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

• 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
• 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

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，对患者尤其危险。 肝硬化肝硬化影响着美国400万人，最常见的原因是酒精或物质 使用障碍（SUD）介导的丙型肝炎。在这一人群中，处方阿片类药物与减少 获得挽救生命的移植和肝病并发症的增加，住院治疗， mortality.尽管存在这些风险，但大约一半的肝硬化患者仍接受阿片类药物治疗。 每年.这很可能是因为80%的肝硬化患者有慢性疼痛和替代性疼痛 尚未为这一群体设计或测试管理战略。事实上，现有的疼痛 为一般人群设计的管理干预措施没有解决面临的许多具体问题， 肝硬化患者，如他们的整体高症状负担，禁忌症，最常见的止痛药 药物，以及潜在的心理健康和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，在这方面， 当这些干预措施旨在满足人口的具体需求时，它们最有效 感兴趣因此，这项K23奖的首要研究目标是开发和测试一种行为 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实现： 目的：目的1）开发一种基于理论的行为干预，以改善患者的疼痛和功能， 目的2）对目的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。按照既定的步骤， 干预绘图（IM），一种开发基于理论的行为干预的结构化方法， 利益相关者的输入和半结构化访谈将被整合到疼痛的行为干预中， 满足了肝硬化患者的需求。由此产生的干预措施将在40名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， 高风险未被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的发生率更高。这项研究是创新的，因为它将导致第一次干预， 为这个民族带来痛苦。Shari Rogal博士是进行这项研究的唯一人选，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， 肝病的背景。通过这个奖项，Rogal博士将接受慢性疼痛科学的额外培训， 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，K23将使她能够发展独立的研究事业，成为开发，测试和 对具有复杂医疗、心理健康和物质障碍的患者实施慢性疼痛干预 使用合并症。