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Impact

The INSPIRE Trial

Comparing Two Ways to Help Patients Manage Long-Term Pain

Objective

To design a randomized trial to compare two programs for managing chronic pain: (1) shared decision making and (2) cognitive behavioral therapy and motivational interviewing. 

Approach

We monitored opioid dose, pain interference, and physical functioning of patients at three health systems in North Carolina and Tennessee.

Impact

Our work will guide clinicians, researchers, and policymakers as they seek to more effectively manage prescription of opioids and improve treatment of chronic pain. 

Chronic Pain and Opioid Use

Long-term pain —or pain that lasts for months or years—is one of the most common health problems in the United States. About 20% of American adults suffer from long-term pain.

Clinicians often treat long-term pain with opioids. Opioids can help ease pain in the short term, but evidence does not support their effectiveness in the long term. For some people, long-term opioid use can lead to addiction and overdose.

Patients need effective options and different types of support to help improve their function and enjoy life as much as possible. Common strategies include medications and a range of non-pharmacologic options.

The INSPIRE Trial

What is the study about?

INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a study that compared two programs for helping people living with long-term pain to improve their function while managing their pain. People with long-term pain who had been taking opioid medications for three or more months could participate in the study. Cancer patients were excluded from the study.

What was the study design?

Researchers randomly assigned study participants to one of two study programs: (1) Shared Decision Making or (2) Cognitive Behavioral Therapy and Motivational Interviewing.

Shared Decision Making (SDM) Cognitive Behavioral Therapy (CBT) + Motivational Interviewing (MI)
What is it? Patient and provider work together to make decisions that are best for the patient Patient is taught strategies to better cope with chronic pain
What does this look like? Patient has usual pain care visits with a provider trained in SDM Patient has usual pain care visits with their provider; Patient has 8 weekly CBT group sessions with a therapist; Patient has 1 individual MI session
What happens during the visit? Patient and provider discuss patient’s values, concerns, and preferences for managing pain; Patient and provider may discuss slowly reducing or stopping opioid use, if the patient chooses to do so Therapist teaches patients coping skills to increase their ability to function and engage in regular activities; Patient learns how to change the response in the brain that makes pain worse
Tools used Patient packet with decision aids and fact sheets; Treatment options Patient packet with worksheets; At-home exercises

Both programs adhered to clinical guidelines for opioid prescribing.

Throughout the study, INSPIRE researchers partnered with an Advisory Committee that included patients who had lived experience with pain, advocacy organizations, clinicians, and pain experts. The Committee met with researchers regularly to provide feedback on study decisions, recruitment, and materials.

Who were the study participants?

This study was conducted in primary care and pain care clinics where patients were receiving their usual care at three health systems in North Carolina and Tennessee:

  • Duke University Medical Center in Durham, NC
  • University of North Carolina Health System in Chapel Hill, NC
  • Vanderbilt University Medical Center in Nashville, TN

How was the study data collected?

Researchers compared the two programs by looking at changes in opioid dose and physical functioning over time. They collected information on patients’ prescribed opioid dose from patient electronic health records at the beginning of the study and then again at six, twelve, and eighteen months. Participants completed surveys at the beginning of the study and at six and twelve months to answer questions about:

  • Ability to do physical activities, such as running errands and household chores
  • How pain interferes with daily life, such as ability to socialize
  • Current pain level
  • Anxiety and depression symptoms
  • Satisfaction with pain care

What are the study’s next steps?

The recruitment phase of the study is complete and the research team is analyzing data. Results are forthcoming.

We thank the INSPIRE study team collaborators for their contributions. We also thank everyone who enrolled in the study. Research reported here was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (OPD-1610-37006). Disclaimer: The statements presented here are solely the responsibility of the authors and do not necessarily represent the views of PCORI.