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临床试验/NCT05086796
NCT05086796已完成不适用

Substance Use Treatment and Recovery Team

Cedars-Sinai Medical Center6 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
325
试验地点
6
主要终点
In-hospital Initiation of MOUD Therapy

研究概览

简要总结

This study is a multi-site, randomized pragmatic trial being conducted at three diverse sites. The study, called the Substance Use Treatment and Recovery Team (START), will evaluate whether a collaborative care team increases the use of two interventions-medication for opioid use disorder (MOUD), and opioid use disorder (OUD) focused discharge planning-among hospitalized patients with OUD, and improves linkage to follow-up care relative to usual care. The START consists of an addiction medicine specialist and a care manager who will use evidence-based tools to decrease barriers to MOUD and engage patients with post-discharge OUD care. A total of 414 patients will be randomized from Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts to receive either START or usual care, stratifying by prior MOUD exposure and site.

详细描述

In the past decade, hospitalizations for OUD nearly doubled. Patients admitted to the hospital with an underlying OUD rarely receive evidence-based treatment for OUD while hospitalized. MOUD is not commonly initiated in the hospital, and patients are seldom linked to outpatient treatment after discharge. Hospitalized patients with OUD who do not initiate MOUD or receive linkage to post-discharge treatment are at high-risk of continued misuse, delays in care, future overdose and costly readmission. This study identifies the inpatient hospital stay as a key opportunity to initiate MOUD and link patients with follow-up care for OUD.

The Substance Use Treatment and Recovery Team (START) is an intervention that adapts the principles of collaborative care to the hospital setting. Prior studies have demonstrated the effectiveness of collaborative care in outpatient settings for patients with opioid and alcohol use disorders, and a series of reports have demonstrated the feasibility and potential efficacy of hospital based consultative teams for substance use disorders. START uses team based, multi-faceted interventions (ie: motivational interviewing, medication treatment, OUD-focused discharge planning), measurement-based care, and patient registries to increase delivery of evidence-based care. The goal of START is to facilitate initiation of MOUD during the inpatient stay and link patients to appropriate post-discharge care.

The START study is a multi-site, randomized trial that will evaluate the intervention improves MOUD initiation and linkage to follow-up care among hospitalized patients with OUD. A total of 414 patients will be randomized from three geographically diverse hospitals (Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts) to receive either START or usual care, stratifying by prior MOUD exposure and site. The study builds on a pilot randomized controlled trial conducted at Cedars-Sinai by testing the intervention at three geographically distinct locations, thus increasing generalizability.

If the aims of the research are achieved, the investigators will learn whether this model of care increases OUD treatment delivery in general medical hospitals, and decreases the downstream effects of untreated OUD. If effective, this translational model also can be used to increase uptake of evidence-based practices for other substance use and behavioral health disorders.

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
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

入选标准

  • Admitted to an inpatient bed at Cedars-Sinai Medical Center (CSMC),University of New Mexico Hospital (UNM), or Baystate Health (BH)
  • Age 18 and older
  • Have a probable OUD diagnosis, defined by scores of > 3 on the opioid section of the Alcohol, Smoking, and Substance Involvement Screening test (ASSIST)
  • Speaks English or Spanish as primary language
  • Willing to participate in follow-up calls and interview by telephone and able to provide contact information for follow-up calls
  • Able to provide informed consent

排除标准

  • Currently receiving FDA-approved medication treatment for an opioid use disorder
  • < 6 months life expectancy

结局指标

主要结局

In-hospital Initiation of MOUD Therapy

时间窗: During the inpatient stay, an average of 7 days

Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)

Linkage to Follow-up OUD Care

时间窗: 30 days

Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)

次要结局

  • OUD-specific Discharge Plan(During the inpatient stay, an average of 7 days)
  • Any Post-discharge MOUD Utilization(30 days)
  • Post-discharge Outpatient Medical Care(30 days)
  • Past 30-day Number of Days With Any Opioid Use(30 days)

研究者

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

Itai Danovitch

Professor and Chair Department of Psychiatry & Behavioral Neurosciences

Cedars-Sinai Medical Center

研究点 (6)

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