Prescription opioid medications are a leading cause of opioid-related death and are particularly risky in patients with liver cirrhosis. Cirrhosis affects four million people in the US and is most often due to alcohol or substance use disorder (SUD)-mediated hepatitis C. In this population, prescription opioids are associated with decreased access to life-saving transplantation and increased complications of liver disease, hospitalizations, and mortality. Despite these risks, approximately half of all patients with cirrhosis are prescribed opioid medications each year. This is likely because 80% of patients with cirrhosis have chronic pain and alternative pain management strategies have not been designed for or tested in this population. Indeed, existing pain management interventions designed for general populations do not address many of the specific issues facing patients with cirrhosis such as their overall high symptom burden, contraindications to most common analgesic medications, and underlying mental health and SUDs. The National Pain Strategy recommends using behavioral interventions, specifically pain self-management interventions, to address chronic pain. However, such interventions are most effective when they are designed to address the specific needs of the population of interest. Therefore, the overarching research goal of this K23 award is to develop and test a behavioral intervention for chronic pain for patients with cirrhosis. This goal will be achieved through the following Specific Aims:
Aim 1) To develop a theory-based behavioral intervention to improve pain and function for patients with cirrhosis;
and Aim 2) To conduct a randomized pilot trial of the intervention developed in Aim 1. Existing pain self-management interventions will serve as a starting point for this work. Following the established steps of Intervention Mapping (IM), a structured approach to developing theory-based behavioral interventions, stakeholder input and semi-structured interviews will be integrated into a behavioral intervention for pain that addresses the needs of patients with cirrhosis. The resulting intervention will be pilot tested in 40 patients with cirrhosis and chronic pain. This research is significant because it aims to address the national opioid crisis in a high-risk, understudied population. Furthermore, this approach may be applicable to other populations with high rates of chronic pain and SUDs. This research is innovative because it will lead to the first intervention for pain for this population. Dr. Shari Rogal is uniquely positioned to conduct this study, as she is a gastroenterologist and transplant hepatologist with a research focus on studies of SUDs and pain in the context of liver disease. Through this award Dr. Rogal will receive additional training in chronic pain science, behavioral science, and behavioral clinical trials, as well as the support of a multidisciplinary mentoring team. This K23 will thus allow her to develop an independent research career as a leader in developing, testing, and implementing interventions for chronic pain in patients with complex medical, mental health, and substance use comorbidities.
Each year, nearly half of patients with cirrhosis of the liver are prescribed opioid medications for pain, even though these medications are often not effective for treating pain and lead to increased rates of overdose, hospitalization, and death. The proposed project will address this public health problem by developing an intervention to provide non-opioid-based pain management for patients with cirrhosis. Successful completion of this project could lay the foundation for addressing the national opioid crisis in high-risk patient populations.
