Project Summary

PCORI has identified opioid use for chronic pain as an important research topic. Patients, clinicians, and others want to learn: How can patients lower their use of opioid medications while managing chronic pain, or eliminate use of these drugs altogether? To help answer this question, PCORI launched a funding initiative in 2016 on Clinical Strategies for Managing and Reducing Long Term Opioid Use for Chronic Pain. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Chronic pain is pain that occurs on at least half the days for six months or more. Chronic pain can make it hard to do everyday activities such as sleeping, walking, working, and spending time with friends and family. Many doctors prescribe opioid medicines to manage chronic pain. But these medicines don’t work as well as other treatments. They also can have serious side effects, and can even cause addiction and death. Patients with chronic pain need treatments that manage their pain, don’t interfere with everyday activities, and don’t have the risks that come with taking opioid pain medicine.

This study is comparing treatment options that may help patients control their pain and take less opioid pain medicine.

Who can this research help?

This research could help people who take opioid medicines for chronic pain, their families and caregivers, and their doctors make choices about how to manage pain and take less opioid pain medicine.

What is the research team doing?

Researchers are recruiting patients who go to Veterans Affairs healthcare facilities for care and who have pain even though they use opioid pain medicine. Researchers are assigning patients by chance to one of two groups. In both groups, patients and their primary care teams are working together to treat pain.

In the first group, a pharmacist care manager works with patients and primary care providers to find effective pain medicine options. The pharmacist provides extra support with regular follow-up phone calls with the patient. In the second group, a medical provider and a mental health provider work with patients to help them set and meet personal health goals. A team of pain clinicians helps find options to treat pain. The team follows up with regular phone calls to help patients meet their goals. Patients may also have face-to-face visits with the clinicians, depending on their needs. In both groups, patients get pain care that’s tailored to their needs and coordinated with primary care.

All patients in the study get information about opioid medicines. Patients who want to take less opioid medicine get support and help to reduce their dose. Patients who are taking very high doses of opioid medicine may be selected by chance to switch to a different opioid medicine, called buprenorphine.

Researchers are looking at whether patients in the first or second group have less pain and take less opioid pain medicine. Researchers also are comparing other outcomes that are important to patients. These include quality of life, sleep, fatigue, depression, anxiety, and medication side effects. Researchers also are looking at why certain people respond better to treatment in one group or the other. They also want to know what patients and their healthcare providers think about the experience.

Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Veterans Affairs patients with chronic pain who take opioid medicine 
Interventions/
Comparators
  • Pharmacist care and individualized pain medicine
  • Integrated pain care and individualized pain treatment
  • Option of switching to buprenorphine (for patients treated with a high daily dose of opioid medicine who are selected by chance)
Outcomes

Primary: pain and interference with activity

Secondary: dosage of opioid pain medicine, quality of life, sleep, fatigue, depression, anxiety, side effects, patient and provider experiences

Timeframe 12-month follow-up for primary outcome

Project Information

Erin Krebs, MD, MPH
University of Minnesota Twin Cities
$12,147,779
Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans

Key Dates

July 2016
November 2023
2016

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022