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临床试验/NCT05128578
NCT05128578已完成不适用

Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Number of Participants Attending ≥80% of Intervention Sessions

研究概览

简要总结

This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.

详细描述

Prescription opioid medications are a leading cause of opioid-related death and are particularly risky in patients with cirrhosis of the liver, which affects 4 million people in the US. In this population, prescription opioids are associated with complications of liver disease, decreased access to life-saving transplantation, and increased hospitalization, post-transplant mortality, and all-cause mortality. Moreover, most patients with cirrhosis have underlying alcohol and/or substance use disorders (SUDs), which increase the risk of opioid-related complications and misuse. Despite these risks, our pilot work found that nearly half of all patients with cirrhosis are prescribed opioid medications each year and that these prescriptions are often inconsistent with opioid prescribing safety guidelines. One potential reason for this may be the lack of safe, evidence-based, alternative pain management strategies for this patient population. Indeed, existing opioid safety and pain management interventions designed for general populations do not address many of the specific issues facing patients with cirrhosis.

The research team plans to recruit patients at UPMC for participation in the Liver Education About Pain (LEAP) intervention program. LEAP is a modular 12-week pain self-management intervention with individual and group sessions. Individual sessions serve the purpose of individualizing the program to the needs of the patients. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. The purpose of the LEAP program is to make pain better, help patients reach their personal goals (things that may be hard to do because of pain), and add to the care patients' medical team is providing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants must be over 18 years of age and fluent in English
  • Must have a diagnosis of cirrhosis
  • Must be receiving care at UPMC hepatology clinics
  • Must have chronic pain lasting at least 3 months

排除标准

  • Participants will be excluded if they are younger than 18 years of age or are unable to provide informed consent for any reason
  • Participants will be excluded if they had a prior liver transplantation or have a limited life expectancy of less than 6 months

结局指标

主要结局

Number of Participants Attending ≥80% of Intervention Sessions

时间窗: post intervention (6 months)

participants who started intervention and completed ≥80% of intervention sessions divided by the number who started intervention (completed a session)

Overall Satisfaction

时间窗: end of intervention

Treatment expectations questionnaire (TEQ) was used to assess patient satisfaction. This is a 5-item, validated questionnaire includes Likert scale items on a 5-point scale from negative to positive views of different aspects of the intervention (-2 is highly negative views to +2 is highly positive views of the intervention). There is an option for I don't know. Primary outcome was measured using a mean of the mean scores on this Likert scale, where 1 is a somewhat positive view of the intervention and +2 is a highly positive view of the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shari Rogal

Assistant Professor

University of Pittsburgh

研究点 (2)

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