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IMPROvEMENT study

 

Go to the Improvement website

 

Improving the implementation of tailored expectant management in subfertile couples; a cluster randomised trial
 
Background
Prognostic models in reproductive medicine can help to identify subfertile couples that would benefit from fertility treatment. An expectant management in couples with a good chance of a natural conception prevents unnecessary treatment and is recommended in the subfertility guidelines of NVOG and NHG. However, actual implementation is not optimal, leaving a strong potential for improvement. In preparation of the present study, we have performed qualitative and quantitative studies among subfertile couples and professionals, in which we have identified several barriers and facilitators of tailored expectant management (TEM). The results of these studies have been used to develop an implementation strategy.
 
Objective
The main goal is to investigate how an increase in the implementation of tailored expectant management in Dutch fertility care can be best achieved. In this study we want to determine the effects of a multifaceted implementation strategy compared to usual care (no strategy) with regard to the number couples with a good prognosis suitable for tailored expectant management.
 
Study design
In a cluster randomised trial, clinics and their allied general practitioner units are randomised between the multifaceted implementation strategy versus usual care. The effect of the strategy will be evaluated by a pre- and post-randomisation data collection and a process evaluation.
 
Study population
The implementation strategy will focus on subfertile couples in primary and secondary care and on general practitioners, fertility doctors and gynaecologists.
 
Intervention
Tailored expectant management for 6-12 months in couples with a good prognosis for a natural conception.
 
Implementation strategy
The multifaceted implementation strategy is developed based on the prior barrier and facilitator analysis (van den Boogaard, 2011).

Outcome
The primary outcome will be adherence of tailored expectant management measured by % couples with a good prognosis and a tailored expectant.
Secondary outcomes: treatment outcome related measures, process related measures and patient related measures (FertiQol)
 
Power/data analysis
The adherence to tailored expectant management at the moment is approximately 60% (van den Boogaard 2011, in press). To increase this percentage from 60% to 80% with an Intra Class Correlation of 0.10, P<0.05, comparing 2 strategies, we need 22 clinics with at least 30 couples per year.
 
Economic evaluation
We will determine the cost-effectiveness of the implementation strategy.
 
Projectleaders
Drs. F.A.M. Kersten, UMC St Radboud Nijmegen
Prof. Dr. B.W.J. Mol, AMC Amsterdam
Dr. R. Hermens, UMC St Radboud Nijmegen
Dr. W.L.D.M. Nelen, UMC St Radboud Nijmegen
Dr. M. Goddijn, AMC Amsterdam
Prof. Dr. J. Kremer, UMC St Radboud Nijmegen
Drs. N. van den Boogaard, AMC Amsterdam
Prof. Dr. P. Bossuyt, AMC Amsterdam
Prof. Dr. F. van der Veen, AMC Amsterdam
 
Subsidy
ZonMW
 
Contact
Drs. Fleur Kersten
UMC St Radboud Nijmegen
Tel: 024-3668666/06-54791464
email:
Improvement@studies-obsgyn.nl