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临床试验/NCT03306147
NCT03306147已完成不适用

Negating Opioid and Pain Actively Through Intervention

Loma Linda University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2017年10月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Decrease in opioid prescription strength

研究概览

简要总结

Chronic pain is one of the most prevalent and debilitating medical conditions and opioid analgesics are a commonly prescribed class of medications in the United States. Opioid efficacy has been proven in terms of managing acute and chronic pain; however, opioid overdose deaths, addictions, and diversions have all continued to increase over the years. The purpose of this study is to increase patient engagement in pain management and education, and to decrease opioid use by 10% over the study period. This study will also help present opportunities for future studies to obtain insight regarding the chronic use of opioids.

详细描述

The institutional review board has approved this prospective single-center study at a large 900-bed academic university medical center. The electronic medical record system will identify 300 patients, who are at least 18 years of age, with a history of opioid use for 3 or more months, or who are currently prescribed and are using long-acting or extended release opioids. Procedures by student pharmacists, pharmacy residents, and pharmacists will include reviewing medical records and prescription drug monitoring programs for the use of opioids, evaluating baseline pain, quality of life, and satisfaction via questionnaires and assessment questions, and performing thorough medication consultations on current opioid regimens. Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician. Opioid usage, pain, quality of life, and patient satisfaction will be assessed. The primary outcome measured will be a decrease in opioid usage in morphine milligram equivalents. Secondary outcomes include change in quality of life and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • at least 18 years of age
  • history of opioid use for 3 or more months or
  • currently prescribed and are using long-acting or extended release opioids

排除标准

  • substance use
  • oncology patients
  • hematology patients

研究组 & 干预措施

Chronic pain or long-acting opioid use

Experimental

Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician.

干预措施: Pain education with follow up encounters (Behavioral)

结局指标

主要结局

Decrease in opioid prescription strength

时间窗: Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date

Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents

次要结局

  • Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale(Change in quality of life score as measured by the PEG pain screening tool by units on a scale between date of subject enrollment and 90 days after subject enrollment date)
  • Reduction in pain as evidenced by decrease in opioid daily dose(Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date)

研究者

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

Huy Le

Medication Safety/Pharmacy Quality Management Coordinator

Loma Linda University

研究点 (2)

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