HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Study Overview
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Brief Summary
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HOPE is a randomized clinical trial that will evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease. The hypothesis is that pain coping skills training will be effective at reducing pain and opioid use, and that buprenorphine will be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population.

Official Title
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A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis

Conditions
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End Stage Renal Disease, Chronic Pain, Opioid Dependence

Intervention / Treatment
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* Behavioral: Pain Coping Skills Training (PCST)
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Undergoing in-center maintenance hemodialysis for ≥90 days English- or Spanish-speaking Chronic pain defined as a response of Most days or Every day to the following question: In the past 3 months, how often have you had pain? Answer options: Never, Some days, Most days, Every day Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4 Willing to provide informed consent Willing to allow research team to obtain opioid pharmacy refill data Willing to allow research team to contact and work with their opioid prescriber Exclusion Criteria: Current opioid use disorder Current use of heroin Current non-opioid substance use disorder with the exception of tobacco use disorder Current use of methadone, buprenorphine, or naltrexone for opioid use disorder Current receipt of hospice care Cognitive impairment that, in the judgement of the research team, precludes trial participation Active suicidal intent Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder Life expectancy < 6 months Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months Current incarceration Any other condition that the investigator considers precludes participation in the clinical trial Subgroup with Current or Recent Opioid Use During eligibility screening all potential participants will have opioid use ascertained using the timeline follow back approach. The trial will enroll at least 300 participants (among the 640 total study participants) with current or recent opioid use defined as patient-reported prescription opioid use during at least 3 of the past 6 months. The number of participants in the opioid use subgroup will be monitored throughout the trial enrollment period. If the rate of enrollment into the opioid use subgroup is lower than targeted, trial enrollment will be restricted to individuals meeting the opioid use criteria as long as necessary to ensure that the total enrollment target for the trial is not met without reaching the opioid use subgroup target.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sequential multiple assignment design with a randomized component followed by a non-randomized component
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pain Coping Skills Training<br> | Behavioral: Pain Coping Skills Training (PCST)<br>* The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.<br>|
| No Intervention: Usual Care<br> | |
| Active Comparator: Buprenorphine<br> | Drug: Buprenorphine<br>* At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.<br>|
| No Intervention: No Buprenorphine<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain interference | Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse. | The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse. | Weeks 12, 24, and 36 | 
| Pain catastrophizing | Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse. | Weeks 12, 24, and 36 | 
| Opioid use |  | Weeks 12, 24, and 36 | 
| Rate of falls | Event rate; # per patient year | Throughout the 36-week follow-up | 
| Rate of hospitalizations | Event rate; # per patient year | Throughout the 36-week follow-up | 
| Death |  | Throughout the 36-week follow-up | 
| Buprenorphine acceptability | The proportion of participants who initiate buprenorphine from among those randomized to the Buprenorphine group. | Week 36 | 
| Buprenorphine tolerability | The proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance. | Week 36 | 
| Overall Sense of Quality of Life | Quality of life will be measured using the Single-Item QOL Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome. | Weeks 12, 24, and 36 | 
| Physical Functioning | Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Lowest score - 6; Highest score - 30; Higher score equals better outcome. | Weeks 12, 24, and 36 | 
| Depression | Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome. | Weeks 12, 24, and 36 | 
| Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome. | Weeks 12, 24, and 36 | 
| Coping | Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome. | Weeks 12, 24, and 36 | 
| Sleep Quality | Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a and the Sleep Duration Question. PROMIS Sleep Disturbance SF 6a: Lowest score - 6; Highest score - 30; Lower score equals better outcome. Sleep Duration Question: Reported in hours and minutes of sleep; Higher number equals better outcome. | Weeks 12, 24, and 36 | 
| Fatigue | Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Lowest score - 6; Highest score - 30; Lower score equals better outcome. | Weeks 12, 24, and 36 | 
| Satisfaction with Treatment | Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome. | Weeks 12, 24, and 36 | 
| Social Support | Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 7; Highest score - 7; Higher score equals better outcome. | Weeks 12, 24, and 36 | 
| Family Intrusion | Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Lowest score - 8; Highest score - 40; Higher score equals better outcome. | Weeks 12, 24, and 36 | 
| Self-Efficacy | Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain. PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome. | Weeks 12, 24, and 36 | 
| Other Symptoms | Other symptoms will be measured using the Dialysis Symptom Index (DSI). Lowest score - 0; Highest score - 150; Lower score equals better outcome. | Weeks 12, 24, and 36 | 
| Discrimination | Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome. | Week 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, pain, opioids, pain coping skills