Substance Use Treatment and Recovery Team

Opioid-Related Disorders Clinical Trial

— START  

Official title:

Substance Use Treatment and Recovery Team

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086796
• Other study ID #: STUDY00000515
• Secondary ID: 5U01TR002756-021
• Status: Completed
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: December 19, 2023

Study information

• Verified date: May 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Baystate Health, National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA), RAND, Stanford University, University of New Mexico, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Linkage to follow-up OUD care	Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)	30 days
Secondary	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
Secondary	Any post-discharge MOUD utilization	Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)	30 days
Secondary	Post-discharge outpatient medical care	Completed at least one visit to an outpatient medical provider within 30 days of hospital discharge (Binary)	30 days
Secondary	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)	30 days