Clinical trial NCT05128578: Improving Pain Management and Opioid Safety for Patients With Cirrhosis
Official title: Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: liver diseases
cirrhosis, liver
implementation science
strategies
evaluation
behavioral intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: LEAP is a modular 12-week pain self-management intervention with 6 individual sessions and 6 optional 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All participants must be over 18 years of age and fluent in English
* Must have a diagnosis of cirrhosis
* Must be receiving care at UPMC hepatology clinics
* Must have chronic pain lasting at least 3 months

Exclusion Criteria:

* Participants will be excluded if they are younger than 18 years of age or are unable to provide informed consent for any reason
* Participants will be excluded if they had a prior liver transplantation or have a limited life expectancy of less than 6 months

Primary outcomes:
measure: Number of Participants Attending ≥80% of Intervention Sessions
timeFrame: post intervention (6 months)
measure: Overall Satisfaction
timeFrame: end of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Shari S Rogal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: