Cirrhosis, LiverNCT05128578
Improving Pain Management and Opioid Safety for Patients With Cirrhosis
A study testing Liver Education About Pain (LEAP) in people with Cirrhosis, Liver, run by University of Pittsburgh at 1 site in United States.
Trial summary
This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Liver Education About Pain (LEAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 21 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program
This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.
Read the 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.
- Conditions
- Cirrhosis, Liver
- Being tested
- Liver Education About Pain (LEAP), Usual Care
- Keywords
- liver diseases, cirrhosis, liver, implementation science, strategies, evaluation, behavioral intervention
- Medical subject headings
- Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Education About Pain (LEAP)Behavioural
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.
Usual CareBehavioural
Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
| Study group | Role | What they receive |
|---|---|---|
| LEAP Intervention Arm | Experimental | 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. Receives: Behavioral: Liver Education About Pain (LEAP); Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start14 Mar 2022
- Primary completion21 Oct 2023
- Study completion21 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Shari Rogal, University of Pittsburgh
- Investigators
- Shari S Rogal, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128578
- Sponsor's protocol ID
- STUDY21080148
- Other IDs
- 1K23DA048182-01A1
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2021
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program
- ClinicalTrials.gov ID
- NCT05128578
- Acronym / sponsor ID
- STUDY21080148
- Conditions
- Cirrhosis, Liver
- Keywords
- liver diseases, cirrhosis, liver, implementation science, strategies, evaluation, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 21 Oct 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| LEAP Intervention Arm | Experimental | Behavioral: Liver Education About Pain (LEAP), Behavioral: Usual CareEnrolled 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver 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. | Behavioural | LEAP Intervention Arm |
| Usual CarePatients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions. | Behavioural | LEAP Intervention Arm |
Primary outcome
Number of Participants Attending ≥80% of Intervention Sessions
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari S Rogal, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Education About Pain (LEAP) in people with Cirrhosis, Liver, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Attending ≥80% of Intervention Sessions (time frame: post intervention (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.