此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions (Fluxim)

The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Second to study barriers and facilitators for guideline adherence and to develop and test a tailored implementation strategy, based on these findings.

研究概览

地位

未知

详细说明

The most important cause of maternal morbidity in the Netherlands is Haemorrhagia post partum (HPP), with an incidence of 5% containing 10.000 women in the Netherlands a year. Introduction of an evidence-based guideline about HPP by the Dutch society of Obstetrics and Gynaecology (NVOG) and the course Management of Obstetrics Emergencies and Trauma (MOET course) did not lead to a reduction in HPP. This implies the possibility of an incomplete implementation of both the NVOG guideline and MOET-instructions.

To evaluate the implementation of the guideline and MOET instruction in the current care, measurement of the actual care will be performed in a representative sample of 20 hospitals. Before actual care can be measured, quality indicators have to be developed regarding the process, structure and outcome based on the key recommendations from the NVOG guideline on HPP and the MOET instructions. The indicator development will be performed according to the RAND-modified Delphi method .The key recommendations from the NVOG guideline on HPP and the MOET instructions will be extracted and will be tested in two rounds among an independent panel of 12-15. The selected key recommendations will be operationalized in measurable elements. In an observational multi-centre study, actual care will be measured by video monitoring the third stage of delivery and a medical record search among 320 high risk patients for HPP in 20 hospitals. Additional information for indicator adherence will be searched in the medical records of the videotaped patients. In this manner, deviations from the indicators can be outlined. This study will provide us with reliable information about current practice in the Netherlands.

A qualitative study will be performed with the aim to discover factors in detail that are "pro" or "contra" adhering to the developed HPP-indicators by focus group interviews among groups of different involved professionals and experienced patients. Subsequently, to assess the 'prevalence' of the factors mentioned in the focus group interviews, a survey with questionnaires will be performed among all Dutch gynaecologists and midwives. The data will be analyzed to assess the most frequently mentioned barriers and facilitators.

Based on the results of step 1 and 2, a tailored implementation strategy will be developed to increase the adherence to the recommendations. The different implementation elements will be tailored to the barriers and facilitators found and will probably combine interventions directed at professional and organizational level. This strategy will be implemented and evaluated in a feasibility study. The study will be performed in 3 hospitals where the effect of the implementation strategy, the adherence to the developed indicators will be measured. A process evaluation will be performed to study the experiences of the clinicians and patients with this strategy. A cost analysis of the tested implementation strategy will take place.

研究类型

观察性的

注册 (预期的)

320

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nijmegen、荷兰、6500 HB
        • Radboud University Nijmegen Medical Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

women with a high risk for haemorrhagia postpartum delivering in a hospital

描述

Inclusion Criteria:

  • woman with a high risk for haemorrhagia post partum

Exclusion Criteria:

  • woman who refuses to participate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:仅案例
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Haemorrhagia post partum
Women with a high risk for haemorrhagia post partum.
testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions).
大体时间:1 year
1 year
feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators.
大体时间:1 years
1 years
barrier analysis
大体时间:1 year
the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators
1 year

次要结果测量

结果测量
大体时间
actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care.
大体时间:1 year
1 year
feasibility study: the secondary outcome measures are the experiences of professionals and patients with the different elements of the implementation strategy and the changed care, and the cost of the tested strategy.
大体时间:1 year
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rosella Hermens, PhD、IQ healthcare, Radboud University Nijmegen Medical Centre

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年1月1日

初级完成 (预期的)

2013年8月1日

研究完成 (预期的)

2013年8月1日

研究注册日期

首次提交

2009年6月25日

首先提交符合 QC 标准的

2009年6月25日

首次发布 (估计)

2009年6月26日

研究记录更新

最后更新发布 (估计)

2013年5月24日

上次提交的符合 QC 标准的更新

2013年5月22日

最后验证

2013年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