Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care (SIMPLE)
29 oktober 2012 uppdaterad av: 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.
Studieöversikt
Studietyp
Observationell
Inskrivning (Förväntat)
1000
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Almelo, Nederländerna
- Ziekenhuisgroep Twente
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Almere, Nederländerna
- Flevo ziekenhuis
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Amersfoort, Nederländerna
- Meander Medisch Centrum
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Amsterdam, Nederländerna
- Academisch Medisch Centrum
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Apeldoorn, Nederländerna
- Gelreziekenhuizen
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Arnhem, Nederländerna
- Rijnstate Ziekenhuis
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Capelle aan den Ijjsel, Nederländerna
- IJsselland Ziekenhuis
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Eindhoven, Nederländerna
- Catharina-Ziekenhuis
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Groningen, Nederländerna
- University Medical Centre Groningen
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Hardenberg, Nederländerna
- Ropcke-Zweers Ziekenhuis
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Heerlen, Nederländerna
- Atrium Medisch Centrum Parkstad
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Helmond, Nederländerna
- Elkerliek Ziekenhuis
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Hilversum, Nederländerna
- Tergooiziekenhuizen
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Maastricht, Nederländerna
- Maastricht Universitair Medisch Centrum
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Nijmegen, Nederländerna
- Universitair Medisch Centrum St. Radboud
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Sittard, Nederländerna
- Orbis Medisch Centrum
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Utrecht, Nederländerna
- Universitair Medisch Centrum Utrecht
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Veldhoven, Nederländerna
- Maxima Medisch Centrum
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Weert, Nederländerna
- Sint Jansgasthuis
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Zaandam, Nederländerna
- Zaans Medisch Centrum
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
- 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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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)
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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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections
Tidsram: 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
Tidsram: December 2010 - October 2013
|
December 2010 - October 2013
|
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3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section
Tidsram: 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
Tidsram: December 2010 - October 2013
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December 2010 - October 2013
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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1) Development of quality indicators: no secondary outcomes
Tidsram: December 2010 - October 2013
|
December 2010 - October 2013
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2) Current care study: International comparison
Tidsram: December 2010- October 2013
|
Dutch practice as compared to international data (Robson criteria)
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December 2010- October 2013
|
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3) Barrier and facilitator analysis: no secondary outcomes
Tidsram: 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
Tidsram: December 2010-October 2013
|
December 2010-October 2013
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Hubertina CJ Scheepers, Ph.D., Maastricht University Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2010
Primärt slutförande (Förväntat)
1 oktober 2013
Studieregistreringsdatum
Först inskickad
15 december 2010
Först inskickad som uppfyllde QC-kriterierna
15 december 2010
Första postat (Uppskatta)
16 december 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 oktober 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 oktober 2012
Senast verifierad
1 oktober 2012
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 09-4-047
- 17100.3006 (Annat bidrag/finansieringsnummer: zonMW)
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