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Completed

NCT Number: NCT05086796

Substance Use Treatment and Recovery Team

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Substance Use Treatment and Recovery Team (START)

Behavioral

START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid use disorder and to increase linkage to aftercare.

The components of the START intervention are as follows:

  • Triage
  • Engage, Assess, and Plan
  • Treat
  • Communicate and Coordinate
  • Follow up
  • Monitor

Primary outcomes

  1. In-hospital Initiation of MOUD Therapy

    Time frame: 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)

  2. Linkage to Follow-up OUD Care

    Time frame: 30 days

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

Secondary outcomes

  1. OUD-specific Discharge Plan

    Time frame: During the inpatient stay, an average of 7 days

    Received an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)

  2. Any Post-discharge MOUD Utilization

    Time frame: 30 days

    Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)

  3. Post-discharge Outpatient Medical Care

    Time frame: 30 days

    Completed at least one visit to an outpatient medical provider within 30 days of hospital discharge (Binary). Visit must be specifically related to opioid use and may include an emergency department visit.

  4. Past 30-day Number of Days With Any Opioid Use

    Time frame: 30 days

    Days of use in the past 30 days after hospital discharge - Adapted National Survey of Drug Use and Health (NSDUH) (Continuous). "Use-days" range from 0 to 120 days with up to 30 days of use reportable for each of four opioid categories: pain medications excluding fentanyl, fentanyl, heroin/opium alone, heroin/opium mixed with another drug

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Baystate Health
  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute on Drug Abuse (NIDA)
  • RAND
  • Stanford University
  • University of New Mexico
  • University of Pittsburgh

Registry information

Acronym: START

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2021
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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