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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01TR002756-02 | U.S. NIH Grant/Contract | View source | |
| 1U01TR002756-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| RAND | OTHER |
| University of New Mexico | OTHER |
| Baystate Health | OTHER |
| National Center for Advancing Translational Sciences (NCATS) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substance Use Treatment and Recovery Team (START) | Active Comparator | 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 | No Intervention | Usual care for people with opioid use disorder. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Substance Use Treatment and Recovery Team (START) | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Linkage to Follow-up OUD Care | Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Any Post-discharge MOUD Utilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itai Danovitch, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Allison J Ober, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Baystate Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40193131 | Derived | Ober AJ, Murray-Krezan C, Page K, Friedmann PD, Anderson J, Osilla KC, Ryzewicz S, Huerta S, Mazer MW, Hoskinson RA, Garvey R, Peltz A, Watkins KE, Nuckols T, IsHak WW, Mariano LT, Danovitch I. Hospital Addiction Consultation Service and Opioid Use Disorder Treatment: The START Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):624-633. doi: 10.1001/jamainternmed.2024.8586. | |
| 35902888 | Derived | 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. |
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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 will be available upon completion of analyses until five years after study completion.
(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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| FG001 | Usual Care | Usual care for people with opioid use disorder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention-to-treat population defined as all participants who met eligibility criteria, consented, and were randomized to one of the two treatment arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms. | Posted | Count of Participants | Participants | During the inpatient stay, an average of 7 days |
|
90 days - from date of enrollment to end of follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Necrotizing oft-tissue infection (NSTI) | Infections and infestations | Non-systematic Assessment | Led to death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grievance | Social circumstances | Non-systematic Assessment | Subject grievance expressed during a call in an effort to conduct the follow-up interview. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Itai Danovitch, MD | Cedars-Sinai Medical Center | 310-423-2600 | itai.danovitch@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2023 | Dec 18, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2024 | Dec 17, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2022 | May 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
| Stanford University | OTHER |
| University of Pittsburgh | OTHER |
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|
Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)
| 30 days |
| 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. | 30 days |
| 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 | 30 days |
| Springfield |
| Massachusetts |
| 01199 |
| United States |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | United States |
| BG001 | Usual Care | Usual care for people with opioid use disorder. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Usual care for people with opioid use disorder. |
|
|
|
| Primary | Linkage to Follow-up OUD Care | Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary) | 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. | Posted | Count of Participants | Participants | 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) | Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms. | Posted | Count of Participants | Participants | 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) | 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. | Posted | Count of Participants | Participants | 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). Visit must be specifically related to opioid use and may include an emergency department visit. | 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. | Posted | Count of Participants | Participants | 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). "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 | Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who responded to the question. | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
|
| 3 |
| 164 |
| 4 |
| 164 |
| 1 |
| 164 |
| EG001 | Usual Care | Usual care for people with opioid use disorder. | 3 | 161 | 3 | 161 | 0 | 161 |
|
| Investigations | Non-systematic Assessment | Led to death |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment | Led to death |
|
| Hospitalized | Psychiatric disorders | Non-systematic Assessment |
|
|
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| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |