Improving Pain Management and Opioid Safety for Patients with Cirrhosis

改善肝硬化患者的疼痛管理和阿片类药物的安全性

基本信息

批准号：
9891598
负责人：
Shari S Rogal
金额：
$ 18.85万
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：
2020
资助国家：
美国
起止时间：
2020-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9891598
关键词：
Acetaminophen Address Adverse event Affect Alcohol consumption Alcohol or Other Drugs use Alcohols Analgesics Award Behavior Behavior Therapy Behavioral Behavioral Sciences Cessation of life Chronic Kidney Failure Cicatrix Cirrhosis Complex Coupled Data Development Dose Evidence based intervention Evidence based treatment Exercise Foundations Future Gastroenterologist General Population Goals Guidelines Hepatic Encephalopathy Hepatitis C Hepatitis C virus Hospitalization Impaired cognition Intervention Intervention Trial Interview Lead Life Liver Liver Cirrhosis Liver diseases Mediating Medical Mental Health Mental disorders Mentored Patient-Oriented Research Career Development Award Mentors Mentorship National Institute of Drug Abuse Non-Steroidal Anti-Inflammatory Agents Opioid Opioid Analgesics Overdose Pain Pain management Patients Persistent pain Pharmaceutical Preparations Pharmacology Population Positioning Attribute Public Health Randomized Relaxation Research Research Personnel Risk SECTM1 gene Savings Science Structure Substance Use Disorder Symptoms Target Populations Testing Toxic effect Training Transplantation United States United States National Institutes of Health Work addiction base behavioral clinical trial career chronic pain chronic pain management chronic pain patient comorbidity design efficacy trial experience healing high risk high risk population improved innovation interest liver transplantation mortality multidisciplinary non-opioid analgesic opioid epidemic opioid misuse opioid mortality opioid overdose opioid overuse opioid therapy opioid use pain patient pain relief pain self-management patient population patient safety pilot trial prescription opioid primary outcome skills social cognitive theory success theories therapy design treatment as usual

项目摘要

Prescription opioid medications are a leading cause of opioid-related death and are particularly risky in patients with liver cirrhosis. Cirrhosis affects four million people in the US and is most often due to alcohol or substance use disorder (SUD)-mediated hepatitis C. In this population, prescription opioids are associated with decreased access to life-saving transplantation and increased complications of liver disease, hospitalizations, and mortality. Despite these risks, approximately half of all patients with cirrhosis are prescribed opioid medications each year. This is likely because 80% of patients with cirrhosis have chronic pain and alternative pain management strategies have not been designed for or tested in this population. Indeed, existing pain management interventions designed for general populations do not address many of the specific issues facing patients with cirrhosis such as their overall high symptom burden, contraindications to most common analgesic medications, and underlying mental health and SUDs. The National Pain Strategy recommends using behavioral interventions, specifically pain self-management interventions, to address chronic pain. However, such interventions are most effective when they are designed to address the specific needs of the population of interest. Therefore, the overarching research goal of this K23 award is to develop and test a behavioral intervention for chronic pain for patients with cirrhosis. This goal will be achieved through the following Specific Aims: Aim 1) To develop a theory-based behavioral intervention to improve pain and function for patients with cirrhosis; and Aim 2) To conduct a randomized pilot trial of the intervention developed in Aim 1. Existing pain self-management interventions will serve as a starting point for this work. Following the established steps of Intervention Mapping (IM), a structured approach to developing theory-based behavioral interventions, stakeholder input and semi-structured interviews will be integrated into a behavioral intervention for pain that addresses the needs of patients with cirrhosis. The resulting intervention will be pilot tested in 40 patients with cirrhosis and chronic pain. This research is significant because it aims to address the national opioid crisis in a high-risk, understudied population. Furthermore, this approach may be applicable to other populations with high rates of chronic pain and SUDs. This research is innovative because it will lead to the first intervention for pain for this population. Dr. Shari Rogal is uniquely positioned to conduct this study, as she is a gastroenterologist and transplant hepatologist with a research focus on studies of SUDs and pain in the context of liver disease. Through this award Dr. Rogal will receive additional training in chronic pain science, behavioral science, and behavioral clinical trials, as well as the support of a multidisciplinary mentoring team. This K23 will thus allow her to develop an independent research career as a leader in developing, testing, and implementing interventions for chronic pain in patients with complex medical, mental health, and substance use comorbidities.

处方阿片类药物是阿片类药物相关死亡的主要原因，对患者来说尤其危险患有肝硬化。肝硬化影响美国四百万人，最常见的原因是酒精或药物使用障碍 (SUD) 介导的丙型肝炎。在该人群中，处方阿片类药物与丙型肝炎的减少有关获得挽救生命的移植以及肝病、住院和住院的并发症增加死亡。尽管存在这些风险，大约一半的肝硬化患者仍服用阿片类药物每年。这可能是因为 80% 的肝硬化患者有慢性疼痛和替代性疼痛尚未针对这一人群设计或测试管理策略。确实，现有的痛苦为一般人群设计的管理干预措施并不能解决面临的许多具体问题肝硬化患者，例如总体症状负担较高、最常见镇痛药的禁忌症药物、潜在的心理健康和 SUD。国家疼痛战略建议使用行为干预，特别是疼痛自我管理干预，以解决慢性疼痛。然而，此类干预措施在旨在满足民众的具体需求时最为有效的兴趣。因此，K23 奖项的总体研究目标是开发和测试行为肝硬化患者慢性疼痛的干预。这一目标将通过以下具体措施来实现目的：目标 1) 开发一种基于理论的行为干预措施，以改善患有以下疾病的患者的疼痛和功能：肝硬化；目标 2) 对目标 1 中开发的干预措施进行随机试点试验。现有疼痛自我管理干预措施将作为这项工作的起点。按照既定步骤干预映射（IM），一种开发基于理论的行为干预的结构化方法，利益相关者的意见和半结构化访谈将被纳入针对疼痛的行为干预中，满足肝硬化患者的需求。由此产生的干预措施将在 40 名患有以下疾病的患者中进行试点测试肝硬化和慢性疼痛。这项研究意义重大，因为它旨在解决国家阿片类药物危机高风险、未充分研究的人群。此外，这种方法可能适用于其他人群慢性疼痛和 SUD 的发病率很高。这项研究具有创新性，因为它将导致首次干预这群人的痛苦。 Shari Rogal 博士具有独特的优势来开展这项研究，因为她是一名胃肠病学家和移植肝病学家，研究重点是 SUD 和疼痛的研究肝脏疾病的背景。通过该奖项，罗加尔博士将接受慢性疼痛科学方面的额外培训，行为科学和行为临床试验，以及多学科指导团队的支持。因此，这个 K23 将使她能够作为开发、测试和应用领域的领导者发展独立的研究生涯。对患有复杂医疗、心理健康和物质的患者实施慢性疼痛干预措施使用合并症。