Substance Use Treatment and Recovery Team
START
3 other identifiers
interventional
325
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedStudy Start
First participant enrolled
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2023
CompletedResults Posted
Study results publicly available
January 14, 2025
CompletedJanuary 23, 2025
January 1, 2025
2.1 years
October 12, 2021
December 19, 2024
January 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
In-hospital Initiation of MOUD Therapy
Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)
During the inpatient stay, an average of 7 days
Linkage to Follow-up OUD Care
Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
30 days
Secondary Outcomes (4)
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
Study Arms (2)
Substance Use Treatment and Recovery Team (START)
ACTIVE COMPARATORThe 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.
Usual Care
NO INTERVENTIONUsual care for people with opioid use disorder.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently receiving FDA-approved medication treatment for an opioid use disorder
- \< 6 months life expectancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- RANDcollaborator
- University of New Mexicocollaborator
- Baystate Healthcollaborator
- National Center for Advancing Translational Sciences (NCATS)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
- Stanford Universitycollaborator
- University of Pittsburghcollaborator
Study Sites (3)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
Related Publications (2)
Ober AJ, Murray-Krezan C, Page K, Friedmann PD, Anderson J, Osilla KC, Ryzewicz S, Huerta S, Mazer MW, Hoskinson RA, Garvey R, Peltz A, Watkins KE, Nuckols T, IsHak WW, Mariano LT, Danovitch I. Hospital Addiction Consultation Service and Opioid Use Disorder Treatment: The START Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):624-633. doi: 10.1001/jamainternmed.2024.8586.
PMID: 40193131DERIVEDOber AJ, Murray-Krezan C, Page K, Friedmann PD, Chan Osilla K, Ryzewicz S, Huerta S, Mazer MW, Leamon I, Messineo G, Watkins KE, Nuckols T, Danovitch I. The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder. Addict Sci Clin Pract. 2022 Jul 28;17(1):39. doi: 10.1186/s13722-022-00320-7.
PMID: 35902888DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Itai Danovitch, MD
- Organization
- Cedars-Sinai Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Itai Danovitch, MD
Cedars-Sinai Medical Center
- PRINCIPAL INVESTIGATOR
Allison J Ober, PhD
RAND
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair Department of Psychiatry & Behavioral Neurosciences
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 21, 2021
Study Start
November 11, 2021
Primary Completion
December 19, 2023
Study Completion
December 19, 2023
Last Updated
January 23, 2025
Results First Posted
January 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.