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  1. Safe Use Initiative

Nurse Pain Educator Pilot Program

Performer: NEMA Research, Inc.

Principal Investigator: Joseph V. Pergolizzi Jr., M.D.

Project Duration: 9/22/14 - 9/21/17

Regulatory Science Challenge

Chronic pain, for which opioids are a common treatment, affects approximately 50 million American adults. In recent years, the nation has also witnessed major public health issues arising from opioid abuse, misuse, and diversion. A key effort to address these issues is the effective education of physicians and patients, to help ensure that opioids are properly prescribed and used. In its 2009 Safe Use Initiative report, FDA proposed that more education of patients, pharmacists, and clinicians could reduce unintentional exposure to opioids.

Project Description

NEMA Research conducted a pilot study to examine the impact of a Nurse Pain Educator on fostering the safe and appropriate use of opioids. By modifying the nurse-educator model, the Nurse Pain Educator could become a pivotal figure in the education and management of chronic pain patients who may be prescribed opioids. The study took place at multiple centers, at some of which a Nurse Pain Educator was incorporated into clinics where chronic pain patients are treated with opioids. Patients who were either opioid-naïve or opioid-experienced were enrolled and assessed for six months. The primary endpoint was the difference in total opioid consumption between those patients exposed to a Nurse Pain Educator and those provided usual care (not exposed to a Nurse Pain Educator) during the study period. Total opioid consumption was measured on a monthly basis.

Project Goals

  • Set up and design a Nurse Pain Educator Program, including patient training/assessment materials
  • Implement the Nurse Pain Educator Program at multiple clinical sites that serve patients who are treated for chronic pain
  • Determine if a Nurse Pain Educator can teach patients the safe and appropriate use of opioids
  • Evaluate the effect of a Nurse Pain Educator on consumption of opioids in patients with chronic pain

Project Results

The final report from the researchers to the FDA included the following results:

  • A total of 183 (out of a planned 200) subjects were enrolled and consented. 
  • The patient group exposed to Nurse Pain Educators manifested decreased opioid consumption as measured by average milligram morphine equivalents over the six-month study period, whereas the control patient group (not exposed to a Nurse Pain Educator) manifested an increase opioid consumption. The observed difference between the two patient groups, however, was not statistically significant (p = 0.31).
  • Differences between the two patient groups regarding variables examined through patient surveys (e.g., beliefs, attitudes, and perception regarding opioid use and pain management, current opioid misuse measure, and quality of life) were not statistically significant.
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