Kristin Archer, PhD, DPT, associate professor and vice chair of Orthopaedics and Rehabilitation, will serve as principal investigator at Vanderbilt University Medical Center (VUMC) for a clinical trial that is examining strategies for reducing opioid use among patients with chronic pain.
The Patient-Centered Outcomes Research Institute (PCORI) recently approved a $9 million award for the five-year study. VUMC will receive $1.7 million for its role. More than 1,000 patients from North Carolina and Tennessee, states with high opioid use rates, will be enrolled in the study.
“This pragmatic trial will provide important information on ways to reduce or eliminate chronic opioid use in those individuals who are not benefiting from opioids or wish to reduce the dose they are taking,” Archer said. “Our primary care physicians will be trained in shared decision making, which will help patients understand their treatment options and the risks and benefits of long-term opioid use. Overall, this study will help increase patients’ confidence in their ability to decrease or discontinue opioids.”
Archer will be working with Gurjeet Birdee, MD, assistant professor of Medicine and co-investigator on the project, to oversee all of the research activities at Vanderbilt primary care clinics. This study will be collaborating with the Mid-South Clinical Data Research Network, which is centered at VUMC and includes Duke University Health System and the University of North Carolina at Chapel Hill.
The multisite study will be led by Lauren McCormack, PhD, vice president of RTI International’s Public Health Research Division. RTI is an independent, nonprofit research institute. The research team will receive input from an advisory panel that includes patients and advocates. “This project will help patients better understand the risks, benefits and uncertainties associated with opioid use, which is needed for informed consent and is critical given the status of the opioid epidemic,” McCormack said.
Nearly one-third of Americans suffer from chronic, non-cancer pain, a condition often treated with opioids. The effectiveness of opioid therapy is unclear and exposes individuals to potential risks, including addiction.
Researchers will compare two interventions to evaluate their effect on opioid dosage, physical functioning and pain-related outcomes.
One intervention involves a shared decision-making process where patients and clinicians make evidence-based decisions together that align with the patients’ preferences and values. This approach requires strong communication between the patient and provider about the risks and benefits of treatment options.
The other intervention uses motivational interviewing as a goal-oriented counseling technique to enhance an individual’s motivation for behavior change. This involves cognitive behavioral therapy in group sessions to foster more positive thoughts, emotions and behaviors to help manage pain.
Both groups will also receive care based on the Centers for Disease Control and Prevention’s new guidelines for treating patients who take opioids.
“This project was selected for PCORI funding for its potential to fill an important gap in our understanding of long-term opioid therapy and to give people living with chronic pain useful information to help them weigh the effectiveness and safety of their care options,” said PCORI executive director Joe Selby, MD, MPH. “We look forward to following the study’s progress and working with RTI International to share the results.”
The study specifically focuses on long-term opioid use for people with chronic pain. There is a shortage of high-quality evidence demonstrating the safety and effectiveness of long-term opioid therapy for the management of chronic pain, and to date, no large-scale studies have assessed strategies for managing and reducing chronic opioid use in real-world clinical settings.
RTI International’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. RTI has an extensive portfolio of research that helps policymakers make informed decisions about the prevention and treatment of opioid-use disorders. To learn more, visit RTI’s Opioid Research webpage.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.
