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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:
10372677
负责人:
E. Jennifer Edelman
金额:
$67.06万
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 groupEvaluationFrightFutureHealth 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 minority populationevidence basefood insecurityhealth care service utilizationhealth disparityhospital readmissionhousing instabilityimplementation scienceincremental cost-effectivenessindexinginformation gatheringinnovationlongitudinal analysismedical complicationmortalitymultidisciplinarypatient populationphosphatidylethanolprimary outcomeracial and ethnicracial diversityracial minorityresponseroutine caresecondary outcomesocial health determinantsthree-arm trialtrial design

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中文摘要
翻译
摘要 酒精使用障碍(AUD)是发病率和死亡率的主要原因,但往往得不到治疗。这是 在不同种族和民族背景的个人中尤其如此。急诊住院治疗 提供了一个尚未开发的机会来解决AUD治疗缺口。到目前为止,与AUD相关的护理主要集中在 浅谈急性戒断的治疗及相关急性内科并发症的处理 潜在的澳元。这忽略了一个“可治愈”的机会时刻。有一系列的行为和 可能在出院前开始的药物治疗,以解决AUD。然而,我们缺乏数据 关于加强出院后治疗参与度和减少酒精摄入量的最佳方法。 此外,结构性种族主义对更接近健康的社会决定因素(如住房)的影响 AUD住院患者的不稳定、医疗不信任)及其对治疗的影响 出院后的订婚和饮酒还没有得到很好的描述。我们提出了三臂假肢 随机试验比较影响:1)特定的简短干预,与简短的协商访谈 由健康促进倡导者单独向其他患者提供转介和为期两周的电话宣传(BNI) 2)为AUD提供药物(BNI Maud);3)认知行为的计算机平台 治疗(CBT4CBT;BNI Maud CBT4CBT)对450例住院患者的不同样本 在一家大型城市学术医疗中心,未经治疗的澳门氏症。主要结果是参与正式的澳元发展 在出院后30天进行治疗。次要结果包括正式的AUD治疗参与 在90天时,酒精使用的变化(通过自我报告和酒精生物标记物磷脂酰乙醇),以及, 卫生保健利用的探索性成果(目标1)。我们会探讨该计划的成效是否 不同种族和族裔群体之间和内部的干预措施不同,并以SDOH为基础(目标2)。与一项 混合类型1有效性-实施设计,我们将进行以实施为重点的流程 为未来的实施提供信息的评估,包括过程结果、临床医生和工作人员的观点、 和成本(目标3)。在新的和长期的合作基础上,研究团队包括具有 在医院环境下的成瘾药物方面的专门知识;行为干预,包括简单的干预和 技术传授的认知行为疗法;健康差异研究;临床试验;纵向 分析;以及实施科学。研究组件易于扩展,并植根于强有力的证据。 该建议提供了创新,因为1)医院的重点是启动AUD治疗;2)评估增加的 药物和CBT4CBT对BNI的好处;3)重点评估按种族、民族和 SDOH;4)审议结构性种族主义在研究设计和实施的所有方面的影响 拥有一支高素质的队伍。这项研究通过产生关于可再生和可再生的数据,有可能产生巨大的影响 可扩展的方法,在全国范围内转变以医院为基础的AUD治疗方案。
英文摘要
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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