Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care (SIMPLE)

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:

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.

Study Overview

• Status: Unknown
• Conditions: Caesarean Section
• Intervention / Treatment: Other: Implementation aids

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Netherlands
  • Almelo, Netherlands
    • Ziekenhuisgroep Twente
  • Almere, Netherlands
    • Flevo ziekenhuis
  • Amersfoort, Netherlands
    • Meander Medisch Centrum
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum
  • Apeldoorn, Netherlands
    • Gelreziekenhuizen
  • Arnhem, Netherlands
    • Rijnstate Ziekenhuis
  • Capelle aan den Ijjsel, Netherlands
    • IJsselland ziekenhuis
  • Eindhoven, Netherlands
    • Catharina-ziekenhuis
  • Groningen, Netherlands
    • University Medical Centre Groningen
  • Hardenberg, Netherlands
    • Ropcke-Zweers Ziekenhuis
  • Heerlen, Netherlands
    • Atrium Medisch Centrum Parkstad
  • Helmond, Netherlands
    • Elkerliek Ziekenhuis
  • Hilversum, Netherlands
    • Tergooiziekenhuizen
  • Maastricht, Netherlands
    • Maastricht Universitair Medisch Centrum
  • Nijmegen, Netherlands
    • Universitair Medisch Centrum St. Radboud
  • Sittard, Netherlands
    • Orbis Medisch Centrum
  • Utrecht, Netherlands
    • Universitair Medisch Centrum Utrecht
  • Veldhoven, Netherlands
    • Máxima Medisch Centrum
  • Weert, Netherlands
    • Sint Jansgasthuis
  • Zaandam, Netherlands
    • Zaans Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

1. Development of quality indicators: 12-15 obstetricians and midwives
2. 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.
3. 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.
4. 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections	December 2010 - October 2013
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	December 2010 - October 2013
3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section	December 2010 - October 2013
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	December 2010 - October 2013

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1) Development of quality indicators: no secondary outcomes		December 2010 - October 2013
2) Current care study: International comparison	Dutch practice as compared to international data (Robson criteria)	December 2010- October 2013
3) Barrier and facilitator analysis: no secondary outcomes		December 2010-October 2013
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		December 2010-October 2013

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Hubertina CJ Scheepers, Ph.D., Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 29, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: caesarean section; implementation guidelines; quality indicators; labour, obstetric
• Other Study ID Numbers: 09-4-047; 17100.3006 (Other Grant/Funding Number: zonMW)