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Substance Use Treatment and Recovery Team (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05086796
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : July 18, 2022
Sponsor:
Collaborators:
RAND
University of New Mexico
Baystate Health
National Center for Advancing Translational Sciences (NCATS)
National Institute on Drug Abuse (NIDA)
Stanford University
University of Pittsburgh
Information provided by (Responsible Party):
Itai Danovitch, Cedars-Sinai Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opioid-Related Disorders Behavioral: Substance Use Treatment and Recovery Team (START) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substance Use Treatment and Recovery Team
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Arm Intervention/treatment
Active Comparator: Substance Use Treatment and Recovery Team (START)
The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder.
Behavioral: Substance Use Treatment and Recovery Team (START)

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:

  1. Triage
  2. Engage, Assess, and Plan
  3. Treat
  4. Communicate and Coordinate
  5. Follow up
  6. Monitor

No Intervention: Usual Care
Usual care for people with opioid use disorder.



Primary Outcome Measures :
  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 Outcome Measures :
  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)

  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086796


Contacts
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Contact: Mia Mazer 424-315-2642 mazerm@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mia Mazer    424-315-2642    mazerm@cshs.org   
Principal Investigator: Itai Danovitch, MD         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Randall Hoskinson    413-794-7034    Randall.HoskinsonJr@baystatehealth.org   
Principal Investigator: Peter D Friedmann, MD         
United States, New Mexico
University of New Mexico Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Kimberly Page, PhD    505-272-2520    pagek@salud.unmpagek@salud.unm.edu   
Principal Investigator: Kimberly Page, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
RAND
University of New Mexico
Baystate Health
National Center for Advancing Translational Sciences (NCATS)
National Institute on Drug Abuse (NIDA)
Stanford University
University of Pittsburgh
Investigators
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Principal Investigator: Itai Danovitch, MD Cedars-Sinai Medical Center
Principal Investigator: Allison J Ober, PhD RAND
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Itai Danovitch, Professor and Chair Department of Psychiatry & Behavioral Neurosciences, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05086796    
Other Study ID Numbers: STUDY00000515
5U01TR002756-02 ( U.S. NIH Grant/Contract )
1U01TR002756-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data and associated documentation will be made available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: IPD will be available upon completion of analyses until five years after study completion.
Access Criteria: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Itai Danovitch, Cedars-Sinai Medical Center:
Collaborative Care
Hospital
Addiction
Opioid Use Disorder
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders