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临床试验/NCT04559893
NCT04559893已完成不适用

Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness

RAND32 个研究点 分布在 1 个国家目标入组 729 人开始时间: 2021年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
729
试验地点
32
主要终点
Buprenorphine access

研究概览

简要总结

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.

详细描述

Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET).

The current study consists of a multi-site, randomized pragmatic trial in rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico and California to adapt, harmonize and then test whether CC-COD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 and older
  • Receiving primary care at one of the participating clinical sites
  • Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD)

排除标准

  • Does not speak English or Spanish
  • Unable to consent
  • Receiving both MOUD and psychotropic medication from a provider outside of the primary care health system at which the patient is enrolled
  • Not receiving primary care at one of the participating clinical sites

结局指标

主要结局

Buprenorphine access

时间窗: Assessed at 6 months after study entry.

Number of days until first buprenorphine prescription after study enrollment for study participants with a new episode of OUD care (no care for at least 30 days prior). Obtained from the Prescription Drug Monitoring Program and patient survey.

Buprenorphine continuity of care

时间窗: Assessed at 6 months after study entry.

The cumulative number of days the patient receives buprenorphine during the 180 days after study enrollment for study participants not on methadone at baseline. Obtained from the Prescription Drug Monitoring Program and patient survey.

Major Depressive Disorder (MDD) symptom severity

时间窗: Assessed at 6 months after study entry.

Sum of items (0-27) in the PHQ-9 (Patient Health Questionnaire) at 6 months for participants with probable major depression at baseline.

Post-traumatic Stress Disorder (PTSD) symptom severity

时间窗: Assessed at 6 months after study entry.

Sum of items (0-80) in PCL-5 at 6 months for study participants with probable PTSD at baseline.

次要结局

  • Access to MDD and/or PTSD treatment(Assessed at 30 days and 180 days after study entry.)
  • Quality of care for MDD(Assessed at 6 months after study entry.)
  • Quality of care for PTSD(Assessed at 6 months after study entry.)
  • MDD remission(Assessed at 6 months after study entry)
  • MDD response(Assessed at 6 months after study entry.)
  • PTSD remission(Assessed at 6 months after study entry.)
  • PTSD response(Assessed at 6 months after study entry.)
  • Active suicidal ideation(Assessed at 6 months after study entry.)
  • Opioid use frequency(Assessed over 30 days after study entry.)
  • Opioid overdose events(Assessed over the previous 3 months after study entry.)
  • Physical health functioning(Assessed at 30 days after study entry)
  • Mental health functioning(Assessed at 30 days after study entry)

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Watkins

Senior Physician Policy Researcher

RAND

研究点 (32)

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