Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

• Status: Active, not recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• Moderate or high-dose long-term opioid therapy (≥ 20 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

• 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