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基层医疗实施研究,以扩大社区层面的早期识别和简短干预,并减少与酒精相关的不良后果 (PINO):一项准实验性 3 臂研究的研究方案。

Primary care implementation study to scale up early identification and brief intervention and reduce alcohol-related negative outcomes at the community level (PINO): study protocol for a quasi-experimental 3-arm study.

机构信息

Academic Centre for General Practice, Kapucijnenvoer 33 blok H - bus 7001, 3001, Leuven, KU, Belgium.

出版信息

BMC Fam Pract. 2021 Jul 1;22(1):144. doi: 10.1186/s12875-021-01479-9.

DOI:10.1186/s12875-021-01479-9
PMID:34210261
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8248288/
Abstract

BACKGROUND

Primary healthcare-based Early Identification and Brief Intervention (EIBI) for hazardous and harmful alcohol use is both a clinically relevant and cost-effective strategy to reduce heavy drinking. Unfortunately, it remains poorly implemented in daily practice. Multiple studies have shown that training and support (T&S) programs can increase the use of EIBI. Nonetheless, gains have only been modest and short-term at best. Suggestions have been made to rely more on multicomponent programs that simultaneously address several barriers to the implementation of EIBI. The PINO-project aims to evaluate the added value of such a multicomponent program to improve EIBI delivery in daily practice.

METHODS/DESIGN: A quasi-experimental three-arm implementation study in Flanders (Belgium) will assess the effects of tailored T&S to General Practitioners (GPs) with or without community mobilisation on EIBI delivery in general practice. The study lasts 18 months and will take place in three comparable municipalities. In municipality 1 and 2, GPs receive a tailored T&S program. The T&S is theoretically founded and tailored to the GPs' views, needs and practice characteristics. Furthermore, community actions will be embedded within municipality 1 providing additional, contextual, support. In municipality 3, GPs are offered a minimal intervention to facilitate data collection. The primary outcome is the proportion of adult patients screened for hazardous and harmful alcohol use at the end of an 18-month implementation period. The secondary outcome is the scaling up activity at municipal level in screening rates, as assessed every 3 months, and the proportion of patients who received an additional brief intervention when necessary. Furthermore, the correlation between the opinions and needs of the GP's, their practice organisation and their EIBI performance will be explored.

DISCUSSION

The PINO-project addresses the gap between what is theoretically possible and the current practice. This is an innovative study combining T&S at GP level with community actions. At the same time, it implements and evaluates practice T&S based on the theoretical domains framework.

TRIAL REGISTRATION

This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (reference number s63342 and G-2020-2177-R2(MAR)) and is registered on clinicaltrials.gov ( NCT04398576 ) in May 2020.

摘要

背景

以初级保健为基础的早期识别和简短干预(EIBI)对于危险和有害的酒精使用是一种具有临床相关性和成本效益的策略,可以减少重度饮酒。不幸的是,它在日常实践中仍然执行不力。多项研究表明,培训和支持(T&S)计划可以增加 EIBI 的使用。尽管如此,收益最多也只是适度和短期的。有人建议更多地依赖同时解决实施 EIBI 若干障碍的多组分方案。PINO 项目旨在评估这种多组分方案的附加价值,以改善日常实践中的 EIBI 提供。

方法/设计:在比利时弗拉芒地区进行的一项准实验性三臂实施研究将评估针对全科医生(GP)的量身定制的 T&S 对 EIBI 在一般实践中的提供的影响,是否有社区动员。研究持续 18 个月,将在三个可比的城市进行。在城市 1 和 2,GP 接受量身定制的 T&S 计划。T&S 是基于理论并针对 GP 的观点、需求和实践特征量身定制的。此外,将在城市 1 嵌入社区行动,提供额外的、背景相关的支持。在城市 3,GP 将获得一项最低干预措施,以促进数据收集。主要结果是在 18 个月的实施期结束时筛查危险和有害酒精使用的成年患者的比例。次要结果是每 3 个月评估一次的筛查率在市级层面上的扩大活动以及必要时接受额外简短干预的患者比例。此外,还将探索 GP 的意见和需求、他们的实践组织以及他们的 EIBI 表现之间的相关性。

讨论

PINO 项目解决了理论上可行与当前实践之间的差距。这是一项创新性研究,将 GP 层面的 T&S 与社区行动相结合。同时,它基于理论领域框架实施和评估实践 T&S。

试验注册

该试验得到了鲁汶天主教大学UZ/KU 伦理研究委员会的批准(编号为 s63342 和 G-2020-2177-R2(MAR)),并于 2020 年 5 月在 clinicaltrials.gov 上注册(NCT04398576)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35bc/8252250/e4133d9ca89d/12875_2021_1479_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35bc/8252250/e4133d9ca89d/12875_2021_1479_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35bc/8252250/e4133d9ca89d/12875_2021_1479_Fig1_HTML.jpg

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