Pain Reduction and Opioid MedIcation Safety in ESRD (PROMISE) study

ESRD (PROMISE) 研究中的疼痛减轻和阿片类药物用药安全性

基本信息

批准号：
9901704
负责人：
Manisha Jhamb
金额：
$ 284.75万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-24 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9901704
关键词：
Address Agreement Analgesics Anxiety Behavior Therapy Behavioral Brief Pain Inventory Buprenorphine Care given by nurses Case Manager Chronic Clinical Cognitive Therapy Collaborations Comorbidity Data Dialysis procedure Dose Effectiveness Effectiveness of Interventions Electronic Health Record End stage renal failure Evidence based intervention Evidence based treatment Future Goals Hemodialysis High Prevalence Hospitalization Hybrids Intervention Kidney Long-Term Effects Malignant Neoplasms Medicare Mental Depression Methodology Methods Modeling Morbidity - disease rate Nephrology Opioid Opioid agonist Outcome Pain Pain management Patient Care Patient Outcomes Assessments Patient-Focused Outcomes Patients Pennsylvania Pharmacy facility Policies Population Primary Care Physician Process Provider Randomized Randomized Controlled Trials Reporting Resources Risk Safety Safety Management Severities Site Telemedicine Testing Time United States National Institutes of Health Universities Work addiction base care providers collaborative care design evidence base flexibility health related quality of life implementation research improved insight medication safety mindfulness mortality novel opioid epidemic opioid use pain outcome pain reduction personalized approach personalized management prescription opioid primary outcome psychologic psychological symptom recruit satisfaction secondary outcome tool treatment as usual treatment optimization usual care arm

项目摘要

Abstract More than half of end-stage renal disease (ESRD) patients on hemodialysis (HD) report debilitating pain, which is associated with poor health-related quality of life, increased hospitalizations and mortality. Often, their pain is managed poorly and ineffectively. Additionally the high prevalence of opioid use in these patients increases their risk of hospitalizations and mortality. The overall goal of the proposed Pain Reduction and Opioid Medication Safety in ESRD (PROMISE) study is to improve safety of opioid use and pain management in HD patients using a Type I effectiveness-implementation hybrid design. In this multi-site randomized controlled trial of 560 HD patients from the Hemodialysis Opioid Prescription Effort (HOPE) Consortium, we will use a 2x2 factorial design to examine the effectiveness of two separate 9- month evidence-based interventions: 1) Opioid Tapering Management (OTM), and 2) Behavioral Pain Management (BPM). The OTM intervention consists of a collaborative care model in which a nurse care manager works closely with patients, primary care physicians (PCPs) and dialysis teams to develop and manage an individualized approach for analgesic optimization with focus on opioid tapering or transition to buprenorphine in all patients after consensual agreement with patient and PCP. The BPM combines two evidence based treatments - Acceptance and Commitment Therapy (ACT) for pain and Cognitive Behavioral Therapy (CBT) for co-existing depression/anxiety (when present) and is delivered via telemedicine during HD. The control condition not assigned to either OTM or BPM will be usual care and have the option to receive ACT at the end of 12 months. We will examine the effectiveness of OTM (versus no OTM, Aim 1) and BPM (versus no BPM, Aim 2) over 9-months for reducing opioid use (primary outcome) and improving pain severity (secondary outcome) in HD patients on chronic opioids. The implementation goal will take advantage of the diverse patient, provider and organizational settings in the HOPE Consortium to evaluate process outcomes for from multiple stakeholders (Aim 3). Our study combines novel tools and resources to decrease opioid related morbidity, address the opioid epidemic, alleviate pain for HD patients, in addition to providing insights to inform integration of these interventions into dialysis practice and policy.

抽象的血液透析（HD）报告的终末期肾脏疾病（ESRD）的一半以上与健康相关的生活质量差有关的使人衰弱的疼痛增加了住院和死亡率。通常，他们的疼痛受到良好和无效的治疗。此外这些患者中阿片类药物使用的高流行率增加了住院的风险和死亡。提议减轻疼痛和阿片类药物安全性的总体目标 ESRD（承诺）研究是为了提高阿片类药物使用和HD疼痛管理的安全性使用I型有效性实施混合设计的患者。在这个多站点随机的来自血液透析阿片类药物处方工作的560名HD患者的对照试验（Hope）财团，我们将使用2x2阶乘设计来检查两个单独的9-- 基于证据的月份干预措施：1）阿片类药物锥度管理（OTM）和2）行为疼痛管理（BPM）。 OTM干预包括协作护理护士护理经理与患者，初级保健医生紧密合作的模型（PCP）和透析团队开发和管理一种个性化的镇痛方法优化，重点是在所有患者中的阿片类药物逐渐减少或过渡到丁丙诺啡与患者和PCP的共识。 BPM结合了两个证据治疗 - 疼痛和认知行为的接受和承诺疗法（ACT）治疗（CBT）用于共存的抑郁/焦虑症（目前），并通过高清期间的远程医疗。未分配给OTM或BPM的控制条件通常是护理并可以选择在12个月末接受ACT。我们将检查 OTM（与NO OTM，AIM 1）和BPM（相对于NO BPM，AIM 2）的有效性超过9个月用于减少阿片类药物的使用（主要结果）和改善疼痛严重程度（次要结果）慢性阿片类药物的HD患者。实施目标将利用多元化的优势希望财团的患者，提供商和组织环境评估流程来自多个利益相关者的结果（AIM 3）。我们的研究结合了新颖的工具和减少阿片类药物相关的发病率的资源，解决阿片类药物流行病，减轻痛苦高清患者，除了提供见解以告知这些干预措施中透析实践和政策。