Evidence-based strategies to help patients who have been using opioids for chronic, non-cancer pain are in short supply. Now, though, a large research project is comparing the effectiveness of two behavioral health interventions designed to help such patients cut down on and ultimately stop using opioids.
The INSPIRE trial, is being conducted by investigators at Vanderbilt University Medical Center, the University of North Carolina and Duke University.
“Some of these patients have been on high doses of opioids for more than 10 years,” said Kristin R. Archer, Ph.D., professor of orthopaedic 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.”
Adjusting the Study to Improved Prescribing Practices
Study participants are randomly assigned to one of the two interventions. Participants must be ages 18 to 85 years, have chronic non-cancer pain, and be receiving high-dose chronic opioid therapy as evidenced by a current or most recent prescription for a minimum average daily morphine-equivalent dose of 20 milligrams or greater.
Originally, the researchers had sought patients taking an average dose of 40 milligrams or greater, but that proved impractical.
“It’s gotten harder to find people on a dose of 40 milligrams; we’re prescribing less now, and that’s a good thing,” Archer said. At all three institutions involved in the trial, opioid dosages have been declining, she added.
Shared Decision-Making vs. CBT
The first intervention revolves around shared decision-making and will be delivered by the patient’s primary care provider, rheumatologist or pain medicine provider. The provider and patient will make a mutual decision about 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.
“From the patients’ perspective, they like telehealth better.”
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 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 their goals, values, beliefs and fears. It’s a communications strategy; you want the patient talking more than the provider.”
Adapting the Study to Address COVID-19
The researchers originally planned to stop enrolling patients by March 2021, but delays caused by COVID-19 have meant that enrollment will continue through March 2022. “We will then take another year to follow the patients. We expect the study to be complete and to publish in March 2023,” Archer said.
Also, both interventions were planned to be administered through face-to-face interactions.
“We were doing everything in person before, but with COVID, we had to switch to telehealth in the middle of the study,” Archer said.
Physicians can now meet online with patients for the shared decision-making intervention, and the CBT intervention also takes place virtually.
“Reduction without a successful communication strategy or other options for patients can be harmful to the patient-provider relationship.”
The researchers will do a secondary analysis to compare the benefits of telehealth treatments with those delivered in person.
“From the patients’ perspective, they like telehealth better,” Archer said, noting that previously many patients in the study had to drive long distances to participate.
Evaluation of Interventions
The researchers will examine opioid-dose reduction, physical functioning and pain scores. Clinical outcomes will be assessed four times: at baseline, six months, 12 months and 18 months. Patient-reported outcomes of physical functioning and pain levels will be measured via patient survey three times: at 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 substance abuse history. 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.”