A Multicenter Study Comparing the Patient Outcomes Associated With Use of a Nurse Pain Educator for Patients With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 8
- 主要终点
- Change Opioid Consumption
研究概览
简要总结
This multicenter randomized (block randomization) controlled parallel arm pilot study comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that treat chronic non cancer pain patients with opioid analgesics. Subjects who are either opioid naïve or opioid experienced will be enrolled into the study.
详细描述
The Nurse Pain Educator arm shall have two phases: a Pre-Teaching Phase and a Teaching/Knowledge Maintenance Phase. During the Pre-Teaching Phase, all subjects who are enrolled will complete different baseline assessments and will be prescribed an opioid. Subjects will then enter the Teaching/Knowledge Maintenance Phase. Subject enrolled into the Nurse Pain Educator arm will be educated on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics. Subjects will meet monthly with the Nurse Educator for up to 5 months for reinforcement of their training and to assess their use of their medication, their quality of life and their physical and mental well-being.
Subjects who are enrolled into the study arm with no Nurse Pain Educator will be monitored every month to assess their use of their medication, their quality of life and their physical and mental well-being. No intervention will be conducted with these subjects beyond that of standard of care at the facility. Subjects will be evaluated monthly but primary differences in outcomes will compare baseline to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to read, understand, and provide written informed consent
- •Male or Female patients ≥ 18 years of age
- •Diagnosed with non-cancer pain for >3 months
- •Ability to meet study requirements (i.e., can attend monthly visits, able to complete questionnaires, etc.)
- •Prescribed an oral opioid that will last duration of the study period
- •Provide a completed Opioid Patient Prescriber Agreement
排除标准
- •Diagnosed with chronic cancer pain
- •Personal or family history of alcohol or drug abuse in the past 5 years
- •Personal or family history of major mental illness
研究组 & 干预措施
No Nurse Education
Subjects who are enrolled into study arm with no Nurse Pain Educator will be monitored every month to assess their use of their medication, quality of life, physical and mental well-being. No intervention will be conducted with these subjects beyond that of standard of care at the facility.
Nurse Education
Subject enrolled into the Nurse Pain Educator arm will be educated (Opioid Education) on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics.
干预措施: Opioid Education (Other)
结局指标
主要结局
Change Opioid Consumption
时间窗: 6 Months
Difference between opioid consumption in subjects with and without education by a Nurse Pain Educator as measured by a Qualitative Assessment of Opioid consumption from change in baseline to end of study and at each month.
Change in Opioid Consumption
时间窗: 6 Months
Difference between opioid consumption in subjects with and without education by a Nurse Pain Educator as measured by Total Morphine Sulfate Equivalent of Prescription from change in baseline to end of study and at each month.
次要结局
- Change in Quality of Life Scale(6 Months)
- Change in Current Opioid Misuse Measure (COMM)(6 Months)
- Change in Pain Medicine Questionnaire (PMQ)(6 Months)
- Change in SF-36(6 Months)