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Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center

Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center
范德比尔特-西弗吉尼亚州 (VWV) 合作:HOPE 联盟临床中心
批准号:
9902582
负责人:
Kerri Cavanaugh
金额:
$286.33万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-09-24 至 2024-05-31
关键词:
Academic Medical CentersAdultAffectAgreementApplications GrantsAreaAwardBehavior TherapyBone DiseasesCaregiversCaringCenters for Disease Control and Prevention (U.S.)ClinicClinicalCognitive TherapyCollaborationsComplexDataDiabetes MellitusDialysis patientsDialysis procedureDoseEmotionalEnd stage renal failureEtiologyFosteringFutureGoalsGuidelinesHemodialysisHospitalizationImpairmentInjuryIntegrative MedicineInterventionKidney DiseasesLife ExperienceMaintenanceMethodsMorbidity - disease rateMotivationNational Institute of Diabetes and Digestive and Kidney DiseasesNociceptionOpioidOutcomePainPain managementPatient CarePatient Outcomes AssessmentsPatientsPeripheral Vascular DiseasesPharmacologyPharmacotherapyPhysiologicalQuality of lifeRandomized Clinical TrialsRandomized Controlled TrialsRecommendationReportingResearchResearch PersonnelScheduleSiteTechniquesTelemedicineTestingTherapeuticTissuesUnited States National Institutes of HealthUniversitiesWest Virginiaarmchronic painclinical practicecomparative effectivenessdepressive symptomsdesignefficacy trialexpectationexperienceimplementation researchimprovedimproved outcomeinnovationinterestintervention programmeetingsmembermindfulnessmortalitymortality riskmotivational enhancement therapymulti-site trialmultidisciplinarymultimodalitymultiple chronic conditionsnon-cancer chronic painnovelopioid usepain outcomepainful neuropathypatient orientedpragmatic trialprescription opioidpsychologicrandomized trialrecruitresponsesafety and feasibilitysafety studyshared decision makingtreatment strategy

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中文摘要
翻译
超过50%的成年中心血液透析患者经历并接受了非癌症慢性疼痛的治疗 (NCCP)。治疗方法通常是复杂的,因为疼痛的根本病因本身就有助于 身体和心理障碍的结合。缺乏具体的研究证据 血液透析指导药物治疗的最佳方法或其他创新策略以支持 以患者为中心的综合疼痛管理,减少药物治疗和治疗的并发症 总体发病率。作为血液透析阿片类药物处方努力(HOPE)的临床中心成员 财团,这项提案的总体目标是与不同的利益相关者合作,设计和 进行一项多点试验,评估减少阿片类药物剂量、提高生活质量和 在接受中心血液透析的成人中进行专门针对疼痛管理的护理经验。我们建议 具体地说,进行务实的平行ARM试验,以测试添加12周互动视频的影响 认知行为疗法(IV-CBT)干预方案与疾控中心指南的一致性共享 NCCP药物治疗管理决策(SDM)。具体目标是:目标1进行a 在15个月内接受静脉-CBT和SDM与单独接受SDM的多点随机试验;患者将 在基线、12周、9个月和15个月进行评估;目标2调查和描述障碍和 在患者、临床医生和透析工作人员中实施IV-CBT和SDM的促进者;目标3 创建调查人员和透析设施的协作网络,以高效、快速地招募受试者 并传播优化透析中疼痛护理的成功战略。在AIM 2中,申请者将 调查与应用执行综合框架的干预措施有关的因素 研究(CFIR),并为实施工具包制定建议,以指导未来的传播 每一种策略。这项研究具有创新性,因为:i)它寻求将当前的临床实践 SDM持续集成到疼痛管理临床实践中;ii)利用远程医疗来支持 心理和情感支持策略,以促进多通道策略的动机和维持 用于慢性疼痛护理;以及iii)在现实世界环境中对患有多种疾病的患者进行试验,这些患者经常 被排除在试验之外,是新颖的,具有更大的外部有效性。预计这一结果将产生重大影响 积极的影响,因为它们将增加对临床的了解,并强调多学科的重要性 慢性疼痛管理策略,以应对改善患者发病率和 在一个高度普遍和复杂的护理领域中的生活质量。
英文摘要
More than 50% of adult in-center hemodialysis patients experience and are treated for non-cancer chronic pain (NCCP). The treatment approach is often complex as the underlying etiology of the pain itself contributes to a combination of physical and psychological impairments. There is a paucity of research evidence specific to hemodialysis to guide the optimal approaches to pharmacotherapy or other innovative strategies to support patient-centered comprehensive pain management to reduce complications of pharmacologic therapy and morbidity overall. As a clinical center member of the Hemodialysis Opioid Prescription Effort (HOPE) Consortium, the overall objective of this proposal is to collaborate with diverse stakeholders to design and conduct a multi-site trial evaluating innovative strategies to reduce opioid dosing, improve quality of life and experience with care specific to pain management among adults receiving in-center hemodialysis. We propose specifically to perform a pragmatic parallel arm trial to test the impact of adding a 12-week interactive video cognitive behavioral therapy (IV-CBT) intervention program, compared to CDC guideline concordant shared decision-making (SDM) for NCCP pharmacotherapy management. The specific aims are: Aim 1 Conduct a multi-site randomized trial to receive IV-CBT and SDM versus SDM alone over 15 months; patients will be assessed at baseline, 12 weeks, 9 months and 15 months; Aim 2 Investigate and describe barriers and facilitators of the implementation of IV-CBT and also SDM among patients, clinicians and dialysis staff; Aim 3 Create a collaborative network of investigators and dialysis facilities for efficient and swift subject recruitment and for dissemination of successful strategies to optimize pain care in dialysis. In Aim 2, applicants will investigate factors related to the interventions applying the Consolidated Framework for Implementation Research (CFIR), and develop recommendations for an implementation toolkit to guide future dissemination of each of the strategies. The research is innovative because: i) it seeks to shift current clinical practice where SDM is consistently integrated into pain management clinical practice; ii) telemedicine is leveraged to support psychological and emotional support strategies to foster motivation and maintenance of multimodal strategies for chronic pain care; and iii) a trial in real-world settings of patients with multi-morbidity, who are regularly excluded from trials, is novel and has greater external validity. The results are expected to have a major positive impact as they will increase clinical understanding and underscore the importance of multidisciplinary chronic pain management strategies in tackling on the significant challenge of improving patient morbidity and quality of life in a highly prevalent and complex area of care.
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