Improving Pain Management and Opioid Safety for Patients With Cirrhosis

Sponsor

University of Pittsburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT05128578

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

24.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver	Behavioral: Liver Education About Pain (LEAP) Behavioral: Usual Care	N/A

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 alternating group and individual sessions. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. Individual sessions serve the purpose of individualizing the program to the needs of the patients. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The Liver Education About Pain (LEAP) is a modular 12-week pain self-management intervention with alternating group and individual sessions. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. Individual sessions serve the purpose of individualizing the program to the needs of the patients. 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.The Liver Education About Pain (LEAP) is a modular 12-week pain self-management intervention with alternating group and individual sessions. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. Individual sessions serve the purpose of individualizing the program to the needs of the patients. 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)

Masking Description:

Enrolled participants will be randomized to one of two study arms (intervention or usual care) using permuted block randomization at the patient level, stratified by prescription opioid analgesia in the last year. The study statistician will develop the randomization schedule using standard randomization procedures, mimicking the anticipated randomization in the efficacy trial

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 14, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LEAP Intervention Arm Half of the recruited patients (anticipate 20) will participate in 12 weekly sessions to teach self-pain management tools and skills. In addition to alternating weeks of group and individual sessions, participants will track their activities using the LEAP workbook provided during the first meeting, 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) The study 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 alternating group and individual sessions. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. Individual sessions serve the purpose of individualizing the program to the needs of the patients. 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.
Active Comparator: Usual Care Half of the recruited patients (anticipated 20) will receive usual care under the control arm of this study. These participants will not receive the intervention.	Behavioral: Usual Care Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.

Arm

Intervention/Treatment

Experimental: LEAP Intervention Arm

Half of the recruited patients (anticipate 20) will participate in 12 weekly sessions to teach self-pain management tools and skills. In addition to alternating weeks of group and individual sessions, participants will track their activities using the LEAP workbook provided during the first meeting, 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)

The study 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 alternating group and individual sessions. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. Individual sessions serve the purpose of individualizing the program to the needs of the patients. 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.

Active Comparator: Usual Care

Half of the recruited patients (anticipated 20) will receive usual care under the control arm of this study. These participants will not receive the intervention.

Behavioral: Usual Care

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

Outcome Measures

Primary Outcome Measures

Number of participants attending ≥80% of intervention sessions [Approximately 6-12 months start-to-finish]
Attendance will be studied by combining participant completion of follow-up measures and attending ≥80% of intervention sessions.
Overall Satisfaction [Approximately 6-12 months start-to-finish]
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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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