Trial Summary

Chronic pain affects over 20% of the U.S. adult population and frequently has debilitating effects on quality of life and physical and mental functioning. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes because of pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include non- pharmacologic treatment options. Nurse care management (NCM) has been successfully used to enhance care for individuals with other chronic conditions or at high risk of complications. Using a type 2 hybrid effectiveness-implementation design, we propose to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain. Each health system will identify appropriate health care professionals to be trained as care managers. For the CBT component, care managers will be trained to engage patients in a remotely delivered CBT program. For exercise, we will offer remotely delivered Enhance Fitness, which is an evidence-based, 16-week program that includes aerobic and strength training exercise. In the UG3 phase, we will engage patients, clinicians, and care managers from 2 health systems serving rural patients in a learning collaborative to pilot the NCM model. In addition, we will adapt infrastructure and workflows to implement the intervention program and engage the partnering health systems in developing relationships with community partners and identifying care managers. In the UH3 phase, we will conduct a randomized controlled trial of the adapted NCM model versus usual care in rural dwelling patients with chronic pain. We have recruited 6 health systems from 2 practice-based research networks, the WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) region Practice and Research Network and the Mecklenburg Area Partnership for Primary Care Research in rural North Carolina. Our primary outcome is pain interference as measured by the Pain, Enjoyment of Life and General Activity (PEG) scale. Our secondary outcomes include physical function, sleep, pain catastrophizing, depression, anxiety, treatment satisfaction, substance use disorder, pain medication use/dosage including opioids, and health care utilization. We will explore if disparities exist by examining heterogeneity in treatment effects via subgroup analyses by age, gender, race/ethnicity, and health insurance. We will use the RE-AIM framework to assess implementation outcomes and qualitative interviews conducted with a subset of patients to evaluate experiences with the intervention. If successful, this study will have a transformative effect on chronic pain management in rural areas by expanding access to evidence-based, non-pharmacologic treatments through an innovative NCM model.

NIH Project Information