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| ID | Type | Description | Link |
|---|---|---|---|
| 2UG1DA040316-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.
The study will randomize approximately 24 community hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD. Community hospitals will be randomized 1:1 to implement a low- or high-intensity strategy. Hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in HBOT. The randomization will be stratified by site/hub. Participants will be assessed for "engagement with MOUD", measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention. Further outcomes will be assessed during the entire 4-year study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Intensity | Active Comparator | MOUD training and support through the use of educational materials. |
|
| High Intensity | Experimental | MOUD training and support through the use of educational materials in addition to practice facilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity | Other | Training and education only, a low-intensity strategy inclusive of an HBOT manual, one-time live training on how to use the HBOT manual, and 7 video conference presentations. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement with MOUD | measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention. | 34 days following hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gavin Bart, MD,PhD | Hennepin Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02119 | United States | ||
| Hennepin Healthcare Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28673521 | Background | Trowbridge P, Weinstein ZM, Kerensky T, Roy P, Regan D, Samet JH, Walley AY. Addiction consultation services - Linking hospitalized patients to outpatient addiction treatment. J Subst Abuse Treat. 2017 Aug;79:1-5. doi: 10.1016/j.jsat.2017.05.007. Epub 2017 May 11. | |
| 20957426 | Background | Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. |
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Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on the National Institute on Drug Abuse (NIDA) Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. De-identified individual participant data is expected to be made available.
The data will be shared after the primary outcome paper has been accepted for publication, or 18 months after data lock, whichever comes first. The data will remain indefinitely.
Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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This is a multi-site, cluster randomized, two group implementation trial comparing a low versus high intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented. Approximately 24 hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD, will be randomized 1:1 to implement a low- or high-intensity strategy. Hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in HBOT. The randomization will be stratified by site/hub.
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| High Intensity | Other | Practice facilitation, a high-intensity strategy inclusive of low-intensity training, plus practice facilitation that is based in part on a program planning model. This study is a hybrid implementation effectiveness design, testing an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. |
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| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| New York University | New York | New York | 10016 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| 25889199 | Background | Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1. |
| 38600571 | Derived | Bart G, Korthuis PT, Donohue JM, Hagedorn HJ, Gustafson DH, Bazzi AR, Enns E, McNeely J, Ghitza UE, Magane KM, Baukol P, Vena A, Harris J, Voronca D, Saitz R. Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder. Addict Sci Clin Pract. 2024 Apr 11;19(1):29. doi: 10.1186/s13722-024-00455-9. |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D012959 |
| Socioeconomic Factors |
| D011154 | Population Characteristics |