'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
NCT ID: NCT00119925
Last Updated: 2008-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
5200 participants
INTERVENTIONAL
2005-10-31
2009-05-31
Brief Summary
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Detailed Description
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However, guidelines in general do not implement themselves; large gaps consists between best evidence (as described in the guidelines) and practice, resulting in a large variation between professionals.
Our study will compare an innovative patient-directed strategy with a (minimal intervention) control strategy, and effectiveness, costs and feasibility of both will be assessed. We eventually aim at the most cost-effective strategy to implement the existing subfertility guideline programme.
Please Note: In our protocol, we consider only 'couples' undergoing fertility treatment; therefore, we aim at gathering information from approximately 5200 records, of both male and female participants. When reporting eventually on their treatment, we will consider them only as couples, resulting in reported numbers of approximately 2600 participating couples.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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minimal intervention
professional audit and feedback on current practice
professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
maximal intervention
multi-faceted intervention consisting of professional and patient elements
patient education
patient leaflets about national guideline contents
professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
professional education (communication/shared decision making)
educational tools for professionals concerning communication and shared decision making
information tools
tools and checklists to improve information provision
Interventions
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patient education
patient leaflets about national guideline contents
professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
professional education (communication/shared decision making)
educational tools for professionals concerning communication and shared decision making
information tools
tools and checklists to improve information provision
Eligibility Criteria
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Inclusion Criteria
* each patient admitted to the hospital with complications of an infertility treatment
Exclusion Criteria
* patients receiving ICSI treatment
* patients who are non-Dutch speaking or understand too little Dutch to fill out the questionnaires
18 Years
80 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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dept. of Obstetrics and Gynecology
Principal Investigators
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Rosella PMG Hermens, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Quality of Care Research
Jan AM Kremer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre
Didi D Braat, Prof. MD PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre
Richard PT Grol, Prof. PhD
Role: STUDY_CHAIR
Centre for Quality of Care Research
E Adang
Role: STUDY_DIRECTOR
Department of Medical Technology Assessment, Radboud University Nijmegen Medical Centre
J MM van Lith, MD, PhD
Role: STUDY_DIRECTOR
Dutch Society of Obstetrics and Gynecology
G Zielhuis, Prof PhD
Role: STUDY_DIRECTOR
Department of Epidemiology and Biostatistics, Radboud University Nijmegen Medical Centre
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Gelre Ziekenhuizen
Apeldoorn, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Maasziekenhuis Pantein
Boxmeer, , Netherlands
ZBC stichting Geertgen
De Mortel, , Netherlands
Slingeland Ziekenhuis
Doetinchem, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
st Antonius Ziekenhuis
Nieuwegein, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Bernhoven Ziekenhuis
Oss, , Netherlands
Rivierenland Ziekenhuis
Tiel, , Netherlands
Bernhoven Ziekenhuis
Veghel, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Streekziekenhuis Zevenaar
Zevenaar, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Carl Hamilton, MD
Role: primary
Laurens j van Dam, MD
Role: primary
Alex P Schmoutziguer, MD
Role: primary
Ineke Minkhorst, MD
Role: primary
Henk Ruis, MD
Role: primary
Eveline Tepe, MD
Role: primary
Eduard Scheenjes, MD
Role: primary
Peter A van Dop, MD, PhD
Role: primary
Jules Schagen van Leeuwen, MD
Role: primary
Jan AM Kremer, MD, PhD
Role: primary
Anton Franssen, MD
Role: primary
Jos Vollebergh, MD
Role: primary
Guido Muijsers, MD
Role: primary
Mirjam van Rozendaal, MD
Role: primary
Ben W Mol, MD
Role: primary
Vincent Blom, MD
Role: primary
References
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Mourad SM, Hermens RP, Liefers J, Akkermans RP, Zielhuis GA, Adang E, Grol RP, Nelen WL, Kremer JA. A multi-faceted strategy to improve the use of national fertility guidelines; a cluster-randomized controlled trial. Hum Reprod. 2011 Apr;26(4):817-26. doi: 10.1093/humrep/deq299. Epub 2010 Dec 6.
Related Links
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website of the Centre for Quality of Care (WOK)
Other Identifiers
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ZonMw grant no. 945-14-116
Identifier Type: -
Identifier Source: secondary_id
SPRING 2005-01
Identifier Type: -
Identifier Source: org_study_id
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