Improving Pain Management and Opioid Safety for Patients With Cirrhosis

Not Applicable

Completed

Conditions: Cirrhosis, Liver

Interventions: Behavioral: Liver Education About Pain (LEAP)
Behavioral: Usual Care

Registration Number: NCT05128578

Lead Sponsor: University of Pittsburgh

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEAP Intervention Arm	Liver Education About Pain (LEAP)	Enrolled patients will participate in 12 weekly sessions led by a health coach to learn self-pain management tools and skills. In addition to 6 individual sessions and 6 optional group sessions, participants will complete activities from the LEAP workbook (provided after enrollment), as tracking is a key component of most pain-self management interventions and is intended to address self-regulation. All patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
LEAP Intervention Arm	Usual Care	Enrolled patients will participate in 12 weekly sessions led by a health coach to learn self-pain management tools and skills. In addition to 6 individual sessions and 6 optional group sessions, participants will complete activities from the LEAP workbook (provided after enrollment), as tracking is a key component of most pain-self management interventions and is intended to address self-regulation. All patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.

Primary Outcome Measures

Name	Time	Method
Number of Participants Attending ≥80% of Intervention Sessions	post intervention (6 months)	participants who started intervention and completed ≥80% of intervention sessions divided by the number who started intervention (completed a session)
Overall Satisfaction	end of intervention	Treatment expectations questionnaire (TEQ) was used to assess patient satisfaction. This is a 5-item, validated questionnaire includes Likert scale items on a 5-point scale from negative to positive views of different aspects of the intervention (-2 is highly negative views to +2 is highly positive views of the intervention). There is an option for I don't know. Primary outcome was measured using a mean of the mean scores on this Likert scale, where 1 is a somewhat positive view of the intervention and +2 is a highly positive view of the intervention.

Secondary Outcome Measures