Clinical trial NCT05086796: Substance Use Treatment and Recovery Team
Official title: Substance Use Treatment and Recovery Team
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid-Related Disorders
Keywords: Collaborative Care
Hospital
Addiction
Opioid Use Disorder
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: RAND
name: University of New Mexico
name: Baystate Health
name: National Center for Advancing Translational Sciences (NCATS)
name: National Institute on Drug Abuse (NIDA)
name: Stanford University
name: University of Pittsburgh
First posted: 2021-10-21
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: In-hospital Initiation of MOUD Therapy
timeFrame: During the inpatient stay, an average of 7 days
measure: Linkage to Follow-up OUD Care
timeFrame: 30 days
Secondary outcomes:
measure: OUD-specific Discharge Plan
timeFrame: During the inpatient stay, an average of 7 days
measure: Any Post-discharge MOUD Utilization
timeFrame: 30 days
measure: Post-discharge Outpatient Medical Care
timeFrame: 30 days
measure: Past 30-day Number of Days With Any Opioid Use
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Itai Danovitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: Allison J Ober, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.