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 an initiative in 2016 on Clinical Strategies for Managing and Reducing Long Term Opioid Use for Chronic Pain. The initiative funded this research project and others.

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, or pain that lasts for months or years, is one of the most common health problems. Doctors often treat chronic pain with a type of medicine called opioids. Opioids can help ease pain in the short term. But long-term opioid use can lead to addiction or overdose.

This study compares two ways to help people living with chronic pain to improve their function while managing their pain. The study is looking at how each approach affects opioid use, pain levels, physical and emotional well-being, and satisfaction with pain care.

Who can this research help?

Doctors and patients can use findings from the study when considering ways to treat chronic pain.

What is the research team doing?

The research team is enrolling 1,060 adults ages 18 to 75 who have used opioid medicines for at least 90 days to treat chronic pain. The patients are receiving care at three health systems in North Carolina and Tennessee. The team is assigning patients by chance to one of two treatment groups. Patients in both groups get recommended opioid therapy. In the first group, doctors get training to talk with patients about the benefits, harms, and risks of different treatments and what matters most to the patient. Patients and doctors in this group make decisions about treatment together, based on each patient’s values and preferences. Patients in the second group get eight weekly group sessions and one individual visit with a therapist. These sessions focus on enhancing and supporting patients’ knowledge, beliefs, and skills in managing their pain.

The research team is looking at patients’ electronic health records at the study’s start and again at 6, 12, and 18 months. The team is comparing whether patients in the two groups reduce or stop using opioids. Patients also complete surveys at the study’s start, at 6 months, and at 12 months to answer questions about

  • Ability to do daily activities, such as running errands
  • How pain interferes with their ability to do daily activities
  • Pain level
  • Anxiety and emotional distress
  • Depression symptoms
  • Ability to cope with pain
  • Satisfaction with pain care

The research team is also comparing results among people with different backgrounds or health needs. The team is asking a small number of patients about their experiences with the study through interviews and focus groups.

An advisory committee is working with the team to design and conduct the study. The committee includes patients with chronic non-cancer pain; experts in pain management; and people from patient advocacy organizations, a state government agency, and a health insurer.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Adults ages 18–75 who are taking an average daily dose of opioid medicines of >40 mg morphine equivalent dose for 90 days or more to treat chronic non-cancer pain
Interventions/
Comparators
  • Guideline-concordant opioid therapy plus shared decision making
  • Guideline-concordant opioid therapy plus motivational interviewing and cognitive behavioral therapy
Outcomes

Primary: reduction of opioid use, time to discontinuation of opioid use

Secondary: patient-reported physical functioning and pain interference on physical functioning, intensity of pain, emotional distress, depressive symptoms, ability to cope with pain, satisfaction with pain management

Timeframe 18-month follow-up for primary outcomes

Project Information

Lauren A. McCormack, PhD, MSPH
RTI International
$9,131,857

Key Dates

60 months
October 2017
March 2025
2017

Study Registration Information

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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.

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Last updated: November 15, 2021