A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial.
A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial.
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以患者为中心、护士支持的基于初级保健的协作护理计划，用于治疗阿片类药物使用障碍和抑郁症：MI-CARE 随机对照试验的设计和方案。
DOI：
10.1016/j.cct.2023.107124
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发表时间：
2023
影响因子：
2.2
通讯作者：
Brow
中科院分区：
文献类型：
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作者：
DeBar,LynnL;Bushey,MichaelA;Kroenke,Kurt;Bobb,JenniferF;Schoenbaum,Michael;Thompson,EllaE;Justice,Morgan;Zatzick,Douglas;Hamilton,LeahK;McMullen,CarmitK;Hallgren,KevinA;Benes,LindsayL;Forman,DavidP;Caldeiro,RyanM;Brow
背景阿片类药物使用障碍(OUD)导致发病率和死亡率的上升。可以在初级保健中提供挽救生命的OUD治疗，但大多数OUD患者不接受治疗。并发抑郁症和其他情况使OUD的管理复杂化，特别是在初级保健方面。MI-CARE试验是一项务实的随机鼓励(ZELEN)试验，测试为有OUD和临床显著抑郁症状的患者提供协作式护理(CC)是否增加了丁丙诺啡的OUD药物治疗，并与通常的护理相比改善了抑郁结局。方法来自两个全州医疗系统：凯撒永久华盛顿大学和印第安纳大学健康系统的成年初级保健患者(n≥：800)使用计算机算法从电子健康记录数据中识别并自动登记。在符合条件的患者中随机抽取一个子样本(50%)进行MI-CARE干预：为期12个月的护士驱动的CC干预，包括激励性访谈和行为激活。其余50%的研究队列包括常规护理对照组，从未联系过他们。主要结果是在干预期间提供丁丙诺啡治疗的天数。有动力的次要结果是患者健康问卷(PHQ)-9抑郁评分的变化。这两种结果都是从二级电子医疗保健来源获得的，并在“意向治疗”分析中进行了比较。结论MI-CARE解决了严格鼓励试验的必要性，以评估向患有OUD和EHR确定的精神健康状况的泛化样本提供CC的益处，就像他们在实践中所做的那样，并将结果与通常的初级保健进行比较。我们描述了目前正在进行的试验的设计和实现。试验注册：ClinicalTrials.gov标识符：NCT05122676。临床试验注册日期：2021年11月17日。
BackgroundOpioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care.MethodsAdult primary care patients with OUD and depressive symptoms (n≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients isofferedthe MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in “intent-to-treat” analyses.ConclusionMI-CARE addresses the need for rigorous encouragement trials to evaluate benefits ofofferingCC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway.Trial Registration: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021.