STOP Escalating - Stabilizing Treatment with Opioids for Pain: Comparison of Education and Treatment in Primary Care for Patients with Chronic Pain

This study will address the following PCORI priority question: Among patients with chronic noncancer pain on long-term opioid therapy, what is the comparative effectiveness of strategies for reducing or stabilizing opioid dosage while managing pain? In a pragmatic cluster randomized control trial, we will determine the effectiveness of current pain management plus patient education intervention compared to a patient education plus non-opioid adjuvant medication intervention in primary care settings to improve patient-reported outcomes and stabilize or reduce levels of long-term opioid medication use among patients with chronic pain.  High opioid doses have continued despite limited evidence demonstrating long-term benefit and evidence that prescription opioids may be associated with harm, including accidental overdose, abuse, addiction, diversion, overdose, and accidents including trauma. Many patients with chronic pain conditions begin on low dose opioid therapy and escalate beyond the FDA defined opioid tolerant dose of 60 mg of oral morphine equivalents daily (MED) and high dose therapy of 100mg MED. Although, the risks of harm appear to be dose-dependent with escalating doses resulting in higher risk of morbidity and mortality, patients commonly request these medications from their providers believing that there is no other effective treatment option and there is no substantial harm. Evidence suggests that patients begun on opioid therapy request dose increases over time however studies employing liberal dose escalation strategies in which at each dose increase request by a patient was satisfied did not find substantial improvement in self-reported pain and no difference in function despite significant dose escalation. Patients retrospectively report that the they received insufficient education on the health risks of opioid therapy to make an informed decision and have two core beliefs.  These beliefs – 1) there is no other effective option and 2) opioids are “safer” and have fewer or less detrimental side effects than non-opioid adjuvants – may exist because of lack of patient and provider education.  Engaging primary care physicians and offering minimally invasive educational resources may result in the promise of a more informed decision making process and thereby improved patient safety and the reduction in patients receiving high dose opioid centered pain care.

Other Information:

• Principal Investigator: Robert Hurley, MD, PhD; Medical College of Wisconsin
• PCORI Trial Website

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