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临床试验/NCT03743402
NCT03743402已完成不适用

Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering

University of Washington2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2019年4月4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
153
试验地点
2
主要终点
Daily Opioid Morphine Milligram Equivalents (MME)

研究概览

简要总结

In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.

详细描述

In a National Institute on Drug Abuse-funded R34 pilot study of pain self-management training for prescription opioid taper support, it was demonstrated that 22 weeks of opioid taper support promotes opioid dose reduction more effectively than usual care (43% vs 19% dose reduction from baseline) with no increase in pain intensity and significantly reduced activity interference. This intervention will now be adapted and tested in a large integrated primary care system. To address patients' fears of opioid taper that limited recruitment into this pilot study, subjects will be randomized to pain self-management training and then offered the option of self-paced opioid taper. Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on moderate-high dose (≥ 40mg morphine equivalent dose) long-term opioid therapy (LtOT) in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider. Specific Aim 1: To adapt a previously developed prescription opioid taper support intervention into a telephone-delivered pain self-management training that provides the option for supported opioid taper. This will be delivered in multiple primary care clinics by a nurse interventionist trained and supervised by a pain psychologist and will include guidance in opioid and non-opioid medication prescribing. Specific Aim 2: To test in a randomized trial the effects of this intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (questionnaire and electronic health record text indicators), and patient-reported opioid difficulties; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and anxiety and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower opioid doses, greater percent reduction of opioid dose, lower proportions with problem opioid use, lower opioid craving, and lower levels of patient-reported opioid-related difficulties at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, higher global impression of change, and lower levels of anxiety and depressive symptoms at 6 and 12 months after randomization. The proposed trial will determine whether pain self-management training can promote prescription opioid taper in moderate-higher-dose long-term opioid therapy patients without increasing pain level or activity and enjoyment interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessment will be conducted by Kaiser survey team which will be blind to treatment assignment.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-80 years
  • receiving care at a Kaiser Washington primary care clinic;
  • Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months;
  • currently on higher-dose long-term opioid therapy, defined as >90 days' supply in the past 180 days with a mean daily dose of 40 mg MED or greater in the past 90 days, as first identified via Kaiser's pharmacy dispensing data and subsequently validated by patient self-report during screening for the trial
  • consent to participate in the study arm to which they are randomly assigned
  • able to read, speak, and write English adequate for outcome measures
  • enrollment in Kaiser for at least 6 months prior and no plans to disenroll over the next year.

排除标准

  • receiving treatment for cancer
  • enrollment in palliative or hospice care
  • use in past year of parenteral, transdermal, or transmucosal opioids
  • residing in nursing home or assisted living
  • using any implanted device for pain control
  • psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year
  • current suicidal ideation with plan or intent
  • dementia diagnosis in Electronic Health Record
  • Patients on buprenorphine for any reason, or methadone or naltrexone for treatment of Opioid Use Disorder

结局指标

主要结局

Daily Opioid Morphine Milligram Equivalents (MME)

时间窗: 12 months after randomization

Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).

Pain, Enjoyment of Life, and General Activity (PEG) Score

时间窗: 12 months after randomization

A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.

次要结局

  • Patient Health Questionnaire-8 (PHQ-8) Score(12 months after randomization)
  • Prescription Opioid Misuse Index (POMI) Score(12 months after randomization)
  • Daily Opioid Morphine Milligram Equivalents (MME)(6 months after randomization)
  • Pain Self-Efficacy Questionnaire (PSEQ) Score(12 months after randomization)
  • Prescription Opioid Difficulties Scale (PODS) Score(12 months after randomization)
  • Generalized Anxiety Disorders-7 (GAD-7) Score(12 months after randomization)
  • Patient Global Impression of Change (PGIC) Score(12 months after randomization)
  • Opioid Craving Score(12 months after randomization)
  • Pain, Enjoyment of Life, and General Activity (PEG) Score(6 months after randomization)
  • At Least 30% Reduction in Daily Opioid Dose(12 months after randomization)

研究者

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

Mark Sullivan

Professor of Psychiatry and Behavioral Sciences

University of Washington

研究点 (2)

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