Improving Pain Management and Opioid Safety for Patients With Cirrhosis

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

Detailed Description
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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.

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

Conditions
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Cirrhosis, Liver

Intervention / Treatment
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* Behavioral: Liver Education About Pain (LEAP)
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEAP Intervention Arm<br>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. | Behavioral: Liver Education About Pain (LEAP)<br>* 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.<br>Behavioral: Usual Care<br>* Patients can continue to use other pain management strategies (usual care) in order to mimic real-life conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver diseases, cirrhosis, liver, implementation science, strategies, evaluation, behavioral intervention