U.S. Department of Health & Human Services
Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)
Research Spotlights
Overview
The Research Need
Nearly half of people who have opioid use disorder also experience chronic pain, often without adequate treatment for either. In addition, approximately 13 million Americans with chronic pain continue to be prescribed opioids long-term. For a subset of patients, opioid risks outweigh therapeutic benefit. These individuals may not meet criteria for opioid use disorder but struggle with physical and psychological dependence. Although evidence-based interventions exist for both the treatment of pain and opioid use disorder, less is known about effective strategies to treat people who have both. Systems providing care for these populations are often fragmented and experience limited resources, expertise, and communication.
About the Programs
The Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) program supports a network of multidisciplinary team science collaborations to address the needs of people with pain and a substance use disorder. This research develops and tests combined interventions such as psychotherapy, medications for opioid use disorder, exercise, and pain self-management – embedded within specific health care system settings and with a holistic, whole-patient focus. This research also examines implementation barriers such as cost.
The Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) program supports research to reduce harm and improve the quality of life of people with chronic pain who take opioids long-term. This research develops interventions for patients as well as strategies for health care providers and health systems who help manage the care of these patients. In addition, this program creates resources for research and clinical practice, including a clinical definition for individuals taking opioids long-term for whom opioid risks outweigh benefits.
Program Details
To date, through the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH has awarded $53 million to fund these two initiatives. All projects are co-led by collaborative teams of experienced and early stage investigators from diverse backgrounds, in partnership with people with lived experience and public/private partners (e.g., payors, caretakers, health care providers from multiple disciplines, policymakers, advocacy groups, or professional organizations).
Research Examples
Research examples supported by this program include:
- Evaluating the effectiveness of buprenorphine microdosing and flexible dosing to treat co-occurring chronic pain and opioid use disorder
- Determining the effectiveness of collaborative care, care management, and stepped care approaches for sustaining treatment for chronic pain and opioid use disorder
- Combining pain-targeted psychotherapy or exercise with medications for opioid use disorder
- Developing a composite screening tool for chronic pain and opioid use disorder
- Identifying flexible, safe, and patient-centered schedules and strategies to slowly reduce opioid doses, alone or in combination with other pharmacologic and nonpharmacologic therapies
- Creating a risk-benefit decision tool to assist providers in determining when opioids should be continued, tapered, or tapered and discontinued
- Creating and validating a clinical definition for individuals taking opioids long-term for whom opioid risks outweigh benefits (name, associated behaviors and symptoms, and a screening assessment)
Common Data Elements (CDEs)
All of the trials funded under this initiative are collecting harmonized common data elements (CDEs). CDEs are defined fields describing the data to be collected (e.g., identifying specific variables) along with how to gather the data (e.g., patient-reported outcomes, or PROs), and how the response is represented in a dataset (e.g., allowable responses or variable coding). CDEs are structured as indivisible units of data. This can be either an individual field (e.g., sex) or multiple fields taken together (e.g., the composite score of a scale). A CDE can be used in multiple clinical studies, with content standards that can be applied to different data collection models that are dynamic and may evolve over time. CDEs enable interoperability among data systems.
With input from our partners with lived experience, public/private partners, and research experts from each of the awarded centers, the IMPOWR network developed a comprehensive list of patient-reported outcomes to capture whole recovery. The required CDEs integrates the HEAL CDEs for chronic pain. Since this initiative is intended to address both chronic pain and opioid misuse/OUD, this population may hold particular interest for the broader HEAL research community. As a resource, the IMPOWR CDEs are publicly available to enable meta-data and secondary data analysis. The database of CDEs and associated case-report forms (questionnaires) are available upon request. Please contact Laura Wandner, Ph.D., in the Office of Pain Policy and Planning at the National Institute of Neurological Disorders and Stroke, for more information.
| Domain | CDE |
|---|---|
| Demographics |
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| Chronic Pain |
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| Quality of Life (PROMIS PROPr) |
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| Substance Use |
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| PTSD/Trauma |
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| General Anxiety Disorder |
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| Major Depressive Disorder |
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| COVID/COVID impact |
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| Discrimination/Stigma |
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| Social Determinants of Health |
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| Cost-effectiveness analyses |
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| Implementation Outcomes: Patient-facing |
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| Implementation Outcomes: Provider-facing |
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