Substance Use Treatment and Recovery Team (START)

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.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Substance Use Treatment and Recovery Team (START)

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.

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Triage; Engage, Assess, and Plan; Treat; Communicate and Coordinate; Follow up; Monitor
No Intervention: Usual Care; Usual care for people with opioid use disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OUD-specific Discharge Plan	Received an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)	During the inpatient stay, an average of 7 days
Any Post-discharge MOUD Utilization	Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)	30 days
Post-discharge Outpatient Medical Care	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.	30 days
Past 30-day Number of Days With Any Opioid Use	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	30 days

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); University of Pittsburgh; Stanford University; National Center for Advancing Translational Sciences (NCATS); RAND; University of New Mexico; Baystate Health
• Investigators: Principal Investigator: Itai Danovitch, MD, Cedars-Sinai Medical Center; Principal Investigator: Allison J Ober, PhD, RAND

Publications and helpful links

General Publications

• Ober 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Hospital; Addiction; Collaborative Care
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: STUDY00000515; 5U01TR002756-02 (U.S. NIH Grant/Contract); 1U01TR002756-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: IPD will be available upon completion of analyses until five years after study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No