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Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program
This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.
Prescription opioid medications are a leading cause of opioid-related death and are particularly risky in patients with cirrhosis of the liver, which affects 4 million people in the US. In this population, prescription opioids are associated with complications of liver disease, decreased access to life-saving transplantation, and increased hospitalization, post-transplant mortality, and all-cause mortality. Moreover, most patients with cirrhosis have underlying alcohol and/or substance use disorders (SUDs), which increase the risk of opioid-related complications and misuse. Despite these risks, our pilot work found that nearly half of all patients with cirrhosis are prescribed opioid medications each year and that these prescriptions are often inconsistent with opioid prescribing safety guidelines. One potential reason for this may be the lack of safe, evidence-based, alternative pain management strategies for this patient population. Indeed, existing opioid safety and pain management interventions designed for general populations do not address many of the specific issues facing patients with cirrhosis. The research team plans to recruit patients at UPMC for participation in the Liver Education About Pain (LEAP) intervention program. LEAP is a modular 12-week pain self-management intervention with individual and group sessions. Individual sessions serve the purpose of individualizing the program to the needs of the patients. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. The purpose of the LEAP program is to make pain better, help patients reach their personal goals (things that may be hard to do because of pain), and add to the care patients' medical team is providing.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Start Date
March 14, 2022
Primary Completion Date
October 21, 2023
Completion Date
October 21, 2023
Last Updated
December 10, 2024
30
ACTUAL participants
Liver Education About Pain (LEAP)
BEHAVIORAL
Usual Care
BEHAVIORAL
Lead Sponsor
University of Pittsburgh
Collaborators
NCT07343037
NCT05982769
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT03208868