Individuals with end stage kidney disease (ESKD) have high prevalence of painful conditions. Common pain medications have poor efficacy and safety profiles due to either the ESKD itself or dialysis treatment. Buprenorphine, a partial opioid agonist has theoretical advantages as a pain medication as its metabolism is in the liver and it is not dialyzed. Although it is approved for pain treatment, it is overwhelmingly prescribed as a treatment for opioid use disorder. Stigma toward opioids and especially medications for substance use disorder may contribute to its being rarely prescribed for pain. Offering to switch from full agonist opioids to buprenorphine is one of the active intervention arms in a HEAL- funded NIDDK-sponsored randomized controlled trial in patients with ESKD and chronic pain, Hemodialysis Opioid Prescription Effort (HOPE). This proposed supplement will augment the main study by examining multilevel barriers, focusing on stigma related to initiation and use of buprenorphine for pain and physical dependence due to prescribed long-term opioid therapy in individuals with ESKD on dialysis.
Aim 1 of the study will inform development of a multi-level stigma intervention to facilitate use of buprenorphine pain medication, when indicated, in patients with ESKD on dialysis through stakeholder interviews with patients, nephrologists, dialysis nurses, primary care physicians, buprenorphine prescribers, dialysis organizations and insurance company executives. We will conduct qualitative interviews with 30 HOPE Trial subjects and their family members (15 who accepted buprenorphine and 15 who did not), and 30 stakeholders including dialysis and primary care clinicians, buprenorphine prescribers, pharmacists, dialysis organization representatives and insurance company executives. A study team including 2 patient-partners will analyze the data using the constant comparative method to inform an intervention targeted at personal, organizational and structural levels.
Aim 2 of the proposal will employ a user design sprint methodology to create a blueprint for a multi- level stigma intervention that would address patients (internalized stigma), clinicians (interpersonal stigma), dialysis organizations (organizational) and insurers (structural) to address barriers to pain treatment with buprenorphine in individuals with ESKD, chronic pain who are physiologically depending on opioids. An exploratory aim of the trial will include a validated measure of stigma for patients enrolled in the parent HOPE trial to be completed beyond the time of the supplement. At study completion, the research team will seek funding to test and disseminate the resulting proposed intervention.
This is a supplement to the Hemodialysis Opioid Prescription Effort (HOPE) consortium, a multi-site trial to improve pain and opioid safety in patients on hemodialysis. This supplement will develop a blueprint for a multi-level intervention to decrease stigma toward buprenorphine prescribing among patients treated with hemodialysis who have chronic pain. It will accomplish this by interviewing patients, clinicians and other key stakeholders (organizations, insurance companies). Investigators will also use a rapid turn- around small group process to incorporate the interview results into a testable intervention.
