Clinical trial NCT01261676: Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care
Official title: Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caesarean Section
Keywords: caesarean section
labour, obstetric
implementation guidelines
quality indicators
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2010-12-16
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections
timeFrame: December 2010 - October 2013
measure: 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
timeFrame: December 2010 - October 2013
measure: 3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section
timeFrame: December 2010 - October 2013
measure: 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
timeFrame: December 2010 - October 2013
Secondary outcomes:
measure: 1) Development of quality indicators: no secondary outcomes
timeFrame: December 2010 - October 2013
measure: 2) Current care study: International comparison
timeFrame: December 2010- October 2013
measure: 3) Barrier and facilitator analysis: no secondary outcomes
timeFrame: December 2010-October 2013
measure: 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
timeFrame: December 2010-October 2013
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Almere
country: Netherlands
facility: Flevo Ziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Apeldoorn
country: Netherlands
facility: Gelreziekenhuizen
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Capelle aan den Ijjsel
country: Netherlands
facility: Ijsselland Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina-ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Hardenberg
country: Netherlands
facility: Röpcke-Zweers Ziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum Parkstad
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St. Radboud
city: Sittard
country: Netherlands
facility: Orbis Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Weert
country: Netherlands
facility: Sint Jansgasthuis
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
Study officials:
affiliation: Maastricht University Medical Center
name: Hubertina CJ Scheepers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.