PRACT: A Pragmatic Randomized Adaptive Clinical Trial to Investigate Controlling Alcohol related harms in a Low-Income Setting; Emergency Department Brief Interventions in Tanzania

PRACT：一项实用的随机适应性临床试验，旨在研究控制低收入环境中的酒精相关危害；

• 批准号: 10555282
• 负责人: Catherine Ann Staton
• 金额: $ 62.18万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-11 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10555282
• 关键词: Accident and Emergency department; Acute; Adoption; Alcohol abuse; Alcohol consumption; Alcohols; Behavior; Behavioral Sciences; Biological; Caring; Cellular Phone; Cessation of life; Clinical Sciences; Clinical Trials; Clinical Trials Design; Data; Development; Effectiveness; Effectiveness of Interventions; Emergency Situation; Evidence based treatment; Frequencies; Goals; Guidelines; Harm Reduction; Health; Injury; Intervention; K-Series Research Career Programs; Language; Low income; Mediation; Mediator; Medical center; Mental Health; Methods; Modification; Motivation; National Institute on Alcohol Abuse and Alcoholism; Nature; Nurses; Patients; Phase; Pragmatic clinical trial; Protocols documentation; Public Health; Randomized; Reporting; Research; Resource-limited setting; Resources; Risk; Risk Factors; Standardization; Tanzania; Testing; Text; Translating; Underserved Population; United States National Institutes of Health; Work; addiction; alcohol abuse therapy; alcohol related consequences; alcohol-related injury; arm; behavioral clinical trial; binge drinking; brief alcohol intervention; brief intervention; care seeking; clinical care; cost; cost effective; drinking behavior; effectiveness evaluation; evidence base; high risk; high risk population; improved; innovation; intervention cost; intervention effect; low and middle-income countries; mHealth; motivational enhancement therapy; patient level intervention; patient population; post intervention; pragmatic trial; psychosocial; reduced alcohol use; treatment as usual; treatment services; young adult

ABSTRACT Alcohol use is rapidly increasing in low- and middle-income countries, where it is inexpensive, readily available, poorly regulated, and there are few resources devoted to promoting safe alcohol use. Like many other limited resource settings, there are no treatment facilities or addiction practitioners in the Kilimanjaro region of Tanzania. For many in this setting, they only seek care after an emergency like an acute injury. From our preliminary work, we have seen that 30% of injury patients presenting for care in the Emergency Department report excess alcohol use and are at risk of a repeat injury. A Brief Intervention based on a motivational interviewing framework has been shown to reduce alcohol use and alcohol-related harms. We have translated and adapted a Brief Intervention for alcohol to the Tanzanian context and Swahili language called “Punguza Pombe Kwa Afya Yako (PPKAY)/ Reduce Alcohol for Your Health.” This project will evaluate this intervention in injury patients presenting for care at the Kilimanjaro Christian Medical Center in Moshi, Tanzania. By using innovative adaptive clinical trial methods, we will expedite the development of the most effective way to integrate this intervention into clinical care. By the end of this project, we will have identified the most effective brief intervention components and be able to characterize the intervention’s effect overall. Additionally, we will standardize adaptive trial methods to revolutionize the science of clinical trials for behavioral sciences in low-resource settings.

摘要 在低收入和中等收入国家，酒精的使用正在迅速增加，在那里，酒精价格低廉，容易获得， 监管不力，用于促进安全饮酒的资源很少。像许多其他有限的 资源设置，有没有治疗设施或成瘾从业者在基利曼哈罗地区的 坦桑尼亚.对于许多在这种情况下，他们只寻求照顾后，紧急情况，如急性损伤。从我们 初步工作，我们已经看到，30%的受伤病人提出的照顾在急诊科 报告过量饮酒，并有再次受伤的风险。基于动机的简短干预 访谈框架已被证明可以减少酒精使用和与酒精相关的危害。我们翻译了 并根据坦桑尼亚的情况和斯瓦希里语的“Punguza”改编了一份关于酒精的简短干预 Pombe Kwa Afya Yako（PPKAY）/减少酒精对你的健康。该项目将评估这一点 干预在莫希的基利曼哈罗基督教医疗中心接受治疗的受伤患者， 坦桑尼亚.通过使用创新的适应性临床试验方法，我们将加快开发最 有效的方法将这种干预纳入临床护理。在这个项目结束时，我们将确定 最有效的简短干预组成部分，并能够描述干预的整体效果。 此外，我们将标准化适应性试验方法，以彻底改变临床试验的科学， 在低资源环境下的行为科学。