Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care (SIMPLE)
This study is enrolling participants by invitation only.
Sponsor:
Maastricht University Medical Center
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01261676
First received: December 15, 2010
Last updated: October 29, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Caesarean Section |
Other: Implementation aids |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care. |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- 1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
- 3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 1) Development of quality indicators: no secondary outcomes [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
- 2) Current care study: International comparison [ Time Frame: December 2010- October 2013 ] [ Designated as safety issue: No ]Dutch practice as compared to international data (Robson criteria)
- 3) Barrier and facilitator analysis: no secondary outcomes [ Time Frame: December 2010-October 2013 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: December 2010-October 2013 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Caesarean section |
Other: 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) |
Other: 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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
- 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261676
Locations
| Netherlands | |
| Ziekenhuisgroep Twente | |
| Almelo, Netherlands | |
| Flevo Ziekenhuis | |
| Almere, 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 | |
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Hubertina CJ Scheepers, Ph.D. | Maastricht University Medical Center |
More Information
Additional Information:
No publications provided by Maastricht University Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01261676 History of Changes |
| Other Study ID Numbers: | 09-4-047, 17100.3006 |
| Study First Received: | December 15, 2010 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
caesarean section labour, obstetric implementation guidelines quality indicators |
ClinicalTrials.gov processed this record on May 21, 2013