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一项评价三种实施干预措施的实用群组随机试验。

A pragmatic cluster randomised trial evaluating three implementation interventions.

机构信息

Centre for Health Related Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK.

出版信息

Implement Sci. 2012 Aug 30;7:80. doi: 10.1186/1748-5908-7-80.

DOI:10.1186/1748-5908-7-80
PMID:22935241
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3457838/
Abstract

BACKGROUND

Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.

METHODS

A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.

RESULTS

Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.

CONCLUSIONS

This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.

TRIAL REGISTRATION

ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

摘要

背景

实施研究旨在通过研究促进将研究成果应用于常规实践的方法来缩小证据与实践之间的差距。已经将高质量的证据总结为指南建议,以表明围手术期禁食时间可以比患者目前经历的时间短得多。本试验的目的是评估三种实施围手术期禁食建议的策略的有效性。

方法

2006 年至 2009 年,采用具有帕里什框架的实用群组随机试验,对英国全国范围内的医院进行了时间序列混合方法过程评估和成本分析。医院被随机分为三组干预措施之一:标准传播(SD)指南包,SD 加由意见领袖倡导的基于网络的资源,以及 SD 加计划-执行-研究-行动(PDSA)。主要结局是诱导麻醉前液体禁食的持续时间。次要结局包括禁食时间、患者体验以及利益相关者对实施的体验,包括影响。使用方差分析检验随时间和干预的差异。

结果

19 家急性 NHS 医院参与。在各时间点,共记录了 3505 个禁食时间观察值。未观察到干预措施对液体或食物禁食时间有显著影响。与单独的 SD 相比,网络干预的效果大小为 0.33,用于液体禁食的变化,与单独的 SD 相比,PDSA 的效果大小为 0.12。过程评估显示了不同类型的影响,包括实践、政策和态度的变化。实施挑战的丰富画面出现了,包括专业之间的紧张关系以及决策权力和责任的不明确。

结论

这是一项大型、复杂的研究,也是在实施研究中在急症护理领域进行的首批全国性随机对照试验之一。参与这项研究的人接受了禁食实践的证据基础,其信息简单易懂;然而,实施和实际挑战影响了干预措施的影响。从这项研究的结果中出现了一套实施条件,这些条件作为具有国际相关性的理论上可转移的命题提出。

试验注册

ISRCTN80324323--围手术期实施研究评估(POISE)。

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