A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 643
- 试验地点
- 16
- 主要终点
- Pain Interference
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Pain Coping Skills Training
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.
干预措施: Pain Coping Skills Training (PCST) (Behavioral)
Pain Coping Skills Training
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.
干预措施: Buprenorphine (Drug)
Usual Care
Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Pain Interference
时间窗: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.
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.
次要结局
- Rate of Deaths(Through Week 36 follow-up)
- Buprenorphine Acceptability(Through Week 36)
- Pain Intensity(Weeks 12, 24, and 36)
- Pain Catastrophizing(Weeks 12, 24, and 36)
- Opioid Use(Weeks 12, 24, and 36)
- Number of Falls(Throughout the 36-week follow-up)
- Rate of Falls(Though Week 36 follow-up)
- Number of Hospitalizations(Through 36-week follow-up)
- Rate of Hospitalizations(Through Week 36 follow-up)
- Number of Deaths(Through the 36-week follow-up)
- Buprenorphine Tolerability(Through Week 36)
- Overall Sense of Quality of Life(Weeks 12, 24, and 36)
- Physical Functioning(Weeks 12, 24, and 36)
- Depression(Weeks 12, 24, and 36)
- Anxiety(Weeks 12, 24, and 36)
- Coping(Weeks 12, 24, and 36)
- Sleep Quality(Weeks 12, 24, and 36)
- Fatigue(Weeks 12, 24, and 36)
- Satisfaction With Treatment(Weeks 12, 24, and 36)
- Social Support(Weeks 12, 24, and 36)
- Family Intrusion(Weeks 12, 24, and 36)
- Self-Efficacy(Weeks 12, 24, and 36)
- Presence of Other Symptoms(Weeks 12, 24, and 36)
- Severity of Other Symptoms(Week 12, 24, 36)
- Discrimination(Baseline, Week 36)