Improving Pain Management and Opioid Safety for Patients With Cirrhosis

NCT05128578 | Completed Results

• 2 other identifiers: STUDY210801481K23DA048182-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis, Liver

Keywords

liver diseases; cirrhosis, liver; implementation science; strategies; evaluation; behavioral intervention

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  end of intervention

Study Arms (1)

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.

Behavioral: Liver Education About Pain (LEAP); Behavioral: Usual Care

Interventions

Liver Education About Pain (LEAP) BEHAVIORAL

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.

LEAP Intervention Arm

Usual Care BEHAVIORAL

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

LEAP Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shari Rogal
• Organization: University of Pittsburgh

rogalss@upmc.edu

412-360-6177

Study Officials

• Shari S Rogal, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 22, 2021
• Study Start: March 14, 2022
• Primary Completion: October 21, 2023
• Study Completion: October 21, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)