HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Prior treatment

• Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months

Other illness

• Current opioid use disorder
• Current non-opioid substance use disorder with the exception of tobacco use disorder
• Current use of methadone, buprenorphine, or naltrexone for opioid use disorder
• Cognitive impairment that, in the judgement of the research team, precludes trial participation
• Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder
• 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.

Other

• Current use of heroin
• Current receipt of hospice care
• Active suicidal intent
• Life expectancy \< 6 months
• Current incarceration

• 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