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Phase IV

Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study (VOICE)

  • Study HIC#:2000021555
  • Last Updated:07/15/2021

Brief Summary:

Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.

  • Age21 years and older
  • GenderBoth
  • Start Date12/20/2017
  • End Date10/31/2020

Trial Purpose and Description

The overall objective of this research is to improve effectiveness and safety of pain management among patients with chronic pain. This 12-month pragmatic randomized trial will compare two pain care delivery strategies, which differ substantially in comprehensiveness and resource intensity, to improve pain and reduce opioid use among Veterans. We will also conduct an opioid tapering strategy substudy that will examine comparative effectiveness of tapering with or without the option for buprenorphine rotation in the high-dose subgroup of study participants.

Eligibility Criteria

Inclusion Criteria:

  • Moderate or high-dose long-term opioid therapy (≥ 50 ME mg daily for at least 3 months) for chronic pain
  • Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)

Exclusion Criteria:

  • Dementia diagnosis or moderate-severe cognitive impairment, defined as ≥2 errors on six-item cognitive screener
  • Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
  • Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
  • Documentation of suspected controlled substance diversion
  • Inability to communicate by telephone

Principal Investigator

Sub-Investigators

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