AIM BACK UH3 Transition
AIM BACK UH3 Transition
批准号:
10363726
负责人:
STEVEN Z GEORGE
金额:
$155.93万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-09-20 至 2024-02-29
关键词:
AcuteAddressAdherenceAgreementArthritisBackBack PainBehavior TherapyBehavioral SciencesBioinformaticsBiometryCaringCharacteristicsChronicChronic low back painClinicalClinical Practice GuidelineClinical ProtocolsClinical ResearchCluster randomized trialComputerized Patient RecordsCounselingDataData Management ResourcesDiagnostic testsDoctor of PhilosophyEffectivenessElectronic Health RecordEnrollmentEnsureEnvironmentExposure toFeedbackGoalsHealth systemHealthcare SystemsHeterogeneityHomeImageImprove AccessInfrastructureInstitutional Review BoardsInternal MedicineLeadLeadershipLow Back PainMassageMeasuresMedicalMedical centerMedicineMethodsMindNonpharmacologic TherapyNorth CarolinaOperative Surgical ProceduresOutcomePainPain ResearchPain interferencePain managementParticipantPathway interactionsPatient CarePatientsPharmacologyPhasePhysical FunctionPhysical activityPhysical therapyPoliciesPositioning AttributePragmatic clinical trialProceduresProviderPsychiatryReportingResearchResearch DesignResearch InstituteResearch PersonnelResource SharingResourcesRiskRoleSelf ManagementServicesSiteSpinal ManipulationStructureSubgroupSystemTelephoneTestingTrainingTranscutaneous Electric Nerve StimulationUnited States Department of Veterans AffairsUnited States National Institutes of HealthUniversitiesVeteransVeterans Health Administrationbasebiopsychosocialchronic back paincollaboratorycomparative effectivenesscomparative effectiveness trialcompare effectivenessdesigndisabilityhigh riskimprovedmembermilitary veteranmultimodalityopioid exposureopioid injectionpain reductionpain reliefpain scorepilot testprimary outcomeprogramspsychologicpublic health relevanceroutine practicetelephone deliverytooltreatment effecttreatment riskworking group
中文摘要
摘要:改善退伍军人获得慢性背痛综合治疗的机会
LBP是退伍军人最普遍、最致残的医疗问题之一。改善对LBP患者的护理
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
LBP的非药物治疗。然而,涉及非药理学的最佳护理途径
治疗方法尚未确定。与“生物-心理-社会”概念相一致的护理路径
LBP很有价值,但很少在常规实践环境中交付,仍然需要
对其有效性进行了调查。本UG3(规划阶段)/UH3(演示)的总体目标
项目)的提案是改善推荐的非药物治疗LBP的机会
退伍军人健康保健系统系。在UG3阶段,试验计划将通过两个目标完成:1)
针对数据管理和资源共享需求制定政策、程序和监管协议
2)最终确定进行高质量、多中心务实研究所需的研究设计和临床方案
整群随机试验。为UH3示范项目提出的实用整群随机试验
将比较两种LBP管理方法的有效性,旨在增强对非
药理疼痛治疗和面向生物、心理和社会的护理:a)顺序、多模式综合
包含身体疼痛治疗、量身定制的行为治疗和居家活动的护理路径
对比2)Pain Navigator计划的护理管理,便于协调使用现有的VA或非
VA疼痛管理资源。考虑到临床实践指南,这两条路径都是
有目的地构造以包括非药物的疼痛调节。参加试验的退伍军人(n=
1,250)将遵循主要结果(PROMIS简写形式的疼痛干预和功能评分)
从电子健康记录捕获,并且子集(n=630)将完成电话捕获的患者
报告二次增强电子健康记录捕获。在目标1中,我们将检查
LBP的顺序、多模式综合护理路径与Pain Navigator护理管理的比较
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
与护理管理方案相比,具有正常的活动和改善的身体功能。在AIM 2
我们将确定与疼痛干预和更大程度改善相关的参与者特征
功能,并更好地坚持每条护理途径。目标2将告知潜在的匹配老将
亚群特征到特定的护理路径,提供更大的改善疼痛和
功能。该提案直接与NIH-DoD-VA疼痛管理的主要目标保持一致
通过调整现有的退伍军人健康系统资源来扩展能力以提供更早的非
退伍军人LBP的药理学疼痛管理。
英文摘要
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.
期刊论文(0)
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会议论文
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海外基金