Cirrhosis, Liver
Conditions
Keywords
liver diseases, cirrhosis, liver, implementation science, strategies, evaluation, behavioral intervention
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.
Interventions
BEHAVIORALLiver 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.
BEHAVIORALUsual Care
Patients can continue to use other pain management strategies (usual care) in order to mimic real-life conditions.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LEAP Intervention Arm Participants took part in Liver Education About Pain (LEAP), a modular, virtual 12-week pain self-management intervention. The 6 individual sessions and 6 optional group sessions were led by a health coach to help participants learn self-pain management tools and skills. Individual sessions served to tailor the program to the needs of the participants. Group sessions allowed participants to practice skills, set goals with the group, seek social support, and learn together. As part of the intervention, participants also received a manual (LEAP manual) with useful information and activities to help with goal setting and tracking progress.
Participants also continued to use any other pain management strategies (usual care) in order to mimic real-life conditions. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | LEAP Intervention Arm |
|---|---|
| Age, Categorical Overall <=18 years | 0 Participants |
| Age, Categorical Overall >=65 years | 6 Participants |
| Age, Categorical Overall Between 18 and 65 years | 15 Participants |
| Age, Continuous Overall | 57.5 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Model for End-Stage Liver Disease (MELD) | 9 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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)
Population: number of participant who completed at least 80% of sessions/Participants who started intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEAP Intervention Arm | Number of Participants Attending ≥80% of Intervention Sessions | Did not complete | 5 Participants |
| LEAP Intervention Arm | Number of Participants Attending ≥80% of Intervention Sessions | Completed 80% of sessions | 16 Participants |
Primary
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
Population: 12 patients completed this measure at the end of intervention. Note-one patient responded that they did not know about the intervention and was removed from further analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEAP Intervention Arm | Overall Satisfaction | 1.56 units on a scale | Standard Deviation 0.27 |