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Substance Use Treatment and Recovery Team

Substance Use Treatment and Recovery Team

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05086796
Acronym
START
Enrollment
325
Registered
2021-10-21
Start date
2021-11-11
Completion date
2023-12-19
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Related Disorders, Opioid-use Disorder

Keywords

Collaborative Care, Hospital, Addiction, Opioid Use Disorder

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.

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Linkage to Follow-up OUD Care30 daysAttended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
In-hospital Initiation of MOUD TherapyDuring the inpatient stay, an average of 7 daysInitiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)

Secondary

MeasureTime frameDescription
OUD-specific Discharge PlanDuring the inpatient stay, an average of 7 daysReceived an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)
Any Post-discharge MOUD Utilization30 daysInitiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)
Post-discharge Outpatient Medical Care30 daysCompleted 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 daysDays 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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: 1. Triage 2. Engage, Assess, and Plan 3. Treat 4. Communicate and Coordinate 5. Follow up 6. Monitor
164
Usual Care
Usual care for people with opioid use disorder.
161
Total325

Baseline characteristics

CharacteristicSubstance Use Treatment and Recovery Team (START)TotalUsual Care
Age, Continuous41.5 years41 years40 years
Ethnicity (NIH/OMB)
Hispanic or Latino
81 Participants156 Participants75 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
83 Participants169 Participants86 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
12 Participants28 Participants16 Participants
Race (NIH/OMB)
Asian
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
9 Participants21 Participants12 Participants
Race (NIH/OMB)
More than one race
10 Participants23 Participants13 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
65 Participants125 Participants60 Participants
Race (NIH/OMB)
White
66 Participants125 Participants59 Participants
Region of Enrollment
United States
164 participants325 participants161 participants
Sex: Female, Male
Female
64 Participants112 Participants48 Participants
Sex: Female, Male
Male
100 Participants213 Participants113 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1643 / 161
other
Total, other adverse events
1 / 1640 / 161
serious
Total, serious adverse events
4 / 1643 / 161

Outcome results

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)

Time frame: During the inpatient stay, an average of 7 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Substance Use Treatment and Recovery Team (START)In-hospital Initiation of MOUD Therapy94 Participants
Usual CareIn-hospital Initiation of MOUD Therapy43 Participants
97.5% CI: [1.51, 2.91]
Primary

Linkage to Follow-up OUD Care

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

Time frame: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who had a follow-up visit.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Substance Use Treatment and Recovery Team (START)Linkage to Follow-up OUD Care90 Participants
Usual CareLinkage to Follow-up OUD Care50 Participants
97.5% CI: [1.15, 1.93]
Secondary

Any Post-discharge MOUD Utilization

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

Time frame: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who had a follow-up visit and responded to this question.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Substance Use Treatment and Recovery Team (START)Any Post-discharge MOUD Utilization65 Participants
Usual CareAny Post-discharge MOUD Utilization32 Participants
95% CI: [1.23, 2.39]
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)

Time frame: During the inpatient stay, an average of 7 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Substance Use Treatment and Recovery Team (START)OUD-specific Discharge Plan81 Participants
Usual CareOUD-specific Discharge Plan44 Participants
95% CI: [1.35, 2.41]
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). 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

Time frame: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who responded to the question.

ArmMeasureValue (MEDIAN)
Substance Use Treatment and Recovery Team (START)Past 30-day Number of Days With Any Opioid Use0.0 days
Usual CarePast 30-day Number of Days With Any Opioid Use0.0 days
95% CI: [0.64, 2.43]
Secondary

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.

Time frame: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who had a follow-up visit and responded to this question.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Substance Use Treatment and Recovery Team (START)Post-discharge Outpatient Medical Care42 Participants
Usual CarePost-discharge Outpatient Medical Care19 Participants
95% CI: [1.18, 3.03]

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026