Substance Use Treatment and Recovery Team (START)
Primary Purpose
Opioid-use Disorder, Opioid-Related Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Substance Use Treatment and Recovery Team (START)
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring Collaborative Care, Hospital, Addiction, Opioid Use Disorder
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
Sites / Locations
- Cedars Sinai Medical Center
- Baystate Medical Center
- University of New Mexico Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Substance Use Treatment and Recovery Team (START)
Usual Care
Arm Description
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.
Usual care for people with opioid use disorder.
Outcomes
Primary Outcome Measures
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)
Linkage to follow-up OUD care
Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
Secondary Outcome Measures
OUD-specific discharge plan
Received an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)
Any post-discharge MOUD utilization
Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)
Post-discharge outpatient medical care
Completed at least one visit to an outpatient medical provider within 30 days of hospital discharge (Binary)
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)
Full Information
NCT ID
NCT05086796
First Posted
October 12, 2021
Last Updated
October 5, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
RAND, University of New Mexico, Baystate Health, National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA), Stanford University, University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT05086796
Brief Title
Substance Use Treatment and Recovery Team
Acronym
START
Official Title
Substance Use Treatment and Recovery Team
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
RAND, University of New Mexico, Baystate Health, National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA), Stanford University, University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid-Related Disorders
Keywords
Collaborative Care, Hospital, Addiction, Opioid Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Substance Use Treatment and Recovery Team (START)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care for people with opioid use disorder.
Intervention Type
Behavioral
Intervention Name(s)
Substance Use Treatment and Recovery Team (START)
Intervention Description
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
Primary Outcome Measure Information:
Title
In-hospital initiation of MOUD therapy
Description
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
Title
Linkage to follow-up OUD care
Description
Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
OUD-specific discharge plan
Description
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
Title
Any post-discharge MOUD utilization
Description
Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)
Time Frame
30 days
Title
Post-discharge outpatient medical care
Description
Completed at least one visit to an outpatient medical provider within 30 days of hospital discharge (Binary)
Time Frame
30 days
Title
Past 30-day number of days with any opioid use
Description
Days of use in the past 30 days after hospital discharge - Adapted National Survey of Drug Use and Health (NSDUH) (Continuous)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itai Danovitch, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison J Ober, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35902888
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.
Results Reference
derived
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