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Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications, and CBT4CBT: A randomized clinical trial in a diverse patient population

Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications, and CBT4CBT: A randomized clinical trial in a diverse patient population
通过简短干预、药物和 CBT4CBT 促进住院后酒精治疗的参与:针对不同患者群体的随机临床试验
批准号:
10491299
负责人:
E. Jennifer Edelman
金额:
$72.79万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
未结题
起止时间:
2021-09-20 至 2026-05-31
关键词:
Academic Medical CentersAccident and Emergency departmentAcuteAddressAdvocateAlcohol consumptionAlcoholsBehavior TherapyBehavioralBiological MarkersBlack, Indigenous, People of ColorCaringClinical TrialsCognitive TherapyCollaborationsComputerized Cognitive Behavioral TherapyComputersCost Effectiveness AnalysisDataDisadvantagedDiscriminationDissemination and ImplementationEducational StatusEffectiveness of InterventionsEmergency department visitEthnic OriginEthnic groupEvaluationFrightHealth Disparities ResearchHealth PromotionHealth ServicesHealth Services AccessibilityHeavy DrinkingHospitalizationHospitalsHybridsIndividualInterviewLeftMediationMedicalMedicineMorbidity - disease rateOutcomePatient Self-ReportPatientsPersonsPharmaceutical PreparationsPlant RootsProcessProcess MeasureRaceRandomized Clinical TrialsReach Effectiveness Adoption Implementation and MaintenanceReproducibilityResearchResearch DesignResourcesSamplingStandardizationStigmatizationStructural RacismSurveysTechnologyTelephoneTimeUnited StatesUnited States Food and Drug AdministrationUrban HospitalsWithdrawalWorkaddictionalcohol abuse therapyalcohol consequencesalcohol interventionalcohol use disorderbasebrief interventioncare outcomesclinically relevantcompare effectivenesscostcost-effectiveness ratiodigital interventiondisparity reductioneffectiveness evaluationeffectiveness implementation designethnic minorityevidence basefood insecurityfuture implementationhealth care service utilizationhospital readmissionhousing instabilityimplementation scienceincremental cost-effectivenessindexinginformation gatheringinnovationlongitudinal analysismedical complicationmortalitymultidisciplinarypatient populationphosphatidylethanolprimary outcomeprocess evaluationracial and ethnicracial diversityracial minorityresponseroutine caresecondary outcomesocial health determinantsthree-arm trialtrial design

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ABSTRACT Alcohol use disorder (AUD) is a major cause of morbidity and mortality, yet often goes untreated. This is particularly true among individuals of diverse racial and ethnic backgrounds. Acute medical hospitalization provides an untapped opportunity to address the AUD treatment gap. To date, AUD-related care has focused on treatment of acute withdrawal and addressing associated acute medical complications without addressing the underlying AUD. This overlooks an opportunity “treatable” moment. There are a range of behavioral and medication treatments that may be initiated prior to hospital discharge to address AUD. However, we lack data on the optimal approach to enhance post-discharge AUD treatment engagement and alcohol reduction. Further, the influence of structural racism on more proximal social determinants of health (SDOH, e.g., housing instability, medical mistrust) among patients hospitalized with AUD and their resulting impact on treatment engagement and alcohol use post-discharge has not been well characterized. We propose a 3-arm randomized trial to compare the impact of: 1) a specific brief intervention, the Brief Negotiated Interview with referral and 2-week telephone booster (BNI) delivered by a health promotion advocate alone to the additional 2) provision of medications for AUD (BNI+MAUD), and 3) the computer-based platform of cognitive behavioral therapy (CBT4CBT; BNI+MAUD+CBT4CBT) among a diverse sample of 450 patients hospitalized with untreated AUD at a large, urban academic medical center. The primary outcome is engagement in formal AUD treatment at 30 days post-hospital discharge. Secondary outcomes include formal AUD treatment engagement at 90 days, changes in alcohol use (by self-report and the alcohol biomarker, phosphatidylethanol), and, the exploratory outcome of healthcare utilization (Aim 1). We will explore whether the effectiveness of the interventions differ across and within racial and ethnic groups and based on SDOH (Aim 2). Consistent with a hybrid type 1 effectiveness-implementation design, we will conduct an implementation-focused process evaluation to inform future implementation, including process outcomes, perspectives from clinicians and staff, and cost (Aim 3). Building on new and longstanding collaborations, the study team includes individuals with expertise in addiction medicine in hospital settings; behavioral interventions, including brief interventions and technology-delivered cognitive behavioral therapy; health disparities research; clinical trials; longitudinal analysis; and implementation science. Study components are readily-scalable and rooted in strong evidence. This proposal offers innovation given the 1) hospital focus for AUD treatment initiation; 2) evaluation of added benefit of medications and CBT4CBT to BNI; 3) focus on evaluation of differential effects by race, ethnicity and SDOH; 4) consideration of the impact of structural racism in all aspects of study design and implementation with a highly qualified team. The study has potential for high impact by generating data on reproducible and scalable approaches to transform hospital-based AUD treatment initiation nationally.
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  • 项目类别:
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  • 财政年份:
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  • 财政年份:
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  • 依托单位:
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  • 财政年份:
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