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临床试验/NCT03303209
NCT03303209已完成不适用

Patient-Centered Opioid Tapering in Outpatients With Chronic Pain and Long-Term Opioid Use

Stanford University0 个研究点目标入组 51 人开始时间: 2015年9月15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
51
主要终点
Change in Morphine Equivalent Daily Dose (MEDD) from baseline to 4 months.

研究概览

简要总结

This is an observational study of a voluntary opioid tapering protocol conducted in community outpatients taking long term prescription opioids for chronic pain. Patients who would otherwise continue with their existing opioid prescriptions were encouraged to participate in a voluntary opioid taper program. Interested patients were identified by their pain physician, Dr. Richard Stieg, and then completed an online informed consent document and baseline self-report assessments including types and doses of opioid medications as well as demographic and psychosocial measures, clinical and pain characteristics. Patients were either given or mailed a free copy of a patient book The Opioid-Free Pain Relief Kit, or Less Pain, Fewer Pills: Avoid the dangers of prescription opioids and gain control over chronic pain. Over the following weeks and up to 4 months, Dr. Stieg implemented a slow, individually tailored opioid taper in all patient participants. Follow-up online self-report surveys were completed at 4 months post enrollment. Opioid dose data were confirmed via medical chart review, and doses were converted to a standardized morphine equivalent daily dose (MEDD). Main outcome was change in opioid dose baseline to 4 months. Secondary outcome was change in pain intensity (numeric rating scale, 0-10) baseline to 4 months.

详细描述

Background: Background: An estimated 11 million Americans were prescribed long term opioids in 2014-up to 4 percent of the entire U.S. adult population. Patients with chronic pain taking long term opioids are at higher risk for multiple health problems including more severe pain and addiction, and death from accidental overdose. Opioid related overdoses are now a leading cause of death in the U.S. Multiple national agencies have called for reduced opioid prescriptions.

Lower doses of opioids are safer for patients. Patients who take very high dose opioids for chronic pain (>200 morphine equivalent daily dose; MEDD) are at 3-fold increased risk for accidental overdose death compared to those on low doses (1). However, the primary patient concern about reducing opioids is fear of having increased pain. Indeed, evidence is lacking for how to help real-world patients with chronic pain reduce opioid use while controlling their pain.

Inpatient studies suggest that pain improves with intensive pain rehabilitation and opioid cessation (2). interdisciplinary chronic pain rehabilitation combined with opioid cessation in veterans has been associated with improved indices of psychological and physical function, as well as significantly reduced pain in those who stop opioids during the program (3). However, inpatient and intensive opioid reduction programs are costly and unavailable to most patients. Recently, researchers conducted an outpatient randomized controlled trial comparing an outpatient opioid tapering program to usual care (4). The tapering program consisted of psychiatric consultation, opioid dose tapering, and 18 weekly meetings with a physician assistant to explore motivation for tapering and learn pain self-management skills.

No studies exist to inform best practice on opioid reduction in primary care or outpatient pain clinics. There is a critical gap in knowledge on how to help community-based (primary care and pain clinic) outpatients with chronic pain actively reduce opioids while controlling pain. This project was intended to inform real-world patient care to specifically help patients with chronic pain taking long term moderate-, high-, and super high-dose opioids reduce their daily use and associated risks. The goal is to understand whether a simple, patient-centered opioid taper conducted with limited resources and no interdisciplinary supportive treatments (e.g., psychology services, physical therapy) could effectively reduce opioid dose without increasing pain.

Methods

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Over age 18
  • Chronic pain
  • Chronic daily opioids
  • Wish to reduce opioid dose

排除标准

  • Not able to communicate in English
  • Not able to complete electronic questionnaires
  • No major cognitive impairment
  • Not actively engaged in treatment for substance use disorder

结局指标

主要结局

Change in Morphine Equivalent Daily Dose (MEDD) from baseline to 4 months.

时间窗: 4 months

Pre-post MEDD change was calculated

次要结局

  • Change in Pain Intensity from baseline to 4 months(4 months)

研究者

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

Beth Darnall

Clinical Professor

Stanford University

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Patient-Centered Opioid Tapering Study | 临床试验