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临床试验/NCT04902547
NCT04902547已完成不适用

Evaluation of a Patient-Centred, Multidisciplinary Opioid Tapering Program for Individuals With Chronic Non-Cancer Pain on Long Term Opioid Therapy

University of Manitoba5 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年5月1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
26
试验地点
5
主要终点
Pain level

研究概览

简要总结

Chronic pain management is complex, with healthcare providers historically relying on prescribing opioid medications such as morphine. Although opioids may partially improve pain, there are risks associated with them as well, including pain worsening, side effects, addiction and overdose. It is now understood that the management of chronic pain is more effective when multiple healthcare team members work together and incorporate multiple strategies instead of focusing solely on medications. An example of an effective, non-drug strategy for pain is a service offered by clinical psychologists called "Acceptance and Commitment Therapy" - or ACT - which empowers individuals, to implement alternative ways of thinking about and reacting to pain and its effect on their lives.

Canada has responded to the opioid overdose crisis with new guidelines that encourage physicians and those suffering from chronic pain to aim for lower opioid doses whenever possible, a process often referred to as "tapering." Unsurprisingly, tapering opioids is often difficult for patients to consider, primarily due to misconceptions that it will cause more harm than good.

This project aims to address these misconceptions by developing and offering an all-day educational workshop for patients, co-presented by a healthcare team (clinical psychologists, pharmacists and physicians), to provide in-depth information on opioid related risks and misconceptions, as well as a large component focusing on ACT training. Investigators then want to see if these sessions change individual attitudes towards opioid tapering and if it improves willingness and ability to successfully reduce opioid doses to a safer level.

详细描述

Study Objectives:

  1. To evaluate the impact of a patient-centered, multidisciplinary opioid tapering program on overall opioid consumption in individuals with chronic pain on long-term opioid therapy.
  2. To implement opioid patient education workshops to be used in conjunction with the opioid tapering program and evaluate their preliminary feasibility and overall patient acceptance.

As Canada continues to witness a growing opioid crisis, the role of non-opioid medications and non-pharmacological strategies for pain, including behavioral treatments, is becoming more apparent. There is a great need to develop multidisciplinary clinical programs to assist individuals on long term opioid therapy to safely and effectively taper to safer doses of these potentially harmful medications. The use of nonpharmacological modalities will be integral to this process.

All patients enrolled in this project will be given the opportunity to take part in an informed and targeted multidisciplinary opioid tapering program (MTP). As well, half of the study population will be randomly assigned to also take part in a comprehensive opioid education and chronic pain workshop (Patient Education Workshop; PEW).

Abbreviated Methodology:

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
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

  • CNCP on more than half the days in the previous 6 months
  • use of opioids for more than half the days in the previous 90 days
  • daily morphine equivalent dose equal to or greater than 50 mg
  • age 18 years or older
  • cognitive ability to understand questionnaires and participate in English only education sessions
  • minimum average numerical pain rating of 3/10

排除标准

  • Currently receiving ACT or CBT
  • previous experience with ACT within the past 12 months
  • significant uncontrolled depression with or without suicidal ideation
  • current psychosis
  • known or suspected opioid misuse/abuse based on a score of seven or greater on the Opioid Risk Tool
  • known or suspected opioid diversion based on previous clinician report and/or results of urine drug screen

研究组 & 干预措施

Multidisciplinary Tapering Program Only

Experimental

Patients in this arm will take part in the clinical multidisciplinary opioid tapering program (MTP).

干预措施: Multidisciplinary Tapering Program (Procedure)

Patient Education Workshop & Multidisciplinary Tapering Program

Experimental

As above, though patients in this group will also take part in an opioid education workshop

干预措施: Multidisciplinary Tapering Program (Procedure)

Patient Education Workshop & Multidisciplinary Tapering Program

Experimental

As above, though patients in this group will also take part in an opioid education workshop

干预措施: Patient Education Workshop (PEWs) (Behavioral)

结局指标

主要结局

Pain level

时间窗: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months

Using VAS tool, changes in pain will be evaluated

Opioid use

时间窗: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months

Using morphine equivalent doses, changes in opioid use will be evaluated

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

Dr. Dana Turcotte

Assistant Professor

University of Manitoba

研究点 (5)

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