Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care (SIMPLE)
2012年10月29日 更新者：Maastricht University Medical Center
Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care.
Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years. CSs have no clear benefit for overall neonatal outcome and are associated with higher maternal complications and high costs. Dutch guidelines offer clear recommendations on factors that have a direct effect on the decision to perform a CS.
Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS among Dutch gynaecologists.
This study consists of four phases:
- Development of quality indicators: A set of quality indicators regarding the process, structure and outcome of care will be developed according to the RAND-modified Delphi method. A representative, national expert panel consisting of 12 to 15 obstetricians and midwives will participate.
- Current care study: The current Dutch care will be studied in 20 hospitals (N=80 gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to the developed quality indicators. To get insight into Dutch practices compared to international data, basic obstetrical data will be extracted from the delivery database.
- Barrier analysis: A barrier analysis will be carried out based on the results of the current care study. Two groups of hospitals will be identified in the upper and lower extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals with the highest adherence scores. Factors that determine the decision to perform a CS or not (barriers and facilitators) will be analyzed in both groups using semi-structured interviews among 15-20 professionals and 15-20 patients. A questionnaire will be used to study the 'prevalence' of these factors among all obstetric gynaecologists in the Netherlands and among 200 patients.
- Controlled before- and-after (CBA) study: Based on the outcomes of the current care study and the barrier analysis, a tailor made implementation strategy will be developed in order to increase adherence to the CS quality indicators. Target groups will be selected with focus on women with both a high incidence of the indicator and low indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12 hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs. The sample size will be dependent on the target group and adherence to the quality indicators regarding this target group. These data will be available after performing the current care and the barrier study.
研究概览
研究类型
观察性的
注册 (预期的)
1000
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
-
-
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Almelo、荷兰
- Ziekenhuisgroep Twente
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Almere、荷兰
- Flevo ziekenhuis
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Amersfoort、荷兰
- Meander Medisch Centrum
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Amsterdam、荷兰
- Academisch Medisch Centrum
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Apeldoorn、荷兰
- Gelreziekenhuizen
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Arnhem、荷兰
- Rijnstate Ziekenhuis
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Capelle aan den Ijjsel、荷兰
- IJsselland Ziekenhuis
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Eindhoven、荷兰
- Catharina-Ziekenhuis
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Groningen、荷兰
- University Medical Centre Groningen
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Hardenberg、荷兰
- Ropcke-Zweers Ziekenhuis
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Heerlen、荷兰
- Atrium Medisch Centrum Parkstad
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Helmond、荷兰
- Elkerliek Ziekenhuis
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Hilversum、荷兰
- Tergooiziekenhuizen
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Maastricht、荷兰
- Maastricht Universitair Medisch Centrum
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Nijmegen、荷兰
- Universitair Medisch Centrum St. Radboud
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Sittard、荷兰
- Orbis Medisch Centrum
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Utrecht、荷兰
- Universitair Medisch Centrum Utrecht
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Veldhoven、荷兰
- Maxima Medisch Centrum
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Weert、荷兰
- Sint Jansgasthuis
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Zaandam、荷兰
- Zaans Medisch Centrum
-
-
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
- 孩子
- 成人
- 年长者
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
- Development of quality indicators: 12-15 obstetricians and midwives
- Current care study: All women (1000) who underwent a CS in one of the 20 participating hospitals during the study period (3-4 months). All hospitals participate in the Dutch consortium and consist of university teaching-, non-university teaching- and non-university-non-teaching hospitals.
- Barrier analysis: Qualitative: 15-20 professionals and 15-20 patients from the hospitals in the upper and lower extremes of the 'adherence distribution'. Quantitative: obstetricians in the Netherlands and 200 experienced patients.
- CBA study: depending on the outcome of phase 2 and 3 of the study, the implementation strategy will be designed for a target group with low guideline adherence and high incidence.
描述
Inclusion Criteria:
- A previous caesarean section in a 3-4 month time period.
Exclusion Criteria:
- Major congenital malformality
- Fetal death prior to onset of delivery
- Duration of pregnancy less than 24 weeks of gestation
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Caesarean section
|
An implementation strategy to improve outcome for women in labour will be developed depending on the outcome of the current care study and the barrier and facilitator analysis.The strategy will be executed and evaluated in a controlled before-and-after study in 12 hospitals (6 intervention, 6 control)
|
|
Vaginal birth (control)
|
An implementation strategy to improve outcome for women in labour will be developed depending on the outcome of the current care study and the barrier and facilitator analysis.The strategy will be executed and evaluated in a controlled before-and-after study in 12 hospitals (6 intervention, 6 control)
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections
大体时间：December 2010 - October 2013
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December 2010 - October 2013
|
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2) Current care study: The main outcome is the adherence to the quality indicators regarding the process, structure and outcome (maternal and fetal) of care
大体时间：December 2010 - October 2013
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December 2010 - October 2013
|
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3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section
大体时间：December 2010 - October 2013
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December 2010 - October 2013
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4) Controlled before-and-after study: effectiveness of the implementation strategy defined as observed increase in adherence between the intervention and control hospitals and actual CS rates in both groups
大体时间：December 2010 - October 2013
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December 2010 - October 2013
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1) Development of quality indicators: no secondary outcomes
大体时间：December 2010 - October 2013
|
December 2010 - October 2013
|
|
|
2) Current care study: International comparison
大体时间：December 2010- October 2013
|
Dutch practice as compared to international data (Robson criteria)
|
December 2010- October 2013
|
|
3) Barrier and facilitator analysis: no secondary outcomes
大体时间：December 2010-October 2013
|
December 2010-October 2013
|
|
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4) Controlled before-and-after study: experiences and satisfaction of health care providers and patients with the implementation strategy and applicability and costs of the strategy
大体时间：December 2010-October 2013
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December 2010-October 2013
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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：Hubertina CJ Scheepers, Ph.D.、Maastricht University Medical Center
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。
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12月1日
初级完成 (预期的)
2013年10月1日
研究注册日期
首次提交
2010年12月15日
首先提交符合 QC 标准的
2010年12月15日
首次发布 (估计)
2010年12月16日
研究记录更新
最后更新发布 (估计)
2012年10月30日
上次提交的符合 QC 标准的更新
2012年10月29日
最后验证
2012年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 09-4-047
- 17100.3006 (其他赠款/资助编号：zonMW)
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