Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population
Abstract Background Alcohol use disorder (AUD) commonly causes hospitalization, particularly for individuals disproportionately impacted by structural racism and other forms of marginalization. The optimal approach for engaging hospitalized patients with AUD in treatment post-hospital discharge is u...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | Addiction Science & Clinical Practice |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13722-023-00407-9 |
| _version_ | 1797451876123279360 |
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| author | E. Jennifer Edelman Oscar F. Rojas-Perez Charla Nich Joanne Corvino Tami Frankforter Derrick Gordon Ayana Jordan Manuel Paris, Jr Melissa B. Weimer Brian T. Yates Emily C. Williams Brian D. Kiluk |
| author_facet | E. Jennifer Edelman Oscar F. Rojas-Perez Charla Nich Joanne Corvino Tami Frankforter Derrick Gordon Ayana Jordan Manuel Paris, Jr Melissa B. Weimer Brian T. Yates Emily C. Williams Brian D. Kiluk |
| author_sort | E. Jennifer Edelman |
| collection | DOAJ |
| description | Abstract Background Alcohol use disorder (AUD) commonly causes hospitalization, particularly for individuals disproportionately impacted by structural racism and other forms of marginalization. The optimal approach for engaging hospitalized patients with AUD in treatment post-hospital discharge is unknown. We describe the rationale, aims, and protocol for Project ENHANCE (ENhancing Hospital-initiated Alcohol TreatmeNt to InCrease Engagement), a clinical trial testing increasingly intensive approaches using a hybrid type 1 effectiveness-implementation approach. Methods We are randomizing English and/or Spanish-speaking individuals with untreated AUD (n = 450) from a large, urban, academic hospital in New Haven, CT to: (1) Brief Negotiation Interview (with referral and telephone booster) alone (BNI), (2) BNI plus facilitated initiation of medications for alcohol use disorder (BNI + MAUD), or (3) BNI + MAUD + initiation of computer-based training for cognitive behavioral therapy (CBT4CBT, BNI + MAUD + CBT4CBT). Interventions are delivered by Health Promotion Advocates. The primary outcome is AUD treatment engagement 34 days post-hospital discharge. Secondary outcomes include AUD treatment engagement 90 days post-discharge and changes in self-reported alcohol use and phosphatidylethanol. Exploratory outcomes include health care utilization. We will explore whether the effectiveness of the interventions on AUD treatment engagement and alcohol use outcomes differ across and within racialized and ethnic groups, consistent with disproportionate impacts of AUD. Lastly, we will conduct an implementation-focused process evaluation, including individual-level collection and statistical comparisons between the three conditions of costs to providers and to patients, cost-effectiveness indices (effectiveness/cost ratios), and cost–benefit indices (benefit/cost ratios, net benefit [benefits minus costs). Graphs of individual- and group-level effectiveness x cost, and benefits x costs, will portray relationships between costs and effectiveness and between costs and benefits for the three conditions, in a manner that community representatives also should be able to understand and use. Conclusions Project ENHANCE is expected to generate novel findings to inform future hospital-based efforts to promote AUD treatment engagement among diverse patient populations, including those most impacted by AUD. Clinical Trial Registration: Clinicaltrials.gov identifier: NCT05338151. |
| first_indexed | 2024-03-09T15:00:31Z |
| format | Article |
| id | doaj.art-1de87aee7ea14ac9b1bd3c9b21b079e6 |
| institution | Directory Open Access Journal |
| issn | 1940-0640 |
| language | English |
