Kaner Eileen, Bland Martin, Cassidy Paul, Coulton Simon, Deluca Paolo, Drummond Colin, Gilvarry Eilish, Godfrey Christine, Heather Nick, Myles Judy, Newbury-Birch Dorothy, Oyefeso Adenekan, Parrott Steve, Perryman Katherine, Phillips Tom, Shenker Don, Shepherd Jonathan
Institute of Health and Society, Newcastle University, Newcastle, UK.
BMC Public Health. 2009 Aug 10;9:287. doi: 10.1186/1471-2458-9-287.
There have been many randomized controlled trials of screening and brief alcohol intervention in primary care. Most trials have reported positive effects of brief intervention, in terms of reduced alcohol consumption in excessive drinkers. Despite this considerable evidence-base, key questions remain unanswered including: the applicability of the evidence to routine practice; the most efficient strategy for screening patients; and the required intensity of brief intervention in primary care. This pragmatic factorial trial, with cluster randomization of practices, will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in primary care and different intensities of brief intervention to reduce excessive drinking in primary care patients.
GPs and nurses from 24 practices across the North East (n=12), London and South East (n=12) of England will be recruited. Practices will be randomly allocated to one of three intervention conditions: a leaflet-only control group (n=8); brief structured advice (n=8); and brief lifestyle counselling (n=8). To test the relative effectiveness of different screening methods all practices will also be randomised to either a universal or targeted screening approach and to use either a modified single item (M-SASQ) or FAST screening tool. Screening randomisation will incorporate stratification by geographical area and intervention condition. During the intervention stage of the trial, practices in each of the three arms will recruit at least 31 hazardous or harmful drinkers who will receive a short baseline assessment followed by brief intervention. Thus there will be a minimum of 744 patients recruited into the trial.
The trial will evaluate the impact of screening and brief alcohol intervention in routine practice; thus its findings will be highly relevant to clinicians working in primary care in the UK. There will be an intention to treat analysis of study outcomes at 6 and 12 months after intervention. Analyses will include patient measures (screening result, weekly alcohol consumption, alcohol-related problems, public service use and quality of life) and implementation measures from practice staff (the acceptability and feasibility of different models of brief intervention.) We will also examine organisational factors associated with successful implementation.
Current Controlled Trials ISRCTN06145674.
在初级保健中，已经进行了许多关于筛查和简短酒精干预的随机对照试验。大多数试验报告了简短干预的积极效果，即减少了过度饮酒者的酒精消费量。尽管有大量的证据基础，但关键问题仍然没有答案，包括：证据在常规实践中的适用性；筛查患者的最有效策略；以及初级保健中简短干预所需的强度。这项实用的析因试验，采用实践的整群随机化方法，将评估不同筛查模型在初级保健中识别危险和有害饮酒者的有效性和成本效益，以及不同强度的简短干预在减少初级保健患者过度饮酒方面的有效性和成本效益。
将招募来自英格兰东北部（n = 12）、伦敦和东南部（n = 12）的24家医疗机构的全科医生和护士。这些医疗机构将被随机分配到三种干预条件之一：仅提供传单的对照组（n = 8）；简短的结构化建议组（n = 8）；以及简短的生活方式咨询组（n = 8）。为了测试不同筛查方法的相对有效性，所有医疗机构还将被随机分配到普遍筛查或目标筛查方法，并使用改良单项筛查问卷（M - SASQ）或快速筛查工具。筛查随机化将纳入按地理区域和干预条件的分层。在试验的干预阶段，三个组中的每个组的医疗机构将招募至少31名危险或有害饮酒者，他们将接受简短的基线评估，然后接受简短干预。因此，至少将有744名患者被纳入试验。
该试验将评估筛查和简短酒精干预在常规实践中的影响；因此，其结果将与在英国初级保健领域工作的临床医生高度相关。将在干预后6个月和12个月对研究结果进行意向性分析。分析将包括患者测量指标（筛查结果、每周酒精消费量、与酒精相关的问题、公共服务使用情况和生活质量）以及来自医疗机构工作人员的实施测量指标（不同简短干预模型的可接受性和可行性）。我们还将研究与成功实施相关的组织因素。
当前受控试验ISRCTN06145674。
