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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA048182-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari S Rogal, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
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| Overall Study |
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participants who started the intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | number of participant who completed at least 80% of sessions/Participants who started intervention | Posted | Count of Participants | Participants | post intervention (6 months) |
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6 months after the start of the intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shari Rogal | University of Pittsburgh | 412-360-6177 | rogalss@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2023 | Oct 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Usual Care | Behavioral | Patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Model for End-Stage Liver Disease (MELD) | This is a validated predictor of mortality among people with cirrhosis that is based on lab results and used across clinical care and research studies. THe scale is from 5-40, where a higher score represents worse outcome and more severe disease. | Median | Inter-Quartile Range | units on a scale |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | end of intervention |
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| 0 |
| 30 |
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| 30 |
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