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Substance Use Treatment and Recovery Team

Not Applicable
Completed
Conditions
Opioid-use Disorder
Opioid-Related Disorders
Interventions
Behavioral: Substance Use Treatment and Recovery Team (START)
Registration Number
NCT05086796
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
325
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Substance Use Treatment and Recovery Team (START)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.
Primary Outcome Measures
NameTimeMethod
In-hospital Initiation of MOUD TherapyDuring 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 Care30 days

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

Secondary Outcome Measures
NameTimeMethod
OUD-specific Discharge PlanDuring 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)

Any Post-discharge MOUD Utilization30 days

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

Post-discharge Outpatient Medical Care30 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.

Past 30-day Number of Days With Any Opioid Use30 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

Trial Locations

Locations (3)

University of New Mexico Hospital

🇺🇸

Albuquerque, New Mexico, United States

Baystate Medical Center

🇺🇸

Springfield, Massachusetts, United States

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

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