Improving Pain Management and Opioid Safety for Patients With Cirrhosis

NCT ID: NCT05128578

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2023-10-21

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.

Conditions

Cirrhosis, Liver

Keywords

liver diseases; cirrhosis, liver; implementation science; strategies; evaluation; behavioral intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

LEAP Intervention Arm

Enrolled patients participated in weekly sessions led by a health coach to learn self-pain management tools and skills. There were 6 individual session and 6 optional group sessions. Participants also received an intervention manual with workbook activities they could complete.

Group Type: EXPERIMENTAL

Liver Education About Pain (LEAP)

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Shari Rogal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shari S Rogal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23DA048182-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21080148

Identifier Type: -

Identifier Source: org_study_id