Improving Pain Management and Opioid Safety for Patients With Cirrhosis
Improving Pain Management and Opioid Safety for Patients With Cirrhosis: Pilot Program
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LEAP Intervention Arm
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.
|
Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
post intervention (6 months)
|
|
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.
|
end of intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shari S Rogal, MD, MPH, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY21080148
- 1K23DA048182-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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