Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models

描述（由申请人提供）：对初级保健患者的药物使用进行短暂干预的效果尚不清楚。因此，国家专业组织不建议普遍筛查。然而，可以为这种筛查提供强有力的理论依据：药物使用是常见的，并与许多健康后果有关，患者通常不寻求帮助，筛查和短暂干预已被证明对其他物质使用（例如酒精）有效。政策在此基础上得到了发展：联邦政府正在大力推广筛查和简短干预措施，保险公司为这些活动补偿临床医生的报销代码也已制定。科学和这些政策发展之间的差异强调了在筛查确定的患者中测试短暂干预效果的必要性。本研究的目的是评估筛查加简短干预对停止药物使用的疗效（ASPIRE）研究，旨在确定两种简短干预模式对减少初级保健患者药物使用和后果的疗效。作为联邦项目的一部分，我们将与一个实施筛查和短暂干预的州项目合作，在一家大型医院的初级保健实践中对患者进行药物使用筛查。然后，我们将招募1800名筛查阳性的受试者，将他们随机分为3组，随访6个月。一个干预组的受试者将被分配到一个标准的简短干预模式，由训练有素的健康促进倡导者指导，作为广泛传播的联邦计划在当地实施的一部分。在另一组中，受试者将被分配到一个增强的、更密集的简短干预模式，该模式包括一个助推器接触，并由经过培训和集中监控的硕士级别辅导员进行动机访谈。对照组将收到信息（即，一份当地帮助吸毒者的资源的书面清单），在六个月后，如果他们仍在吸毒，将接受标准的简短干预。主要结果是在6个月时戒断药物使用和药物使用后果，包括艾滋病毒风险行为，并接受物质依赖治疗（在依赖者中）。我们还将比较与每组相关的成本和结果。主要假设为：1)增强的短期干预模式在提高戒断率、降低吸毒后果（包括hiv风险行为）和增加接受治疗方面比单纯的筛查和资源信息（对照）更有效；2)在相同的结果下，标准的短期干预模式比对照更有效；3)增强的短期干预比标准的短期干预更有效。我们还假设，与其他组相比，强化的短暂干预将有更高的实施成本，但更低的净干预成本（实施、未来医疗保健和犯罪成本）。这项研究的结果——药物使用短暂干预的有效性和成本——将对在初级保健机构中传播药物使用筛查和短暂干预的决策至关重要。公共卫生相关性：药物使用代价高昂，可造成很大伤害，而且往往得不到治疗。初级保健机构提供的简短干预措施可以惠及许多吸毒者。这项拟议的临床试验将评估这些简短干预措施的有效性，因此具有相关性，因为如果这些简短干预措施被证明是有效的，它们的传播可以显著减少国家的药物使用负担。

DESCRIPTION (provided by applicant): The efficacy of brief intervention for drug use among primary care patients is not known. As a result, national professional organizations do not recommend universal screening. Yet a strong theoretical case can be made for such screening: drug use is common and associated with numerous health consequences, patients usually do not seek help, and screening and brief intervention has proven efficacy for other substance use (e.g., alcohol). Policy has advanced based on this case: large federal efforts to disseminate screening and brief intervention are underway, and reimbursement codes for insurers to compensate clinicians for these activities have been developed. The discrepancy between the science and these policy developments underscore the need to test brief intervention's efficacy among patients identified by screening. The objective of this study, the Assessing Screening Plus brief Intervention's Resulting Efficacy to stop drug use (the ASPIRE) Study, is to determine the efficacy of two models of brief intervention for decreasing drug use and consequences in primary care patients. In collaboration with a state project implementing screening and brief intervention as part of a federal program, we will screen patients in a large hospital-based primary care practice for drug use. We will then enroll 1,800 screen-positive subjects, randomly assign them to 1 of 3 groups, and follow them for 6 months. Subjects in one intervention group will be assigned to a standard brief intervention model, conducted by trained health promotion advocates as part of local implementation of a widely disseminated federal program. In another group, subjects will be assigned to an enhanced, more-intensive brief intervention model that includes a booster contact and is conducted by master's-level counselors trained and monitored intensively to perform motivational interviewing. The control group will receive information (i.e., a written list of local resources to help people using drugs) and, at the end of six months, standard brief intervention if they are still using drugs. Primary outcomes are abstinence from drug use and drug use consequences including HIV- risk behaviors at 6 months, and receipt of substance dependence treatment (among those with dependence). We will also compare costs and outcomes associated with each group. The main hypotheses are that 1) an enhanced brief intervention model will have greater efficacy than screening and resource information alone (control) for increasing drug abstinence, decreasing drug use consequences (including HIV-risk behaviors), and increasing receipt of treatment, 2) a standard brief intervention model will have greater efficacy than control for the same outcomes, and 3) an enhanced brief intervention will have greater efficacy than a standard brief intervention. We also hypothesize that the enhanced brief intervention will have higher implementation costs but lower net intervention costs (implementation, future healthcare, and crime costs) than the other groups. Results of this study -- efficacy and costs of brief intervention for drug use -- will be essential for making decisions about disseminating drug use screening and brief intervention in primary care settings. Public Health Relevance: Drug use is very costly, can cause much harm, and often goes untreated. Brief interventions offered in primary care settings could reach many people who use drugs. This proposed clinical trial will assess the effectiveness of these brief interventions and is thus relevant because if these brief interventions are proven effective, their dissemination could significantly decrease the national burden of drug use.