Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care
NCT ID: NCT01261676
Last Updated: 2012-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2010-12-31
Brief Summary
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Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS among Dutch gynaecologists.
This study consists of four phases:
1. 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.
2. 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.
3. 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.
4. 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Caesarean section
Implementation aids
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)
Implementation aids
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)
Interventions
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Implementation aids
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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Fetal death prior to onset of delivery
* Duration of pregnancy less than 24 weeks of gestation
FEMALE
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Hubertina CJ Scheepers, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Ziekenhuisgroep Twente
Almelo, , Netherlands
Flevo Ziekenhuis
Almere Stad, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Gelreziekenhuizen
Apeldoorn, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Ijsselland Ziekenhuis
Capelle Aan Den Ijjsel, , Netherlands
Catharina-ziekenhuis
Eindhoven, , Netherlands
University Medical Centre Groningen
Groningen, , Netherlands
Röpcke-Zweers Ziekenhuis
Hardenberg, , Netherlands
Atrium Medisch Centrum Parkstad
Heerlen, , Netherlands
Elkerliek Ziekenhuis
Helmond, , Netherlands
Tergooiziekenhuizen
Hilversum, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Universitair Medisch Centrum St. Radboud
Nijmegen, , Netherlands
Orbis Medisch Centrum
Sittard, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Sint Jansgasthuis
Weert, , Netherlands
Zaans Medisch Centrum
Zaandam, , Netherlands
Countries
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References
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Melman S, Schoorel EN, Dirksen C, Kwee A, Smits L, de Boer F, Jonkers M, Woiski MD, Mol BW, Doornbos JP, Visser H, Huisjes AJ, Porath MM, Delemarre FM, Kuppens SM, Aardenburg R, Van Dooren IM, Vrouenraets FP, Lim FT, Kleiverda G, van der Salm PC, de Boer K, Sikkema MJ, Nijhuis JG, Hermens RP, Scheepers HC. SIMPLE: implementation of recommendations from international evidence-based guidelines on caesarean sections in the Netherlands. Protocol for a controlled before and after study. Implement Sci. 2013 Jan 3;8:3. doi: 10.1186/1748-5908-8-3.
Other Identifiers
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17100.3006
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
09-4-047
Identifier Type: -
Identifier Source: org_study_id