An interventional study of Liver Education About Pain (LEAP) and Usual Care in Cirrhosis, Liver, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Liver Education About Pain (LEAP) · Behavioral: Usual Care
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.
Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
Number of Participants Attending ≥80% of Intervention Sessions
participants who started intervention and completed ≥80% of intervention sessions divided by the number who started intervention (completed a session)
Time frame: post intervention (6 months)
Overall Satisfaction
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.
Time frame: end of intervention
Participants were recruited using fliers, mailings followed by calls, in-person clinic recruitment, and Pitt+Me, a service where potential participants can contact researchers for screening. The first participant was enrolled on March 14, 2022, and the last participant was enrolled in March 2023.
| Milestone | LEAP Intervention Arm |
|---|---|
| Started | 30 |
| Baseline survey | 24 |
| Received intervention | 21 |
| Completed | 16 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Lost to follow-up | 5 |
participants who started intervention and completed ≥80% of intervention sessions divided by the number who started intervention (completed a session)
| Participants | LEAP Intervention Arm |
|---|---|
| Completed 80% of sessions | 16 |
| Did not complete | 5 |
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.
| units on a scale | LEAP Intervention Arm |
|---|---|
| Overall Satisfaction | 1.56 ± .27 |
Collected over 6 months after the start of the intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LEAP Intervention Arm | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
participants who started the intervention
| Age, Categorical(Participants) | LEAP Intervention Arm |
|---|---|
| Overall — <=18 years | 0 |
| Overall — Between 18 and 65 years | 15 |
| Overall — >=65 years | 6 |
| Age, Continuous(years) | LEAP Intervention Arm |
|---|---|
| Overall | 57.5 ± 12.4 |
| Sex: Female, Male(Participants) | LEAP Intervention Arm |
|---|---|
| Female | 14 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | LEAP Intervention Arm |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | LEAP Intervention Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | LEAP Intervention Arm |
|---|---|
| United States | 21 |
| Model for End-Stage Liver Disease (MELD)(units on a scale) | LEAP Intervention Arm |
|---|---|
| Median | 9 (7 to 11) |
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