Among the one-third of Americans who suffer from chronic non-cancer pain, those treated with long-term opioid therapy often continue use for months or years. Despite the well-known dangers of long-term reliance, there remains a need for evidence-based strategies to help patients reduce chronic opioid use. A new research project including investigators from Vanderbilt University Medical Center will explore how behavioral health interventions may support patients with chronic non-cancer pain in reducing, and eventually ending, their long-term opioid use.
The INSPIRE trial (Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain), to be conducted by investigators at Vanderbilt, the University of North Carolina and Duke University, will compare two behavioral health approaches for reducing opioid use.
“Some of these patients have been on high doses of opioids for more than 10 years,” said Kristin R. Archer, Ph.D., associate professor of orthopedic surgery and of physical medicine and rehabilitation at Vanderbilt. “There are real consequences if they go off too quickly – including anxiety and depression. We believe behavioral health strategies can work to help them reduce.”
Shared Decision-Making vs. CBT
Participants¹ in the study will be randomly assigned to one of two interventions. The first will be a shared decision-making intervention, delivered by the patient’s primary care provider, rheumatologist or pain medicine provider. The provider and patient will make a mutual decision about how to proceed with treatment, using decision aids from the CDC and other sources. All participating providers will be given the option to become a shared decision-making provider; researchers will offer training in the methodology.
The second intervention combines motivational interviewing (MI) and group cognitive behavioral therapy for chronic pain (CBT-CP). A psychologist will conduct one session of MI before beginning CBT-CP. Both approaches will incorporate guideline-concordant care for managing patients with pain and regarding opioids from AHRQ, CDC and other clinical practice guidelines.
“This is a way to help engage the patient; to find out their motivation for quitting,” said Archer. “We’re not saying, ‘you have to reduce,’ we’re trying to see if they’re interested in reduction. We want to understand what their goals are, their values and beliefs, their fears. It’s a communications strategy; you want the patient talking more than the provider.”
“Reduction without a successful communication strategy or other options for patients can be harmful for the patient-provider relationship.”
Evaluation of Interventions
The study will use real-time randomization to limit participant loss prior to treatment. Researchers will examine opioid dose reduction, physical functioning, and pain scores. Clinical outcomes will be assessed at four time points: baseline, six months, 12 months, and 18 months. Patient-reported outcomes of physical functioning and pain levels will be measured via patient survey at three time points: baseline, six months, and 12 months.
The project team will explore intervention efficacy according to participant characteristics such as age, sex, baseline pain level, baseline opioid dose, physical comorbidities, mental health comorbidities, and a history of substance abuse. Qualitative research methods will help obtain patient input on their experiences of long-term opioid use.
“Before, we were prescribing opioids as a primary management strategy and now we’re trying to reduce; reduction without a successful communication strategy or other options for patients can be harmful to the patient-provider relationship,” Archer said. “Providers who don’t do it right just reduce dosages without education or patient involvement in the decision. We hope to identify an alternative approach that works.”