Trial Outcomes & Findings for Improving Pain Management and Opioid Safety for Patients With Cirrhosis (NCT NCT05128578)
NCT ID: NCT05128578
Last Updated: 2024-12-10
Results Overview
participants who started intervention and completed ≥80% of intervention sessions divided by the number who started intervention (completed a session)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
post intervention (6 months)
Results posted on
2024-12-10
Participant Flow
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.
Participant milestones
| Measure |
LEAP Intervention Arm
Enrolled patients will participate in 12 weekly sessions led by a health coach to learn self-pain management tools and skills. In addition to 6 individual sessions and 6 optional group sessions, participants will complete activities from the LEAP workbook (provided after enrollment), as tracking is a key component of most pain-self management interventions and is intended to address self-regulation. All patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
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.
Usual Care: Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Baseline Survey
|
24
|
|
Overall Study
Received Intervention
|
21
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
LEAP Intervention Arm
Enrolled patients will participate in 12 weekly sessions led by a health coach to learn self-pain management tools and skills. In addition to 6 individual sessions and 6 optional group sessions, participants will complete activities from the LEAP workbook (provided after enrollment), as tracking is a key component of most pain-self management interventions and is intended to address self-regulation. All patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
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.
Usual Care: Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Improving Pain Management and Opioid Safety for Patients With Cirrhosis
Baseline characteristics by cohort
| Measure |
LEAP Intervention Arm
n=21 Participants
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.
|
|---|---|
|
Age, Categorical
Overall · <=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Overall · Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Overall · >=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
Overall
|
57.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
Model for End-Stage Liver Disease (MELD)
|
9 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: post intervention (6 months)Population: number of participant who completed at least 80% of sessions/Participants who started intervention
participants who started intervention and completed ≥80% of intervention sessions divided by the number who started intervention (completed a session)
Outcome measures
| Measure |
LEAP Intervention Arm
n=21 Participants
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.
|
|---|---|
|
Number of Participants Attending ≥80% of Intervention Sessions
Completed 80% of sessions
|
16 Participants
|
|
Number of Participants Attending ≥80% of Intervention Sessions
Did not complete
|
5 Participants
|
PRIMARY outcome
Timeframe: end of interventionPopulation: 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.
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.
Outcome measures
| Measure |
LEAP Intervention Arm
n=12 Participants
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.
|
|---|---|
|
Overall Satisfaction
|
1.56 units on a scale
Standard Deviation .27
|
Adverse Events
LEAP Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place