A Patient-Centered Intervention to Improve Opioid Safety

以患者为中心的干预措施，以提高阿片类药物的安全性

• 批准号: 10172947
• 负责人: Benjamin J. Morasco
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10172947
• 关键词: Absence of pain sensation; Address; Adherence; Adverse effects; Adverse event; Alcohol abuse; Alcohol or Other Drugs use; Cardiovascular system; Care given by nurses; Caring; Case Manager; Chronic; Client satisfaction; Clinical; Clinical Data; Clinical Practice Guideline; Collaborations; Communication; Computerized Medical Record; Data; Educational workshop; Effectiveness; Emergency department visit; Enrollment; Event; Evidence based treatment; Exhibits; Family; Fracture; Friends; Goals; Health; Health Care Costs; Healthcare; Hospitalization; Impairment; Individual; Internist; Intervention; Interview; Medical; Medical Records; Methods; Modification; Monitor; Opioid; Overdose; Pain Clinics; Pain intensity; Pain management; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Primary Health Care; Process; Quality of life; Randomized; Randomized Controlled Trials; Registries; Reporting; Research; Risk; Safety; Specialist; Substance abuse problem; System; Team Nursing; Trust; Uncertainty; Urine; Veterans; Work; adverse outcome; base; care providers; care seeking; chronic pain; chronic pain patient; clinical care; cost effectiveness; depressive symptoms; drug testing; efficacy testing; experience; falls; health care service utilization; improved; mortality; multi-component intervention; nursing intervention; opioid abuse; opioid therapy; patient oriented; prescription monitoring program; prescription opioid; prescription opioid abuse; prescription opioid misuse; prevent; primary care setting; randomized trial; risk mitigation; satisfaction; screening; screening guidelines; therapy design; vehicular accident

 DESCRIPTION (provided by applicant): Background/Rationale: The use of opioid medications to treat chronic pain has rapidly increased. However, opioids are associated with significant harms, including medical adverse effects, misuse, abuse, and diversion. Unfortunately, there are currently no evidence-based treatments available to reduce prescription opioid abuse or other adverse effects in the primary care setting. Objectives: The objectives of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess to what extent assignment to ISOP impacts processes of care, and (c) explore to what extent ISOP is associated with changes in pain intensity, function, quality of life, and depressive symptoms. Methods: To achieve these objectives, we propose a randomized controlled trial to test the efficacy of a multifaceted patient-centered intervention to improve opioid safety. We will randomize primary care providers (PCPs) and their associated PACT nurse (n=64 of each); patients (n=320) will be nested by clinician status. PCPs and PACT nurses will participate in either an educational workshop versus workshop plus intervention. An intervention nurse care manager will maintain a registry of enrolled patients, track clinical progress and care provided through the electronic medical record, track urine drug test administrations and results, monitor state Prescription Drug Monitoring Program data, and collaborate with an internist and substance abuse specialist to provide decision support to PCPs when patients demonstrate evidence of prescription opioid misuse or abuse. Decision support will specifically address best practices for modifying treatment when patients misuse or abuse prescription opioids and for communicating with patients about treatment options and decisions. The nurse care manager will also meet individually with enrolled participants to discuss strategies for preventing/reducin opioid adverse effects, preventing diversion, and providing rationale for screening for prescription opioid abuse. The intervention will focus on reducing prescription opioid abuse and adverse effects of opioids, while also working to improve quality of the clinician-patient relationship. Anticipated Impacts on Veteran's Healthcare: Opioid medications are commonly prescribed for veterans with chronic pain. Unfortunately, these medications are also associated with significant adverse effects, including prescription opioid misuse, abuse, and diversion. If th results from this study are significant, this will provide a pragmatic intervention to assist primay care providers in reducing prescription opioid abuse and other adverse effects, and improving patient's satisfaction with care.

 描述(由申请人提供)： 背景/原理：治疗慢性疼痛的阿片类药物的使用迅速增加。然而，阿片类药物与重大危害有关，包括医疗不良反应、误用、滥用和转移。不幸的是，目前还没有基于证据的治疗方法来减少处方阿片类药物滥用或初级保健环境中的其他不良反应。目的：本研究的目的是：(A)评估多方面干预(提高阿片类药物使用的安全性；ISOP)是否提高阿片类药物的安全性；(B)评估分配给ISOP对护理过程的影响程度；以及(C)探索ISOP与疼痛强度、功能、生活质量和抑郁的变化有关 症状。方法：为了实现这些目标，我们提出了一项随机对照试验，以测试以患者为中心的多方面干预措施提高阿片类药物安全性的有效性。我们会 将初级保健提供者(PCP)及其关联的PACT护士(n=)随机分组；患者(n=320)将按临床医生状况嵌套。PCP和PACT护士将参加教育讲习班或讲习班加干预。干预性护士护理经理将维护登记患者的登记，跟踪临床进展和通过电子医疗记录提供的护理，跟踪尿液药物测试管理和结果，监测国家处方药监测计划数据，并与内科医生和药物滥用专家合作，在患者证明处方阿片类药物滥用或滥用的证据时为PCP提供决策支持。决策支持将具体涉及在患者滥用或滥用处方阿片类药物时修改治疗的最佳做法，以及与患者就治疗选择和决定进行沟通的最佳做法。护士护理经理还将单独会见登记的参与者，讨论预防/减少阿片类药物不良反应的战略，防止转用，并提供筛查处方阿片类药物滥用的理由。干预措施的重点将是减少处方阿片类药物的滥用和阿片类药物的不良影响，同时努力改善临床医患关系的质量。对退伍军人医疗保健的预期影响：患有慢性疼痛的退伍军人通常会开阿片类药物。不幸的是，这些药物也与严重的不良反应有关，包括处方阿片类药物的滥用、滥用和转移。如果这项研究的结果显著，这将提供一种务实的干预措施，帮助初级护理提供者减少处方阿片类药物滥用和其他不良反应，并提高患者对护理的满意度。