的非药物治疗LBP在 VA卫生保健系统部门。在UG 3阶段，试验计划将通过两个目标完成：1）为数据管理和资源共享需求制定政策、程序和监管协议和2）最终确定进行高质量，多中心务实的研究设计和临床协议集群随机试验。UH 3示范项目的实用性整群随机试验将比较两种LBP管理方法的有效性，这些方法旨在提高非药物疼痛治疗和生物心理社会导向的护理：a）有序的，多模式的综合结合物理疼痛治疗、定制行为治疗和家庭活动的护理路径对比2）通过疼痛导航程序进行护理管理，促进协调使用现有VA或非VA 疼痛管理资源考虑到临床实践指南，这两种途径都已有目的地构造成包括非药理学疼痛调节。入组试验的退伍军人（n = 1，250）将随访主要结局（疼痛干扰和功能的PROMIS简表评分）从电子健康记录中采集，一个子集（n = 630）将完成电话采集患者报告了二次垫块电子健康记录捕获。在目标1中，我们将研究 LBP的有序、多模式综合护理路径，与疼痛导航仪护理管理相比程序.我们的中心假设是，多模式，综合护理路径将减少疼痛干扰与正常活动和改善身体机能的护理管理方案相比。在目标2中我们将确定与疼痛干预的更大改善相关的参与者特征，更好地坚持每一条护理路径。目标2将告知匹配退伍军人的可能性亚组特征的特定护理途径，提供更大的改善疼痛的潜力，功能该提案与NIH-DoD-VA疼痛管理的主要目标直接一致通过调整现有退伍军人管理局卫生系统资源，开展合作，扩大能力，药物疼痛管理的退伍军人与LBP。