| last_indexed | 2024-03-09T15:00:31Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj.art-1de87aee7ea14ac9b1bd3c9b21b079e62023-11-26T13:56:01ZengBMCAddiction Science & Clinical Practice1940-06402023-09-0118111610.1186/s13722-023-00407-9Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient populationE. Jennifer Edelman0Oscar F. Rojas-Perez1Charla Nich2Joanne Corvino3Tami Frankforter4Derrick Gordon5Ayana Jordan6Manuel Paris, Jr7Melissa B. Weimer8Brian T. Yates9Emily C. Williams10Brian D. Kiluk11Department of Internal Medicine, Yale School of MedicineDepartment of Psychiatry, Yale School of MedicineDepartment of Psychiatry, Yale School of MedicineDepartment of Psychiatry, Yale School of MedicineDepartment of Psychiatry, Yale School of MedicineDepartment of Psychiatry, Yale School of MedicineDepartment of Psychiatry, NYU Langone HealthDepartment of Psychiatry, Yale School of MedicineDepartment of Internal Medicine, Yale School of MedicineDepartment of Psychology, American UniversityDepartment of Health Systems and Population Health, University of Washington School of Public HealthYale Program in Addiction Medicine, Yale School of MedicineAbstract Background Alcohol use disorder (AUD) commonly causes hospitalization, particularly for individuals disproportionately impacted by structural racism and other forms of marginalization. The optimal approach for engaging hospitalized patients with AUD in treatment post-hospital discharge is unknown. We describe the rationale, aims, and protocol for Project ENHANCE (ENhancing Hospital-initiated Alcohol TreatmeNt to InCrease Engagement), a clinical trial testing increasingly intensive approaches using a hybrid type 1 effectiveness-implementation approach. Methods We are randomizing English and/or Spanish-speaking individuals with untreated AUD (n = 450) from a large, urban, academic hospital in New Haven, CT to: (1) Brief Negotiation Interview (with referral and telephone booster) alone (BNI), (2) BNI plus facilitated initiation of medications for alcohol use disorder (BNI + MAUD), or (3) BNI + MAUD + initiation of computer-based training for cognitive behavioral therapy (CBT4CBT, BNI + MAUD + CBT4CBT). Interventions are delivered by Health Promotion Advocates. The primary outcome is AUD treatment engagement 34 days post-hospital discharge. Secondary outcomes include AUD treatment engagement 90 days post-discharge and changes in self-reported alcohol use and phosphatidylethanol. Exploratory outcomes include health care utilization. We will explore whether the effectiveness of the interventions on AUD treatment engagement and alcohol use outcomes differ across and within racialized and ethnic groups, consistent with disproportionate impacts of AUD. Lastly, we will conduct an implementation-focused process evaluation, including individual-level collection and statistical comparisons between the three conditions of costs to providers and to patients, cost-effectiveness indices (effectiveness/cost ratios), and cost–benefit indices (benefit/cost ratios, net benefit [benefits minus costs). Graphs of individual- and group-level effectiveness x cost, and benefits x costs, will portray relationships between costs and effectiveness and between costs and benefits for the three conditions, in a manner that community representatives also should be able to understand and use. Conclusions Project ENHANCE is expected to generate novel findings to inform future hospital-based efforts to promote AUD treatment engagement among diverse patient populations, including those most impacted by AUD. Clinical Trial Registration: Clinicaltrials.gov identifier: NCT05338151.https://doi.org/10.1186/s13722-023-00407-9Alcohol use disorderImplementation scienceClinical trial protocolRacialized and ethnic minoritized communities |
| spellingShingle | E. Jennifer Edelman Oscar F. Rojas-Perez Charla Nich Joanne Corvino Tami Frankforter Derrick Gordon Ayana Jordan Manuel Paris, Jr Melissa B. Weimer Brian T. Yates Emily C. Williams Brian D. Kiluk Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population Addiction Science & Clinical Practice Alcohol use disorder Implementation science Clinical trial protocol Racialized and ethnic minoritized communities |
| title | Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population |
| title_full | Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population |
| title_fullStr | Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population |
| title_full_unstemmed | Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population |
| title_short | Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population |
| title_sort | promoting alcohol treatment engagement post hospitalization with brief intervention medications and cbt4cbt protocol for a randomized clinical trial in a diverse patient population |
| topic | Alcohol use disorder Implementation science Clinical trial protocol Racialized and ethnic minoritized communities |
| url | https://doi.org/10.1186/s13722-023-00407-9 |
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