Improving Pain Management and Opioid Safety for Patients With Cirrhosis

Cirrhosis, Liver Clinical Trial

Official title:

Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128578
• Other study ID #: STUDY21080148
• Secondary ID: 1K23DA048182-01A
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: October 21, 2023

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 21, 2023
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Behavioral:
• Liver Education About Pain (LEAP)
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.
• Usual Care
Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants attending =80% of intervention sessions	Attendance will be studied by combining participant completion of follow-up measures and attending =80% of intervention sessions.	Approximately 6-12 months start-to-finish
Primary	Overall Satisfaction	The primary acceptability outcome will be overall satisfaction with the intervention and will be operationalized using the Client Satisfaction Questionniare-8, an 8-item Likert-based general satisfaction measure that sums to a score of 8 to 32. A total score of =24, indicating an average score of "satisfied" across items, in at least 80% of participants will be operationalized as "acceptable."	Approximately 6-12 months start-to-finish