The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.
The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.
复制标题
HOPE 联盟试验的设计和基线特征，旨在减少血液透析中的疼痛和阿片类药物的使用。
DOI：
10.1016/j.cct.2023.107409
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发表时间：
2024
影响因子：
2.2
通讯作者：
Kalim,
中科院分区：
文献类型：
--
作者：
Dember,LauraM;Hsu,JesseY;Bernardo,Leah;Cavanaugh,KerriL;Charytan,DavidM;Crowley,SusanT;Cukor,Daniel;Doorenbos,ArdithZ;Edwards,DavidA;Esserman,Denise;Fischer,MichaelJ;Jhamb,Manisha;Joffe,Steven;Johansen,KirstenL;Kalim,
减少血液透析中疼痛和阿片类药物使用的HOPE联盟试验（HOPE试验）是一项多中心随机试验，旨在解决因终末期肾病接受维持性血液透析的患者的慢性疼痛。该试验采用序贯、多重分配设计，所有受试者（1期）采用随机分组，部分受试者（2期）采用非随机分组。在第1阶段，参与者被随机分配到疼痛应对技能培训（PCST），这是一种旨在提高管理疼痛的自我效能的干预措施，或家庭护理。PCST包括每周一次的、现场的、教练主导的认知行为治疗课程，通过视频或电话会议提供，持续12周，然后是每天通过电话提供的交互式语音应答课程，持续12周。在第24周（第2阶段），PCST组和精神护理组中以平均剂量≥20吗啡毫克当量/天服用处方阿片类药物的受试者均接受丁丙诺啡，丁丙诺啡是一种部分阿片类激动剂，其安全性特征优于完全激动剂阿片类药物。所有参与者都被跟踪了36周。主要结局是在12周时确定的疼痛干扰，用于主要分析。次要结局包括额外的患者报告指标和临床结局，包括福尔斯、住院和死亡。探索性结局包括丁丙诺啡的可接受性、耐受性和疗效。在试验开始后27个月达到了640例受试者的入组目标。该试验的结果将为慢性疼痛的管理提供信息，慢性疼痛是接受维持性血液透析治疗的患者常见且具有挑战性的问题。NCT04571619
The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619