Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA.
Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
Contemp Clin Trials. 2021 Apr;103:106325. doi: 10.1016/j.cct.2021.106325. Epub 2021 Feb 22.
People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown.
The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.
The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis.
www.clinicaltrials.gov registration: NCT04245423.
患有阿片类药物使用障碍（OUD）的人通常伴有并存的精神疾病，这会增加发病率和死亡率。有前途的证据支持在初级保健中使用协作护理来治疗 OUD 患者。目前尚不清楚治疗 OUD 和并存精神障碍的协作护理干预措施是否会带来更好的结果。
全健康研究是一项 3 臂随机对照试验，旨在测试针对 OUD 以及 OUD 常见并存的精神障碍的协作护理治疗。大约 1200 名年龄≥18 岁的患有 OUD 和抑郁、焦虑或 PTSD 的初级保健患者将被随机分配到以下三种情况之一：（1）增强常规护理，包括获得授权开具丁丙诺啡的初级保健医生（PCP）和咨询药物辅助治疗的成瘾精神病医生；（2）协作护理，包括获得授权的 PCP、接受过 OUD 和精神障碍心理社会治疗培训的心理健康护理经理，以及提供 OUD 和心理健康咨询的成瘾精神病医生；（3）协作护理加，包括协作护理臂的所有要素以及认证的康复专家，以帮助治疗参与和保留。主要结果是六个月时阿片类药物使用的发生率和六个月时并存精神障碍缓解的发生率。
全健康研究将调查解决 OUD 和并存的抑郁、焦虑或 PTSD 的协作护理模式是否会带来更好的患者结果。研究结果将为当前阿片类药物危机期间的临床护理提供信息。
www.clinicaltrials.gov 注册：NCT04245423。
