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: 10175007
• 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 2021-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10175007
• 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：阿片类药物治疗慢性疼痛的使用迅速增加。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，目前没有循证治疗可用于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（提高阿片类药物处方的安全性; ISOP）是否提高阿片类药物的安全性，（B）评估分配到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相关程度。 症状研究方法：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对改善阿片类药物安全性的有效性。我们将 随机分配初级保健提供者（PCP）及其相关PACT护士（各n=64）;患者（n=320）将按临床医生状态嵌套。PCP和PACT护士将参加教育研讨会与研讨会加干预。干预护士护理经理将维护登记的患者，跟踪临床进展和通过电子病历提供的护理，跟踪尿液药物检测管理和结果，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，当患者证明处方阿片类药物误用或滥用的证据时，为PCP提供决策支持。决策支持将具体涉及在患者误用或滥用处方阿片类药物时修改治疗的最佳实践，以及与患者就治疗方案和决定进行沟通的最佳实践。护士护理经理还将与入组的参与者单独会面，讨论预防/减少阿片类药物不良反应的策略，防止转移，并提供筛选处方阿片类药物滥用的理由。该干预措施将重点关注减少处方阿片类药物滥用和阿片类药物的不良影响，同时还致力于提高医患关系的质量。对退伍军人医疗保健的预期影响：阿片类药物通常用于患有慢性疼痛的退伍军人。不幸的是，这些药物也与显著的不良反应有关，包括处方阿片类药物误用，滥用和转移。如果这项研究的结果是显着的，这将提供一个务实的干预，以帮助初级保健提供者减少处方阿片类药物滥用和其他不良反应，并提高患者的满意度与护理。

项目成果

A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT).

减少处方阿片类药物滥用的整群随机临床试验：提高阿片类药物治疗 (ISOT) 的安全性。

• DOI: 10.1007/s11606-022-07476-7
• 发表时间: 2022
• 期刊: Journal of general internal medicine
• 影响因子: 5.7
• 作者: Morasco,BenjaminJ;Adams,MelissaH;Hooker,ElizabethR;Maloy,PatriciaE;Krebs,ErinE;Lovejoy,TravisI;Saha,Somnath;Dobscha,StevenK
• 通讯作者: Dobscha,StevenK

Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial.

提高阿片类药物治疗（ISOT）安全性整群随机试验的研究方法和基线结果。

• DOI: 10.1016/j.cct.2020.105957
• 发表时间: 2020
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Morasco,BenjaminJ;Adams,MelissaH;Maloy,PatriciaE;Hooker,ElizabethR;Iacocca,MeganO;Krebs,ErinE;Carr,ThomasP;Lovejoy,TravisI;Saha,Somnath;Dobscha,StevenK
• 通讯作者: Dobscha,StevenK

CE: Implementing Guidelines for Treating Chronic Pain with Prescription Opioids.

CE：使用处方阿片类药物治疗慢性疼痛的实施指南。

• DOI: 10.1097/01.naj.0000605344.99391.78
• 发表时间: 2019
• 期刊: The American journal of nursing
• 作者: Maloy,PatriciaE;Iacocca,MeganO;Morasco,BenjaminJ
• 通讯作者: Morasco,BenjaminJ